thalidomide has been researched along with Invasiveness, Neoplasm in 19 studies
Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.
2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Thalidomide is an antiangiogenic drug that produces a response rate ranging from 32 to 64% in patients with refractory/relapsed multiple myeloma (MM)." | 7.72 | Extramedullary multiple myeloma escapes the effect of thalidomide. ( Aymerich, M; Bladé, J; Cibeira, MT; Cid, MC; Esteve, J; Filella, X; Montserrat, E; Rosiñol, L; Rozman, M; Segarra, M, 2004) |
| "Thalidomide treatment significantly decreased the invasive cells number through Matrigel and human umbilical vein endothelial cells when compared with the controls." | 5.35 | Thalidomide inhibits leukemia cell invasion and migration by upregulation of early growth response gene 1. ( Li, J; Liu, P; Lu, H; Xu, B, 2009) |
| "To collect outcome data in a large cohort of patients with aggressive pituitary tumours (APT)/carcinomas (PC) and specifically report effects of temozolomide (TMZ) treatment." | 3.88 | Treatment of aggressive pituitary tumours and carcinomas: results of a European Society of Endocrinology (ESE) survey 2016. ( Burman, P; Dekkers, OM; McCormack, A; Petersenn, S; Popovic, V; Raverot, G; Trouillas, J, 2018) |
| "Thalidomide is an antiangiogenic drug that produces a response rate ranging from 32 to 64% in patients with refractory/relapsed multiple myeloma (MM)." | 3.72 | Extramedullary multiple myeloma escapes the effect of thalidomide. ( Aymerich, M; Bladé, J; Cibeira, MT; Cid, MC; Esteve, J; Filella, X; Montserrat, E; Rosiñol, L; Rozman, M; Segarra, M, 2004) |
| "Twenty-six patients with advanced cancer (14 men/12 women), median age of 56 years (range 38-70 years), and a median number of two prior therapies (range 0-12) were enrolled." | 2.80 | Phase I trial of valproic acid and lenalidomide in patients with advanced cancer. ( Abdelrahim, M; Bilen, MA; Erguvan-Dogan, B; Falchook, GS; Fu, S; Hong, DS; Kurzrock, R; Naing, A; Ng, CS; Tsimberidou, AM; Wheler, JJ, 2015) |
| "Thalidomide is a widely used anti-angiogenic and immunomodulatory drug with anticancer effects." | 1.51 | Synergistic effects of gefitinib and thalidomide treatment on EGFR-TKI-sensitive and -resistant NSCLC. ( Guo, Z; Huang, C; Huang, H; Jiang, L; Liao, Y; Liu, J; Liu, Y; Wang, X; Xia, X; Zhang, F, 2019) |
| "Thalidomide treatment significantly decreased the invasive cells number through Matrigel and human umbilical vein endothelial cells when compared with the controls." | 1.35 | Thalidomide inhibits leukemia cell invasion and migration by upregulation of early growth response gene 1. ( Li, J; Liu, P; Lu, H; Xu, B, 2009) |
| "In addition, an in vivo experimental metastasis model also showed that treatment with the drugs resulted in a significantly lower number of metastatic pulmonary nodules relative to control mice." | 1.35 | Inhibition of metastatic potential in colorectal carcinoma in vivo and in vitro using immunomodulatory drugs (IMiDs). ( Bartlett, JB; Dalgleish, AG; Galustian, C; Henry, JY; Liu, WM; Meyer, B, 2009) |
| "Celecoxib is a potent selective COX-2 inhibitor." | 1.33 | [A case report of unresectable gallbladder cancer that responded remarkably to the combination of thalidomide, celecoxib, and gemcitabine]. ( Hada, M; Horiuchi, T; Shinji, H, 2006) |
| "Thalidomide has been reported to have antiangiogenic and antimetastatic effects." | 1.33 | A novel anticancer effect of thalidomide: inhibition of intercellular adhesion molecule-1-mediated cell invasion and metastasis through suppression of nuclear factor-kappaB. ( Chen, CC; Lin, YC; Shun, CT; Wu, MS, 2006) |
