thalidomide and Leukocytopenia
thalidomide has been researched along with Leukocytopenia in 20 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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.
Research Excerpts
Excerpt | Relevance | Reference |
---|---|---|
"Pomalidomide in combination with dexamethasone has demonstrated positive results in patients with relapsed or refractory multiple myeloma (RRMM), but no data are available in China." | 9.51 | Efficacy and safety of pomalidomide and low-dose dexamethasone in Chinese patients with relapsed or refractory multiple myeloma: a multicenter, prospective, single-arm, phase 2 trial. ( Bai, H; Fang, BJ; Fu, WJ; Liao, AJ; Lu, J; Niu, T; Wang, YF; Zhao, HG, 2022) |
" We report a phase 1 study (NCT01241292) in which we evaluated the safety, efficacy and pharmacokinetics of elotuzumab combined with lenalidomide and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma (RRMM)." | 9.24 | Elotuzumab with lenalidomide and dexamethasone for Japanese patients with relapsed/refractory multiple myeloma: phase 1 study. ( Bleickardt, E; Chou, T; Iida, S; Kinoshita, G; Miyoshi, M; Nagai, H; Pandya, D; Robbins, M, 2017) |
"We report the first clinical investigation conducted in Japan to confirm the safety, tolerability, and pharmacokinetics of ixazomib alone and combined with lenalidomide-dexamethasone (Rd) in Japanese patients with relapsed/refractory multiple myeloma." | 9.24 | Phase 1 study of ixazomib alone or combined with lenalidomide-dexamethasone in Japanese patients with relapsed/refractory multiple myeloma. ( Chou, T; Handa, H; Ishizawa, K; Kase, Y; Suzuki, K; Takubo, T, 2017) |
"We report the results of a non-randomized phase II study of low-dose thalidomide plus low-dose dexamethasone therapy in 66 patients with refractory multiple myeloma." | 9.12 | Low-dose thalidomide plus low-dose dexamethasone therapy in patients with refractory multiple myeloma. ( Abe, M; Fujii, H; Fukuhara, T; Handa, H; Hata, H; Iida, S; Ishida, T; Ishii, A; Ishikawa, T; Kosaka, M; Miyata, A; Murakami, H; Oota, M; Ozaki, S; Sakai, A; Sawamura, M; Shimazaki, C; Shimizu, K; Takagi, T; Takatsuki, K; Wakayama, T, 2007) |
"Thalidomide is effective in treating refractory and relapsed multiple myeloma (MM)." | 9.12 | [Efficacy of thalidomide combined dexamethasone on newly diagnosed multiple myeloma]. ( Chen, YB; Fu, WJ; Hou, J; Wang, DX; Xi, H; Yuan, ZG, 2007) |
"Objective To evaluate the safety profile of ixazomib combined with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) in clinical practice in Japan through an all-case post-marketing surveillance." | 8.12 | Safety Profile of Ixazomib in Patients with Relapsed/Refractory Multiple Myeloma in Japan: An All-case Post-marketing Surveillance. ( Chou, T; Hashimoto, M; Hiraizumi, M; Hoshino, M; Kakimoto, Y; Shimizu, K, 2022) |
"We studied the efficacy and safety of bortezomib (BOR) for treatment of multiple myeloma in comparison with thalidomide (THAL) by reference to adverse events, and searched for laboratory markers that could be used for prognostication of patients." | 7.77 | Clinical assessment of bortezomib for multiple myeloma in comparison with thalidomide. ( Akiba, T; Aotsuka, N; Matsuura, Y; Oguro, R; Satoh, M; Takada, K; Tani, Y; Wakita, H; Yamanaka, C, 2011) |
