Page last updated: 2024-11-05

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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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

ExcerptRelevanceReference
"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."9.51Efficacy 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)."9.24Elotuzumab 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."9.24Phase 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."9.12Low-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."8.12Safety 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."7.77Clinical 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."7.67Thalidomide. 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)."6.79A 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."5.51Efficacy 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."5.36Lenalidomide 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)."5.24Elotuzumab 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."5.24Phase 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."5.12Bortezomib (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."5.12Low-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."4.12Safety 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."3.77Clinical 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."3.67Thalidomide. 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)."2.80A 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)."2.79A 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."2.74Lenalidomide 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."2.71Low-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."1.36Lenalidomide 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)

TimeframeStudies, this research(%)All Research%
pre-19902 (10.00)18.7374
1990's0 (0.00)18.2507
2000's7 (35.00)29.6817
2010's8 (40.00)24.3611
2020's3 (15.00)2.80

Authors

AuthorsStudies
Kakimoto, Y1
Hoshino, M1
Hashimoto, M1
Hiraizumi, M1
Shimizu, K2
Chou, T3
Fu, WJ2
Wang, YF1
Zhao, HG1
Niu, T1
Fang, BJ1
Liao, AJ1
Bai, H1
Lu, J1
Zhou, X1
Steinhardt, MJ1
Grathwohl, D1
Meckel, K1
Nickel, K1
Leicht, HB1
Krummenast, F1
Einsele, H1
Rasche, L1
Kortüm, KM1
Burgstaller, S1
Fridrik, M1
Hojas, S1
Kühr, T1
Ludwig, H1
Mayrbäurl, B1
Pöhnl, R1
Pötscher, M1
Schlögl, E1
Zauner, D1
Thaler, J1
Gisslinger, H1
Shi, SB1
Ma, TH1
Tang, XY1
Li, CH1
Geng, C1
Hou, J2
Zhao, Y1
Ke, X1
Wang, Z1
Qiu, L1
Xi, H2
Wang, F1
Wei, N1
Liu, Y1
Yang, S1
Wei, P1
Zheng, X1
Huang, Z1
Zhu, B1
Chen, WM1
Ullenhag, GJ1
Rossmann, E1
Liljefors, M1
Iida, S2
Nagai, H1
Kinoshita, G1
Miyoshi, M1
Robbins, M1
Pandya, D1
Bleickardt, E1
Suzuki, K1
Handa, H2
Ishizawa, K1
Takubo, T1
Kase, Y1
Habermann, TM1
Lossos, IS1
Justice, G1
Vose, JM1
Wiernik, PH1
McBride, K1
Wride, K1
Ervin-Haynes, A1
Takeshita, K1
Pietronigro, D1
Zeldis, JB1
Tuscano, JM1
Lioznov, M1
El-Cheikh, J1
Hoffmann, F1
Hildebrandt, Y1
Ayuk, F1
Wolschke, C1
Atanackovic, D1
Schilling, G1
Badbaran, A1
Bacher, U1
Fehse, B1
Zander, AR1
Blaise, D1
Mohty, M1
Kröger, N1
Gu, AQ1
Han, BH1
Zhang, XY1
Shen, J1
Qi, DJ1
Xiong, LW1
Xin, Y1
Song, YY1
Satoh, M1
Oguro, R1
Yamanaka, C1
Takada, K1
Matsuura, Y1
Akiba, T1
Aotsuka, N1
Tani, Y1
Wakita, H1
Friedman, L1
Shue, GM1
Hove, EL1
Marchetti, M1
Barosi, G1
Balestri, F1
Viarengo, G1
Gentili, S1
Barulli, S1
Demory, JL1
Ilariucci, F1
Volpe, A1
Bordessoule, D1
Grossi, A1
Le Bousse-Kerdiles, MC1
Caenazzo, A1
Pecci, A1
Falcone, A2
Broccia, G1
Bendotti, C1
Bauduer, F1
Buccisano, F1
Dupriez, B1
Musto, P1
Sanpaolo, G1
Guglielmelli, T1
Zambello, R1
Balleari, E1
Catalano, L1
Spriano, M1
Cavallo, F1
La Sala, A1
Mantuano, S1
Nobile, M1
Melillo, L1
Scalzulli, PR1
Dell'Olio, M1
Bodenizza, C1
Greco, MM1
Carella, AM2
Merla, E1
Boccadoro, M1
Cascavilla, N1
Palumbo, A1
Murakami, H1
Abe, M1
Ishii, A1
Ishikawa, T1
Ishida, T1
Oota, M1
Ozaki, S1
Kosaka, M1
Sakai, A1
Sawamura, M1
Shimazaki, C1
Takagi, T1
Hata, H1
Fukuhara, T1
Fujii, H1
Miyata, A1
Wakayama, T1
Takatsuki, K1
Yuan, ZG1
Wang, DX1
Chen, YB1
Gutiérrez-Rodríguez, O1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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 234 participants (Actual)Interventional2009-10-31Completed
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 17 participants (Actual)Interventional2011-01-14Completed
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 127 participants (Actual)Interventional2015-06-18Active, not recruiting
Safety and Efficacy Assessments of Osalmid in the Treatment of Multiple Myeloma[NCT03670173]Phase 1/Phase 220 participants (Anticipated)Interventional2018-10-01Active, 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)

Interventionparticipants (Number)
Elotuzumab 10 mg/kg3
Elotuzumab 20 mg/kg0

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)