| "She was diagnosed as having multiple myeloma and transferred to our department." | 1.32 | [Multiple myeloma of the IgD-lambda type invading CNS]. ( Aikawa, S; Hatta, Y; Horie, T; Ito, T; Kanbe, E; Kitamura, K; Kura, Y; Oka, H; Saiki, M; Sawada, U; Takeuchi, J; Yamazaki, T, 2004) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 9 (47.37) | 29.6817 |
| 2010's | 10 (52.63) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| McCormack, A | 1 |
| Dekkers, OM | 1 |
| Petersenn, S | 1 |
| Popovic, V | 1 |
| Trouillas, J | 1 |
| Raverot, G | 1 |
| Burman, P | 1 |
| Li, Q | 1 |
| Liu, Y | 2 |
| Yu, Y | 1 |
| Guo, HM | 1 |
| Sun, L | 1 |
| Yang, L | 1 |
| Liu, XJ | 1 |
| Nie, ZY | 1 |
| Luo, JM | 1 |
| Xia, X | 1 |
| Liao, Y | 1 |
| Guo, Z | 1 |
| Huang, C | 1 |
| Zhang, F | 1 |
| Jiang, L | 1 |
| Wang, X | 1 |
| Liu, J | 1 |
| Huang, H | 1 |
| Miyao, K | 1 |
| Sakemura, R | 1 |
| Sakai, T | 1 |
| Tsushita, N | 1 |
| Kato, T | 1 |
| Niimi, K | 1 |
| Ono, Y | 1 |
| Sawa, M | 1 |
| Bilen, MA | 1 |
| Fu, S | 1 |
| Falchook, GS | 1 |
| Ng, CS | 1 |
| Wheler, JJ | 1 |
| Abdelrahim, M | 1 |
| Erguvan-Dogan, B | 1 |
| Hong, DS | 1 |
| Tsimberidou, AM | 1 |
| Kurzrock, R | 1 |
| Naing, A | 1 |
| Trněný, M | 1 |
| Lamy, T | 1 |
| Walewski, J | 1 |
| Belada, D | 1 |
| Mayer, J | 1 |
| Radford, J | 1 |
| Jurczak, W | 1 |
| Morschhauser, F | 1 |
| Alexeeva, J | 1 |
| Rule, S | 1 |
| Afanasyev, B | 1 |
| Kaplanov, K | 1 |
| Thyss, A | 1 |
| Kuzmin, A | 1 |
| Voloshin, S | 1 |
| Kuliczkowski, K | 1 |
| Giza, A | 1 |
| Milpied, N | 1 |
| Stelitano, C | 1 |
| Marks, R | 1 |
| Trümper, L | 1 |
| Biyukov, T | 1 |
| Patturajan, M | 1 |
| Bravo, MC | 1 |
| Arcaini, L | 1 |
| Shimizu, T | 1 |
| Kurozumi, K | 2 |
| Ishida, J | 1 |
| Ichikawa, T | 2 |
| Date, I | 2 |
| Liu, P | 1 |
| Li, J | 1 |
| Lu, H | 1 |
| Xu, B | 1 |
| Liu, WM | 1 |
| Henry, JY | 1 |
| Meyer, B | 1 |
| Bartlett, JB | 1 |
| Dalgleish, AG | 1 |
| Galustian, C | 1 |
| Onishi, M | 1 |
| Park, B | 1 |
| Sung, B | 1 |
| Yadav, VR | 1 |
| Chaturvedi, MM | 1 |
| Aggarwal, BB | 1 |
| Vicari, P | 1 |
| Ribas, C | 1 |
| Sampaio, M | 1 |
| Arantes, AM | 1 |
| Yamamoto, M | 1 |
| Filho, JB | 1 |
| Segreto, RA | 1 |
| Bordin, JO | 1 |
| Colleoni, GW | 1 |
| Rosiñol, L | 1 |
| Cibeira, MT | 1 |
| Bladé, J | 1 |
| Esteve, J | 1 |
| Aymerich, M | 1 |
| Rozman, M | 1 |
| Segarra, M | 1 |
| Cid, MC | 1 |
| Filella, X | 1 |
| Montserrat, E | 1 |
| Kitamura, K | 1 |
| Takeuchi, J | 1 |
| Kanbe, E | 1 |
| Oka, H | 1 |
| Saiki, M | 1 |
| Aikawa, S | 1 |
| Kura, Y | 1 |
| Hatta, Y | 1 |
| Yamazaki, T | 1 |
| Ito, T | 1 |
| Sawada, U | 1 |
| Horie, T | 1 |
| Hada, M | 1 |
| Horiuchi, T | 1 |
| Shinji, H | 1 |
| Vaishampayan, UN | 1 |
| Heilbrun, LK | 1 |
| Shields, AF | 1 |
| Lawhorn-Crews, J | 1 |
| Baranowski, K | 1 |
| Smith, D | 1 |
| Flaherty, LE | 1 |
| Lin, YC | 1 |
| Shun, CT | 1 |
| Wu, MS | 1 |
| Chen, CC | 1 |
| Chen, KC | 1 |
| Chang, YL | 1 |
| Pan, CT | 1 |
| Lee, YC | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase 2, Multicenter, Randomized Open-Label Study To Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma[NCT00875667] | Phase 2 | 254 participants (Actual) | Interventional | 2009-04-30 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 69.6 |
| Investigators Choice | 45.1 |
Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 70.1 |
| Investigators Choice | 91.7 |
Overall survival was defined as the time from randomization until death from any cause. Participants alive or lost to follow-up at the time of analysis were censored at the last date they were known to be alive. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; overall median follow-up was 93.9 weeks
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 121.0 |