"In an open study, oral administration of thalidomide to 7 female patients with classic or definite rheumatoid arthritis, in doses ranging from 6." | 7.67 | Thalidomide. A promising new treatment for rheumatoid arthritis. ( Gutiérrez-Rodríguez, O, 1984) |
" A total of 43 patients were recruited into three CPT plus thalidomide cohorts based on CPT dosage in sequence: 5 mg/kg (n = 11), 8 mg/kg (n = 17), and 10 mg/kg (n = 15)." | 6.79 | A multicenter, open-label phase II study of recombinant CPT (Circularly Permuted TRAIL) plus thalidomide in patients with relapsed and refractory multiple myeloma. ( Chen, WM; Geng, C; Hou, J; Huang, Z; Ke, X; Liu, Y; Qiu, L; Wang, F; Wang, Z; Wei, N; Wei, P; Xi, H; Yang, S; Zhao, Y; Zheng, X; Zhu, B, 2014) |
"Pomalidomide in combination with dexamethasone has demonstrated positive results in patients with relapsed or refractory multiple myeloma (RRMM), but no data are available in China." | 5.51 | Efficacy and safety of pomalidomide and low-dose dexamethasone in Chinese patients with relapsed or refractory multiple myeloma: a multicenter, prospective, single-arm, phase 2 trial. ( Bai, H; Fang, BJ; Fu, WJ; Liao, AJ; Lu, J; Niu, T; Wang, YF; Zhao, HG, 2022) |
"Lenalidomide was given at a dose of 15 mg (n=4), or 25 mg (n=20), orally once daily on day 1 to day 1 every 28 days, with (n=20) or without (n=4) DHAP." | 5.36 | Lenalidomide as salvage therapy after allo-SCT for multiple myeloma is effective and leads to an increase of activated NK (NKp44(+)) and T (HLA-DR(+)) cells. ( Atanackovic, D; Ayuk, F; Bacher, U; Badbaran, A; Blaise, D; El-Cheikh, J; Fehse, B; Hildebrandt, Y; Hoffmann, F; Kröger, N; Lioznov, M; Mohty, M; Schilling, G; Wolschke, C; Zander, AR, 2010) |
" We report a phase 1 study (NCT01241292) in which we evaluated the safety, efficacy and pharmacokinetics of elotuzumab combined with lenalidomide and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma (RRMM)." | 5.24 | Elotuzumab with lenalidomide and dexamethasone for Japanese patients with relapsed/refractory multiple myeloma: phase 1 study. ( Bleickardt, E; Chou, T; Iida, S; Kinoshita, G; Miyoshi, M; Nagai, H; Pandya, D; Robbins, M, 2017) |
"We report the first clinical investigation conducted in Japan to confirm the safety, tolerability, and pharmacokinetics of ixazomib alone and combined with lenalidomide-dexamethasone (Rd) in Japanese patients with relapsed/refractory multiple myeloma." | 5.24 | Phase 1 study of ixazomib alone or combined with lenalidomide-dexamethasone in Japanese patients with relapsed/refractory multiple myeloma. ( Chou, T; Handa, H; Ishizawa, K; Kase, Y; Suzuki, K; Takubo, T, 2017) |
"Twenty-one patients with multiple myeloma, all relapsed after frontline autologous stem cell transplantation and all relapsed again after or resistant to thalidomide (employed as second line treatment) received bortezomib (1." | 5.12 | Bortezomib (Velcade) for progressive myeloma after autologous stem cell transplantation and thalidomide. ( Balleari, E; Boccadoro, M; Bodenizza, C; Carella, AM; Cascavilla, N; Catalano, L; Cavallo, F; Dell'Olio, M; Falcone, A; Greco, MM; Guglielmelli, T; La Sala, A; Mantuano, S; Melillo, L; Merla, E; Musto, P; Nobile, M; Palumbo, A; Sanpaolo, G; Scalzulli, PR; Spriano, M; Zambello, R, 2006) |