Interventionparticipants (Number)
Elotuzumab 10 mg/kg0
Elotuzumab 20 mg/kg0

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

,
Interventionµg/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/kg173237297234240270286
Elotuzumab 20 mg/kg376549652724671844972

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

,
Interventionµg/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/kg59.197.024.625.857.877.259.4
Elotuzumab 20 mg/kg165252280389547579466

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)

,
Interventionparticipants (Number)
Complete ResponseVery Good Partial ResponsePartial ResponseMinimal Response
Elotuzumab 10 mg/kg0111
Elotuzumab 20 mg/kg1200

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)

,
Interventionparticipants (Number)
All SAEs Any GradeGrade 3-4 SAEsAEs Leading to DiscontinuationGrade 3-4 AEsDeaths
Elotuzumab 10 mg/kg21030
Elotuzumab 20 mg/kg33130

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:ULN - 5.5; Gr 2: >5.5 - 6.0; Gr 3: > 6.0 - 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1 - Gr 2: NCT01241292)
Timeframe: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)

,
Interventionparticipants (Number)
Potassium High, Any GradePotassium High, Grade 3-4Potassium Low, Any GradePotassium Low, Grade 3-4Sodium High, Any GradeSodium High, Grade 3-4Sodium Low, Any GradeSodium Low, Grade 3-4
Elotuzumab 10 mg/kg00301020
Elotuzumab 20 mg/kg20212030

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:NCT01241292)
Timeframe: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)

,
Interventionparticipants (Number)
Hemoglobin Any GradeHemoglobin Grade 3-4Lymphocytes Any GradeLymphocytes Grade 3-4Neutrophils Any GradeNeutrophils Grade 3-4Platelet Count Any GradePlatelet Count Grade 3-4Leukocytes Any GradeLeukocytes Grade 3-4
Elotuzumab 10 mg/kg3033323132
Elotuzumab 20 mg/kg3133332031

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 1:1 - 1.5*baseline (BL)to >ULN - 1.5*ULN; Gr 2: >1.5 - 3.0*BL to > 1.5 - 3.0*ULN; Gr 3: >3.0*BL to > 3.0 - 6.0*ULN; Gr 4: >6.0*ULN. (NCT01241292)
Timeframe: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)

,
Interventionparticipants (Number)
Albumin Any GradeAlbumin Grade 3-4ALP Any GradeALP Grade 3-4ALT Any GradeALT Grade 3-4AST Any GradeAST Grade 3-4Creatinine Any GradeCreatinine Grade 3-4Bilirubin Total Any GradeBilirubin Total Grade 3-4
Elotuzumab 10 mg/kg301021110010
Elotuzumab 20 mg/kg302021212000

Trials

12 trials available for thalidomide and Leukocytopenia

ArticleYear
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.
    BMC cancer, 2022, Jul-01, Volume: 22, Issue:1

    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].
    Zhonghua zhong liu za zhi [Chinese journal of oncology], 2013, Volume: 35, Issue:4

    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.
    American journal of hematology, 2014, Volume: 89, Issue:11

    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.
    PloS one, 2015, Volume: 10, Issue:4

    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.
    International journal of hematology, 2017, Volume: 105, Issue:3

    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.
    International journal of hematology, 2017, Volume: 105, Issue:4

    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.
    British journal of haematology, 2009, Volume: 145, Issue:3

    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].
    Zhonghua zhong liu za zhi [Chinese journal of oncology], 2009, Volume: 31, Issue:4

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2004, Feb-01, Volume: 22, Issue:3

    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.
    Leukemia research, 2006, Volume: 30, Issue:3

    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.
    European journal of haematology, 2007, Volume: 79, Issue:3

    Topics: Adult; Aged; Dexamethasone; Dose-Response Relationship, Drug; Female; Humans; Leukopenia; Male; Midd

2007
[Efficacy of thalidomide combined dexamethasone on newly diagnosed multiple myeloma].
    Ai zheng = Aizheng = Chinese journal of cancer, 2007, Volume: 26, Issue:12

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Constipation; Cytara

2007

Other Studies

8 other studies available for thalidomide and Leukocytopenia

ArticleYear
Safety Profile of Ixazomib in Patients with Relapsed/Refractory Multiple Myeloma in Japan: An All-case Post-marketing Surveillance.
    Internal medicine (Tokyo, Japan), 2022, May-01, Volume: 61, Issue:9

    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.
    Cancer medicine, 2020, Volume: 9, Issue:16

    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.
    Wiener klinische Wochenschrift, 2013, Volume: 125, Issue:7-8

    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.
    Bone marrow transplantation, 2010, Volume: 45, Issue:2

    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.
    Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques, 2011, Volume: 14, Issue:1

    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.
    The Journal of nutrition, 1965, Volume: 85, Issue:3

    Topics: Amino Acid Oxidoreductases; Avitaminosis; D-Amino-Acid Oxidase; Electron Transport Complex II; Flavi

1965
[Potential side effects of thalidomide].
    La Revue du praticien, 2006, Jan-15, Volume: 56, Issue:1

    Topics: Constipation; Disorders of Excessive Somnolence; Drug Eruptions; Humans; Immunosuppressive Agents; L

2006
Thalidomide. A promising new treatment for rheumatoid arthritis.
    Arthritis and rheumatism, 1984, Volume: 27, Issue:10

    Topics: Adult; Arthritis, Rheumatoid; Blood Sedimentation; Drug Eruptions; Female; Humans; Leukopenia; Middl

1984
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