| Investigators Choice | 91.7 |
Overall survival was defined as the time from randomization until death from any cause. Participants alive or lost to follow-up at the time of analysis were censored at the last date they were known to be alive. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to the study discontinuation date of 09 October 2018; overall median follow-up time was 285 weeks
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 120.6 |
| Investigators Choice | 91.7 |
PFS was defined as time of randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to data cut off date of 07 March 2014; overall median follow-up time was 93.9 weeks
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 37.6 |
| Investigators Choice | 22.7 |
Kaplan Meier estimates of PFS were defined as the time from randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last completed assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to study discontinuation of 09 October 2018; overall median follow-up time was 285 weeks
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 37.3 |
| Investigators Choice | 23.6 |
Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants. ). Participants with progression at the time of analysis were censored at the first assessment date that the participant was known to have progressed. Participants with SD at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From randomization of study drug to time of first documented PR or better response; up to data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 18.7 |
| Investigators Choice | NA |
Time to first response was defined as the time from first dose of study drug to the date of the first response (having at least a PR). Participants with progression at the time of analysis were censored at the first assessment date that the participant was known to have progressed. Participants with SD at the time of analysis were censored at the last assessment date that the subject was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 23.9 |
| Investigators Choice | 40.0 |
Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 39.3 |
| Investigators Choice | 24.7 |
Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 39.3 |
| Investigators Choice | 24.7 |
Time to treatment failure was defined as the time from the first dose of study drug to discontinuation of treatment for any reason, including disease progression assessed by the investigator, treatment toxicity, or death. Participants who were on-treatment or completed the treatment according to the protocol were censored at the last date of drug intake. (NCT00875667)
Timeframe: From the date of the first treatment to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 24.4 |
| Investigators Choice | 17.9 |
Time to treatment failure was defined as the time from the first dose of study drug to discontinuation of treatment for any reason, including disease progression assessed by the investigator, treatment toxicity, or death. Participants who were on-treatment or completed the treatment according to the protocol were censored at the last date of drug intake. (NCT00875667)
Timeframe: From date of first dose of treatment to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 24.4 |
| Investigators Choice | 17.9 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Domain to Treatment Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -4.8 |
| Investigators Choice | -4.1 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 3.2 |
| Investigators Choice | 2.9 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -0.3 |
| Investigators Choice | -3.5 |