"We report the results of a non-randomized phase II study of low-dose thalidomide plus low-dose dexamethasone therapy in 66 patients with refractory multiple myeloma." | 5.12 | Low-dose thalidomide plus low-dose dexamethasone therapy in patients with refractory multiple myeloma. ( Abe, M; Fujii, H; Fukuhara, T; Handa, H; Hata, H; Iida, S; Ishida, T; Ishii, A; Ishikawa, T; Kosaka, M; Miyata, A; Murakami, H; Oota, M; Ozaki, S; Sakai, A; Sawamura, M; Shimazaki, C; Shimizu, K; Takagi, T; Takatsuki, K; Wakayama, T, 2007) |
"Thalidomide is effective in treating refractory and relapsed multiple myeloma (MM)." | 5.12 | [Efficacy of thalidomide combined dexamethasone on newly diagnosed multiple myeloma]. ( Chen, YB; Fu, WJ; Hou, J; Wang, DX; Xi, H; Yuan, ZG, 2007) |
"Objective To evaluate the safety profile of ixazomib combined with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) in clinical practice in Japan through an all-case post-marketing surveillance." | 4.12 | Safety Profile of Ixazomib in Patients with Relapsed/Refractory Multiple Myeloma in Japan: An All-case Post-marketing Surveillance. ( Chou, T; Hashimoto, M; Hiraizumi, M; Hoshino, M; Kakimoto, Y; Shimizu, K, 2022) |
"We studied the efficacy and safety of bortezomib (BOR) for treatment of multiple myeloma in comparison with thalidomide (THAL) by reference to adverse events, and searched for laboratory markers that could be used for prognostication of patients." | 3.77 | Clinical assessment of bortezomib for multiple myeloma in comparison with thalidomide. ( Akiba, T; Aotsuka, N; Matsuura, Y; Oguro, R; Satoh, M; Takada, K; Tani, Y; Wakita, H; Yamanaka, C, 2011) |
"In an open study, oral administration of thalidomide to 7 female patients with classic or definite rheumatoid arthritis, in doses ranging from 6." | 3.67 | Thalidomide. A promising new treatment for rheumatoid arthritis. ( Gutiérrez-Rodríguez, O, 1984) |
" The maximum tolerated dose (MTD) of lenalidomide given in combination with gemcitabine was defined as the highest dose level at which no more than one out of four (25%) subjects experiences a dose-limiting toxicity (DLT)." | 2.80 | A phase I dose-escalation study of lenalidomide in combination with gemcitabine in patients with advanced pancreatic cancer. ( Liljefors, M; Rossmann, E; Ullenhag, GJ, 2015) |
" A total of 43 patients were recruited into three CPT plus thalidomide cohorts based on CPT dosage in sequence: 5 mg/kg (n = 11), 8 mg/kg (n = 17), and 10 mg/kg (n = 15)." | 2.79 | A multicenter, open-label phase II study of recombinant CPT (Circularly Permuted TRAIL) plus thalidomide in patients with relapsed and refractory multiple myeloma. ( Chen, WM; Geng, C; Hou, J; Huang, Z; Ke, X; Liu, Y; Qiu, L; Wang, F; Wang, Z; Wei, N; Wei, P; Xi, H; Yang, S; Zhao, Y; Zheng, X; Zhu, B, 2014) |
"Capecitabine was administered orally twice a day at a dose of 1, 250 mg/m(2) for 14-day followed by 7-day rest and oral thalidomide 100 mg was given daily without interruption until disease progression or occurrence of unacceptable toxicity." | 2.78 | [Effect of second-line treatment with capecitabine and thalidomide in patients with advanced pancreatic cancer]. ( Li, CH; Ma, TH; Shi, SB; Tang, XY, 2013) |
"Oral lenalidomide 25 mg was self-administered once daily on days 1-21 every 28 d for up to 52 weeks, according to tolerability or until disease progression." | 2.74 | Lenalidomide oral monotherapy produces a high response rate in patients with relapsed or refractory mantle cell lymphoma. ( Ervin-Haynes, A; Habermann, TM; Justice, G; Lossos, IS; McBride, K; Pietronigro, D; Takeshita, K; Tuscano, JM; Vose, JM; Wiernik, PH; Wride, K; Zeldis, JB, 2009) |
"NP regimen combined with thalidomide can significantly prolong the median time to tumor progression in patients with advanced NSCLC." | 2.74 | [Randomized study of thalidomide combined with vinorelbine and cisplatin chemotherapy for the treatment of advanced non-small cell lung cancer]. ( Gu, AQ; Han, BH; Qi, DJ; Shen, J; Song, YY; Xin, Y; Xiong, LW; Zhang, XY, 2009) |
"Thalidomide was administered together with current therapy to 63 patients, starting at 50 mg daily and increasing to 400 mg as tolerated." | 2.71 | Low-dose thalidomide ameliorates cytopenias and splenomegaly in myelofibrosis with myeloid metaplasia: a phase II trial. ( Balestri, F; Barosi, G; Barulli, S; Bauduer, F; Bendotti, C; Bordessoule, D; Broccia, G; Buccisano, F; Caenazzo, A; Demory, JL; Dupriez, B; Falcone, A; Gentili, S; Grossi, A; Ilariucci, F; Le Bousse-Kerdiles, MC; Marchetti, M; Pecci, A; Viarengo, G; Volpe, A, 2004) |
"Lenalidomide was given at a dose of 15 mg (n=4), or 25 mg (n=20), orally once daily on day 1 to day 1 every 28 days, with (n=20) or without (n=4) DHAP." | 1.36 | Lenalidomide as salvage therapy after allo-SCT for multiple myeloma is effective and leads to an increase of activated NK (NKp44(+)) and T (HLA-DR(+)) cells. ( Atanackovic, D; Ayuk, F; Bacher, U; Badbaran, A; Blaise, D; El-Cheikh, J; Fehse, B; Hildebrandt, Y; Hoffmann, F; Kröger, N; Lioznov, M; Mohty, M; Schilling, G; Wolschke, C; Zander, AR, 2010) |
Research
Studies (20)
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 2 (10.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 7 (35.00) | 29.6817 |
2010's | 8 (40.00) | 24.3611 |
2020's | 3 (15.00) | 2.80 |
Authors
Authors | Studies |
---|---|
Kakimoto, Y | 1 |
Hoshino, M | 1 |
Hashimoto, M | 1 |
Hiraizumi, M | 1 |
Shimizu, K | 2 |
Chou, T | 3 |
Fu, WJ | 2 |
Wang, YF | 1 |
Zhao, HG | 1 |
Niu, T | 1 |
Fang, BJ | 1 |
Liao, AJ | 1 |
Bai, H | 1 |
Lu, J | 1 |
Zhou, X | 1 |
Steinhardt, MJ | 1 |
Grathwohl, D | 1 |
Meckel, K | 1 |
Nickel, K | 1 |
Leicht, HB | 1 |
Krummenast, F | 1 |
Einsele, H | 1 |
Rasche, L | 1 |
Kortüm, KM | 1 |
Burgstaller, S | 1 |
Fridrik, M | 1 |
Hojas, S | 1 |
Kühr, T | 1 |
Ludwig, H | 1 |
Mayrbäurl, B | 1 |
Pöhnl, R | 1 |
Pötscher, M | 1 |
Schlögl, E | 1 |
Zauner, D | 1 |
Thaler, J | 1 |
Gisslinger, H | 1 |
Shi, SB | 1 |
Ma, TH | 1 |
Tang, XY | 1 |
Li, CH | 1 |
Geng, C | 1 |
Hou, J | 2 |
Zhao, Y | 1 |
Ke, X | 1 |
Wang, Z | 1 |
Qiu, L | 1 |
Xi, H | 2 |
Wang, F | 1 |
Wei, N | 1 |
Liu, Y | 1 |
Yang, S | 1 |
Wei, P | 1 |
Zheng, X | 1 |
Huang, Z | 1 |
Zhu, B | 1 |
Chen, WM | 1 |
Ullenhag, GJ | 1 |
Rossmann, E | 1 |
Liljefors, M | 1 |
Iida, S | 2 |
Nagai, H | 1 |
Kinoshita, G | 1 |
Miyoshi, M | 1 |
Robbins, M | 1 |
Pandya, D | 1 |
Bleickardt, E | 1 |
Suzuki, K | 1 |
Handa, H | 2 |
Ishizawa, K | 1 |
Takubo, T | 1 |