"The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Diarhoea Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement." (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Lenalidomide | -7.2 |
| Investigators Choice | -5.8 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Domain to Treatment Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -7.3 |
| Investigators Choice | -5.8 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 6.9 |
| Investigators Choice | 3.7 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -4.9 |
| Investigators Choice | -2.9 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Problems Domain Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -10.9 |
| Investigators Choice | -2.3 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Scale was scored between 0 and 100, with a higher score representing a higher quality of life. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 4.6 |
| Investigators Choice | 5.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -12.8 |
| Investigators Choice | -7.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea and Vomiting Scale was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -2.3 |
| Investigators Choice | -0.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -5.8 |
| Investigators Choice | -3.5 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 3.4 |
| Investigators Choice | -1.8 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 3.1 |
| Investigators Choice | 5.0 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 5.1 |
| Investigators Choice | 3.8 |
Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response (CR), Complete Response unconfirmed (CRu) or Partial Response (PR). Participants who discontinued before any response had been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
| Intervention | Percentage of Participants (Number) |
|---|---|
| Lenalidomide | 40.0 |
| Investigators Choice | 10.7 |
Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
| Intervention | Percentage of Participants (Number) |
|---|---|
| Lenalidomide | 45.9 |
| Investigators Choice | 22.6 |
Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
| Intervention | Percentage of Participants (Number) |
|---|---|
| Lenalidomide | 69.4 |
| Investigators Choice | 63.1 |
Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease. (NCT00875667)
Timeframe: From date of randomization to the discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
| Intervention | Percentage of participants (Number) |
|---|---|
| Lenalidomide | 70.0 |
| Investigators Choice | 65.5 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 16.2 | -0.8 | 5.1 | -12.5 | -11.1 | 5.4 |
| Lenalidomide | 18.1 | 2.5 | 1.9 | -2.3 | -4.3 | 4.8 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 83.6 | -2.3 | 1.3 | 4.2 | 5.6 | -2.3 |
| Lenalidomide | 84.6 | 0.0 | -1.9 | -3.2 | -2.5 | -5.1 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Domain was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 8.6 | -0.8 | 1.3 | 0.0 | 0.0 | 0.8 |
| Lenalidomide | 12.5 | 6.3 | 4.2 | 3.5 | -0.7 | 10.2 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarhoea Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 12.6 | -3.1 | 1.3 | -4.2 | 0.0 | 0.0 |
| Lenalidomide | 15.7 | -3.5 | -4.2 | 2.4 | -2.1 | 1.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Domain was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 21.2 | -0.8 | 0.0 | 4.2 | 5.6 | 0.8 |
| Lenalidomide | 26.5 | -1.6 | -1.4 | -2.9 | 1.4 | 6.0 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 78.5 | 1.3 | 1.3 | -3.1 | 1.4 | -1.5 |
| Lenalidomide | 73.7 | 3.4 | 3.6 | 8.1 | 4.5 | -1.3 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 39.2 | 2.1 | 3.4 | -6.9 | -7.4 | 2.6 |