Kase, Y | 1 |
Habermann, TM | 1 |
Lossos, IS | 1 |
Justice, G | 1 |
Vose, JM | 1 |
Wiernik, PH | 1 |
McBride, K | 1 |
Wride, K | 1 |
Ervin-Haynes, A | 1 |
Takeshita, K | 1 |
Pietronigro, D | 1 |
Zeldis, JB | 1 |
Tuscano, JM | 1 |
Lioznov, M | 1 |
El-Cheikh, J | 1 |
Hoffmann, F | 1 |
Hildebrandt, Y | 1 |
Ayuk, F | 1 |
Wolschke, C | 1 |
Atanackovic, D | 1 |
Schilling, G | 1 |
Badbaran, A | 1 |
Bacher, U | 1 |
Fehse, B | 1 |
Zander, AR | 1 |
Blaise, D | 1 |
Mohty, M | 1 |
Kröger, N | 1 |
Gu, AQ | 1 |
Han, BH | 1 |
Zhang, XY | 1 |
Shen, J | 1 |
Qi, DJ | 1 |
Xiong, LW | 1 |
Xin, Y | 1 |
Song, YY | 1 |
Satoh, M | 1 |
Oguro, R | 1 |
Yamanaka, C | 1 |
Takada, K | 1 |
Matsuura, Y | 1 |
Akiba, T | 1 |
Aotsuka, N | 1 |
Tani, Y | 1 |
Wakita, H | 1 |
Friedman, L | 1 |
Shue, GM | 1 |
Hove, EL | 1 |
Marchetti, M | 1 |
Barosi, G | 1 |
Balestri, F | 1 |
Viarengo, G | 1 |
Gentili, S | 1 |
Barulli, S | 1 |
Demory, JL | 1 |
Ilariucci, F | 1 |
Volpe, A | 1 |
Bordessoule, D | 1 |
Grossi, A | 1 |
Le Bousse-Kerdiles, MC | 1 |
Caenazzo, A | 1 |
Pecci, A | 1 |
Falcone, A | 2 |
Broccia, G | 1 |
Bendotti, C | 1 |
Bauduer, F | 1 |
Buccisano, F | 1 |
Dupriez, B | 1 |
Musto, P | 1 |
Sanpaolo, G | 1 |
Guglielmelli, T | 1 |
Zambello, R | 1 |
Balleari, E | 1 |
Catalano, L | 1 |
Spriano, M | 1 |
Cavallo, F | 1 |
La Sala, A | 1 |
Mantuano, S | 1 |
Nobile, M | 1 |
Melillo, L | 1 |
Scalzulli, PR | 1 |
Dell'Olio, M | 1 |
Bodenizza, C | 1 |
Greco, MM | 1 |
Carella, AM | 2 |
Merla, E | 1 |
Boccadoro, M | 1 |
Cascavilla, N | 1 |
Palumbo, A | 1 |
Murakami, H | 1 |
Abe, M | 1 |
Ishii, A | 1 |
Ishikawa, T | 1 |
Ishida, T | 1 |
Oota, M | 1 |
Ozaki, S | 1 |
Kosaka, M | 1 |
Sakai, A | 1 |
Sawamura, M | 1 |
Shimazaki, C | 1 |
Takagi, T | 1 |
Hata, H | 1 |
Fukuhara, T | 1 |
Fujii, H | 1 |
Miyata, A | 1 |
Wakayama, T | 1 |
Takatsuki, K | 1 |
Yuan, ZG | 1 |
Wang, DX | 1 |
Chen, YB | 1 |
Gutiérrez-Rodríguez, O | 1 |
Clinical Trials (4)
Trial Overview
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Phase I/II Study of Lenalidomide and Gemcitabine as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Cancer[NCT01547260] | Phase 1/Phase 2 | 34 participants (Actual) | Interventional | 2009-10-31 | Completed | ||
Phase 1 Multiple Ascending Dose Study of Elotuzumab (BMS-901608) in Combination With Lenalidomide/Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma in Japan[NCT01241292] | Phase 1 | 7 participants (Actual) | Interventional | 2011-01-14 | Completed | ||
Phase Ib Dose Finding Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma (MCL)[NCT02446236] | Phase 1 | 27 participants (Actual) | Interventional | 2015-06-18 | Active, not recruiting | ||
Safety and Efficacy Assessments of Osalmid in the Treatment of Multiple Myeloma[NCT03670173] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2018-10-01 | Active, not recruiting | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial Outcomes
Number of Participants Positive for Anti-Elotuzumab Anti-drug Antibodies - Treated Participants
The detection of anti-elotuzumab anti-drug antibodies (ADAs) in human serum was performed using a validated bridging electrochemiluminescence immunoassay (ECLA) on the Meso Scale Discovery (MSD) platform. Sample collection was performed prior to administration of elotuzumab at Day 1 of each cycle. (NCT01241292)
Timeframe: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Intervention | participants (Number) |
---|---|
Elotuzumab 10 mg/kg | 3 |
Elotuzumab 20 mg/kg | 0 |
Number of Participants With Clinically Relevant Vital Sign Findings
Vital signs (body temperature, seated blood pressure, heart rate, and respiration rate) were recorded at screening on Days 1, 8, 15, and 22 of Cycles 1 and 2, on Days 1 and 15 of Cycle 3, and at the end of treatment. Blood pressure (Diastolic and Systolic) and heart rate were recorded after the participant sat quietly for at least 5 minutes. Clinical relevance of vital sign data was determined by the investigator. (NCT01241292)
Timeframe: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Intervention | participants (Number) |
---|---|
Elotuzumab 10 mg/kg | 0 |
Elotuzumab 20 mg/kg | 0 |
Geometric Mean Maximum Observed Serum Elotuzumab Concentration (Cmax) During Cycles 1, 2, and 3
The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h. (NCT01241292)
Timeframe: Days 1, 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3
Intervention | µg/mL (Geometric Mean) | ||||||
---|---|---|---|---|---|---|---|
Cycle 1 Day 1 (n=3,3) | Cycle 1 Day 8 (n=3,3) | Cycle 1 Day 15 (n=3,3) | Cycle 1 Day 22 (n=3,2) | Cycle 2 Day 1 (n=3,3) | Cycle 2 Day 22 (n=3,3) | Cycle 3 Day 1 (n=3,3) | |
Elotuzumab 10 mg/kg | 173 | 237 | 297 | 234 | 240 | 270 | 286 |
Elotuzumab 20 mg/kg | 376 | 549 | 652 | 724 | 671 | 844 | 972 |
Geometric Mean Minimum Observed Serum Elotuzumab Concentration (Cmin) During Cycles 1, 2, and 3
The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmin was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h. (NCT01241292)
Timeframe: Days 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3
Intervention | µg/mL (Geometric Mean) | ||||||
---|---|---|---|---|---|---|---|
Cycle 1 Day 8 (n=3,3) | Cycle 1 Day 15 (n=3,3) | Cycle 1 Day 22 (n=3,2) | Cycle 2 Day 1 (n=3,2) | Cycle 2 Day 22 (n=3,3) | Cycle 3 Day 1 (n=3,3) | Cycle 3 Day 15 (n=3,3) | |
Elotuzumab 10 mg/kg | 59.1 | 97.0 | 24.6 | 25.8 | 57.8 | 77.2 | 59.4 |
Elotuzumab 20 mg/kg | 165 | 252 | 280 | 389 | 547 | 579 | 466 |
Number of Participants With Best Overall Response - Treated Participants
Complete response (CR) and Partial Response (PR) were based on the European Group for Blood and Bone Marrow Transplant (EBMT) Criteria. Very Good Partial response was derived from the International Myeloma Working Group (IMWG) criteria. Participants who had a reduction in M-protein or plasmacytoma but did not meet the EBMT criteria for PR were classified as minimal response (MR). Hematologic, radiologic and/or clinical assessments were done every cycle starting with cycle 2. Each cycle is 4 weeks in length (Day 1, Day 8, Day 15, Day 22). Cycle 2 began on study Day 29. CR=negative immunofixation 6 weeks, <5% plasma cells, no increase in size or number of lytic lesions, complete disappearance of extramedullary plasmacytoma. PR=≥50%reduction in M-protein for 6 weeks, ≥90% reduction of urinary light chain excretion or < 200 mg/24hours for 6 weeks, ≥50% reduction in size of extramedullary plasmacytoma present at baseline, no increase in size or number of lytic lesions. (NCT01241292)