| Lenalidomide | 40.2 | 0.1 | -3.2 | -1.0 | -3.9 | 5.2 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Problems Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 10.8 | -0.8 | -3.8 | -4.2 | -5.6 | 1.6 |
| Lenalidomide | 19.5 | -7.0 | -7.0 | -2.9 | -9.2 | -4.3 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status / QoL Domain was scored between 0 and 100, with a higher score representing a higher quality of life. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 58.4 | 2.3 | 3.2 | 7.3 | 8.3 | -1.0 |
| Lenalidomide | 59.0 | -3.4 | -0.7 | 1.0 | 4.3 | -5.8 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 25.7 | -4.7 | -6.4 | -16.7 | -16.7 | 0.8 |
| Lenalidomide | 29.4 | -7.6 | -5.2 | -1.8 | -7.1 | -3.2 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea and Vomiting Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 3.8 | 0.4 | 5.8 | 2.1 | 2.8 | 6.6 |
| Lenalidomide | 4.9 | 2.5 | 2.6 | 5.3 | -0.7 | 0.5 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Cycle 3 Day 1 | Cycle 5 Day 1 | Cycle 7 Day 1 | Cycle 9 Day 1 | Treatment Discontinuation | |
| Investigators Choice | 13.7 | -1.2 | -2.6 | 0.0 | -2.8 | 3.5 |
| Lenalidomide | 22.6 | -2.2 | -0.2 | 3.2 | -3.2 | 4.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 78.9 | -3.7 | -2.1 | 4.2 | 11.1 | -5.1 |
| Lenalidomide | 71.8 | -0.5 | 1.6 | 2.4 | 2.8 | -5.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 73.9 | 3.5 | -6.4 | 0.0 | 13.9 | -4.3 |
| Lenalidomide | 71.5 | -4.8 | 1.4 | 0.3 | 1.8 | -9.1 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 78.4 | -1.2 | -4.5 | 2.1 | 0.0 | -2.7 |
| Lenalidomide | 74.9 | -1.0 | 1.6 | -1.5 | 4.3 | -5.1 |
Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A Treatment Emergent Adverse event (TEAE) is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. (NCT00875667)
Timeframe: From the date of the first dose of study drug to 28 days after the last dose, up to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigators choice arm
| Intervention | Participants (Count of Participants) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any TEAE | Any TEAE Grade 3 AE | Any TEAE Grade 4 AE | Any TEAE Grade 5 AE | Any TEAE Related to the IP | Any Grade 3 AE Related to IP | Any Grade 4 AE Related to IP | Any Grade 5 AE Related to IP | Any Serious Adverse Event (SAE) | Any SAE Related to IP | Any TEAE Leading to Stopping of IP | Any Treatment Related AE Leading to Stopping IP | TEAE Leading to Dose Reduction/Interruption | Related AE Leading to Dose Reduct/Interruption | TEAE Leading to Dose Reduction | Related AE Leading to Dose Reduction | TEAE Leading to Dose Interruption | Related AE Leading to Dose Interruption | |
| Investigators Choice | 69 | 49 | 29 | 2 | 51 | 36 | 19 | 0 | 22 | 12 | 14 | 7 | 33 | 29 | 13 | 10 | 28 | 25 |
| Lenalidomide | 159 | 126 | 56 | 15 | 141 | 106 | 46 | 0 | 75 | 38 | 31 | 18 | 114 | 103 | 72 | 69 | 110 | 98 |
3 reviews available for thalidomide and Invasiveness, Neoplasm
| Article | Year |
|---|---|
Antiangiogenic therapy for primitive neuroectodermal tumor with thalidomide: A case report and review of literature.
Topics: Adolescent; Angiogenesis Inhibitors; Biopsy, Needle; Bronchoscopy; Follow-Up Studies; Humans; Immuno | 2017 |
Adhesion molecules and the extracellular matrix as drug targets for glioma.
Topics: Angiogenesis Inhibitors; Antibodies; Brain Neoplasms; Cell Adhesion Molecules; Disease Progression; | 2016 |
Angiogenesis and invasion in glioma.
Topics: Angiogenesis Inhibitors; Animals; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Bevaciz | 2011 |
3 trials available for thalidomide and Invasiveness, Neoplasm
| Article | Year |
|---|---|
Phase I trial of valproic acid and lenalidomide in patients with advanced cancer.