Timeframe: Cycle 2 (Study Day 29) to last dose (assessed up to January 2017, approximately 71 months)
Intervention | participants (Number) | |||
---|---|---|---|---|
Complete Response | Very Good Partial Response | Partial Response | Minimal Response | |
Elotuzumab 10 mg/kg | 0 | 1 | 1 | 1 |
Elotuzumab 20 mg/kg | 1 | 2 | 0 | 0 |
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Data cut-off February 2014. (NCT01241292)
Timeframe: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
All SAEs Any Grade | Grade 3-4 SAEs | AEs Leading to Discontinuation | Grade 3-4 AEs | Deaths | |
Elotuzumab 10 mg/kg | 2 | 1 | 0 | 3 | 0 |
Elotuzumab 20 mg/kg | 3 | 3 | 1 | 3 | 0 |
Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests
NCI CTCAE, version 3.0 was used to measure toxicity scale. Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 - 155; Gr 3: >155 - 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:
Timeframe: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Intervention | participants (Number) | |||||||
---|---|---|---|---|---|---|---|---|
Potassium High, Any Grade | Potassium High, Grade 3-4 | Potassium Low, Any Grade | Potassium Low, Grade 3-4 | Sodium High, Any Grade | Sodium High, Grade 3-4 | Sodium Low, Any Grade | Sodium Low, Grade 3-4 | |
Elotuzumab 10 mg/kg | 0 | 0 | 3 | 0 | 1 | 0 | 2 | 0 |
Elotuzumab 20 mg/kg | 2 | 0 | 2 | 1 | 2 | 0 | 3 | 0 |
Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:
Timeframe: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Intervention | participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Hemoglobin Any Grade | Hemoglobin Grade 3-4 | Lymphocytes Any Grade | Lymphocytes Grade 3-4 | Neutrophils Any Grade | Neutrophils Grade 3-4 | Platelet Count Any Grade | Platelet Count Grade 3-4 | Leukocytes Any Grade | Leukocytes Grade 3-4 | |
Elotuzumab 10 mg/kg | 3 | 0 | 3 | 3 | 3 | 2 | 3 | 1 | 3 | 2 |
Elotuzumab 20 mg/kg | 3 | 1 | 3 | 3 | 3 | 3 | 2 | 0 | 3 | 1 |
Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:
Timeframe: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Intervention | participants (Number) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Albumin Any Grade | Albumin Grade 3-4 | ALP Any Grade | ALP Grade 3-4 | ALT Any Grade | ALT Grade 3-4 | AST Any Grade | AST Grade 3-4 | Creatinine Any Grade | Creatinine Grade 3-4 | Bilirubin Total Any Grade | Bilirubin Total Grade 3-4 | |
Elotuzumab 10 mg/kg | 3 | 0 | 1 | 0 | 2 | 1 | 1 | 1 | 0 | 0 | 1 | 0 |
Elotuzumab 20 mg/kg | 3 | 0 | 2 | 0 | 2 | 1 | 2 | 1 | 2 | 0 | 0 | 0 |
Trials
12 trials available for thalidomide and Leukocytopenia
Article | Year |
---|---|
Efficacy and safety of pomalidomide and low-dose dexamethasone in Chinese patients with relapsed or refractory multiple myeloma: a multicenter, prospective, single-arm, phase 2 trial.
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; Lenalidomide; Leukopen | 2022 |
[Effect of second-line treatment with capecitabine and thalidomide in patients with advanced pancreatic cancer].
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Capecitabine; Deoxycytidine; Diarrhea; | 2013 |
A multicenter, open-label phase II study of recombinant CPT (Circularly Permuted TRAIL) plus thalidomide in patients with relapsed and refractory multiple myeloma.