Topics: Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Female; Humans; L | 2015 |
Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial.
Topics: Aged; Angiogenesis Inhibitors; Antineoplastic Agents; Confidence Intervals; Disease-Free Survival; D | 2016 |
Phase II trial of interferon and thalidomide in metastatic renal cell carcinoma.
Topics: Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Asthenia; Carcino | 2007 |
13 other studies available for thalidomide and Invasiveness, Neoplasm
| Article | Year |
|---|---|
Treatment of aggressive pituitary tumours and carcinomas: results of a European Society of Endocrinology (ESE) survey 2016.
Topics: Adenoma; Adolescent; Adult; Aged; Antineoplastic Agents, Alkylating; Antineoplastic Combined Chemoth | 2018 |
Microvesicles shed from bortezomib-treated or lenalidomide-treated human myeloma cells inhibit angiogenesis in vitro.
Topics: Bortezomib; Cell Line, Tumor; Cell Movement; Cell-Derived Microparticles; Coculture Techniques; Down | 2018 |
Synergistic effects of gefitinib and thalidomide treatment on EGFR-TKI-sensitive and -resistant NSCLC.
Topics: Antineoplastic Agents; Apoptosis; Carcinoma, Non-Small-Cell Lung; Caspases; Cell Cycle; Cell Line, T | 2019 |
Testicular invading refractory multiple myeloma during bortezomib treatment successfully treated with lenalidomide: a case report.
Topics: Angiogenesis Inhibitors; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Boro | 2014 |
Thalidomide inhibits leukemia cell invasion and migration by upregulation of early growth response gene 1.
Topics: Cell Movement; Early Growth Response Protein 1; Gene Expression Regulation, Neoplastic; HL-60 Cells; | 2009 |
Inhibition of metastatic potential in colorectal carcinoma in vivo and in vitro using immunomodulatory drugs (IMiDs).
Topics: Animals; Antineoplastic Agents; Cell Movement; Cell Proliferation; Colorectal Neoplasms; Cytokines; | 2009 |
Triptolide, histone acetyltransferase inhibitor, suppresses growth and chemosensitizes leukemic cells through inhibition of gene expression regulated by TNF-TNFR1-TRADD-TRAF2-NIK-TAK1-IKK pathway.
Topics: Antineoplastic Agents; Cell Line; Cell Proliferation; Diterpenes; Enzyme Inhibitors; Epoxy Compounds | 2011 |
Can thalidomide be effective to treat plasma cell leptomeningeal infiltration?
Topics: Female; Humans; Meningeal Neoplasms; Middle Aged; Multiple Myeloma; Neoplasm Invasiveness; Plasma Ce | 2003 |
Extramedullary multiple myeloma escapes the effect of thalidomide.
Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Bone Marrow Neoplasms; Dose-Response Relati | 2004 |
[Multiple myeloma of the IgD-lambda type invading CNS].
Topics: Antineoplastic Combined Chemotherapy Protocols; Biomarkers; Dexamethasone; Doxorubicin; Drug Therapy | 2004 |
[A case report of unresectable gallbladder cancer that responded remarkably to the combination of thalidomide, celecoxib, and gemcitabine].
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Celecoxib; Deoxycytidine; Drug Administration | 2006 |
A novel anticancer effect of thalidomide: inhibition of intercellular adhesion molecule-1-mediated cell invasion and metastasis through suppression of nuclear factor-kappaB.
Topics: Adenocarcinoma; Administration, Oral; Animals; Antineoplastic Agents; Cell Line, Tumor; Cell Prolife | 2006 |
Esophageal atypical carcinoid tumor with tracheal invasion.
Topics: Administration, Oral; Aged; Carcinoid Tumor; Combined Modality Therapy; Diagnosis, Differential; Eso | 2007 |