Topics: Adult; Aged; Alanine Transaminase; Antineoplastic Combined Chemotherapy Protocols; Aspartate Aminotr | 2014 |
A phase I dose-escalation study of lenalidomide in combination with gemcitabine in patients with advanced pancreatic cancer.
Topics: Adenocarcinoma; Administration, Oral; Aged; Anticoagulants; Antineoplastic Combined Chemotherapy Pro | 2015 |
Elotuzumab with lenalidomide and dexamethasone for Japanese patients with relapsed/refractory multiple myeloma: phase 1 study.
Topics: Aged; Antibodies, Monoclonal, Humanized; Dexamethasone; Drug Therapy, Combination; Female; Humans; L | 2017 |
Phase 1 study of ixazomib alone or combined with lenalidomide-dexamethasone in Japanese patients with relapsed/refractory multiple myeloma.
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Asian People; Boron Compounds; Dexamethasone; | 2017 |
Lenalidomide oral monotherapy produces a high response rate in patients with relapsed or refractory mantle cell lymphoma.
Topics: Administration, Oral; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; Drug Ad | 2009 |
[Randomized study of thalidomide combined with vinorelbine and cisplatin chemotherapy for the treatment of advanced non-small cell lung cancer].
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Cisplat | 2009 |
Low-dose thalidomide ameliorates cytopenias and splenomegaly in myelofibrosis with myeloid metaplasia: a phase II trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anemia; Female; Humans; Immunosuppressive Agents; Leukop | 2004 |
Bortezomib (Velcade) for progressive myeloma after autologous stem cell transplantation and thalidomide.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antineoplastic Agents; Boronic Acids; Bortezomib; Female; Huma | 2006 |
Low-dose thalidomide plus low-dose dexamethasone therapy in patients with refractory multiple myeloma.
Topics: Adult; Aged; Dexamethasone; Dose-Response Relationship, Drug; Female; Humans; Leukopenia; Male; Midd | 2007 |
[Efficacy of thalidomide combined dexamethasone on newly diagnosed multiple myeloma].
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Constipation; Cytara | 2007 |
Other Studies
8 other studies available for thalidomide and Leukocytopenia
Article | Year |
---|---|
Safety Profile of Ixazomib in Patients with Relapsed/Refractory Multiple Myeloma in Japan: An All-case Post-marketing Surveillance.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boron Compounds; Dex | 2022 |
Multiagent therapy with pomalidomide, bortezomib, doxorubicin, dexamethasone, and daratumumab ("Pom-PAD-Dara") in relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy | 2020 |
Experience with lenalidomide in an Austrian non-study population with advanced myelofibrosis.
Topics: Aged; Aged, 80 and over; Anemia; Austria; Dose-Response Relationship, Drug; Female; Humans; Immunolo | 2013 |
Lenalidomide as salvage therapy after allo-SCT for multiple myeloma is effective and leads to an increase of activated NK (NKp44(+)) and T (HLA-DR(+)) cells.
Topics: Hematopoietic Stem Cell Transplantation; HLA-DR Antigens; Humans; Killer Cells, Natural; Lenalidomid | 2010 |
Clinical assessment of bortezomib for multiple myeloma in comparison with thalidomide.
Topics: Adult; Aged; Aged, 80 and over; Alkaline Phosphatase; Angiogenesis Inhibitors; Antineoplastic Agents | 2011 |
RESPONSE OF RATS TO THALIDOMIDE AS AFFECTED BY RIBOFLAVIN OR FOLIC ACID DEFICIENCY.
Topics: Amino Acid Oxidoreductases; Avitaminosis; D-Amino-Acid Oxidase; Electron Transport Complex II; Flavi | 1965 |
[Potential side effects of thalidomide].
Topics: Constipation; Disorders of Excessive Somnolence; Drug Eruptions; Humans; Immunosuppressive Agents; L | 2006 |
Thalidomide. A promising new treatment for rheumatoid arthritis.
Topics: Adult; Arthritis, Rheumatoid; Blood Sedimentation; Drug Eruptions; Female; Humans; Leukopenia; Middl | 1984 |