Isatuximab short duration fixed volume infusion combination therapy for relapsed/refractory multiple myeloma (RRMM): phase 1b feasibility/safety study

2019 ◽  
Vol 19 (10) ◽  
pp. e283 ◽  
Author(s):  
Saad Usmani ◽  
Chatchada Karanes ◽  
William I. Bensinger ◽  
Anita D'Souza ◽  
Noopur Raje ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Combination Therapy ◽  
Short Duration ◽  
Safety Study ◽  
Refractory Multiple Myeloma ◽  
Fixed Volume ◽  
Phase 1B

scholarly journals Final results of a phase 1b study of isatuximab short-duration fixed-volume infusion combination therapy for relapsed/refractory multiple myeloma

Leukemia ◽  
2021 ◽  
Author(s):  
Saad Z. Usmani ◽  
Chatchada Karanes ◽  
William I. Bensinger ◽  
Anita D’Souza ◽  
Noopur Raje ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Median Duration ◽  
Upper Respiratory Tract ◽  
Refractory Multiple Myeloma ◽  
Fixed Volume ◽  
Evaluable Population ◽  
Infusion Reactions ◽  
Phase 1B ◽  
Upper Respiratory ◽  
Infusion Schedule

AbstractPart B of this phase 1b study (ClinicalTrials.gov number, NCT02283775) evaluated safety and efficacy of a fixed-volume infusion of isatuximab, an anti-CD38 monoclonal antibody, in combination with pomalidomide and dexamethasone (Pd) in relapsed/refractory multiple myeloma patients. Isatuximab (10 mg/kg weekly for 4 weeks, then every other week) was administered as a fixed-volume infusion of 250 mL (mL/h infusion rate) with standard doses of Pd on 28-day cycles. Patients (N = 47) had a median of three prior treatment lines (range, 1–8). Median duration of exposure was 36.9 weeks and median duration of first, second, and 3+ infusions were 3.7, 1.8, and 1.2 h, respectively. The most common non-hematologic treatment-emergent adverse events were fatigue (63.8%), infusion reactions (IRs), cough, and upper respiratory tract infection (40.4% each). IRs were all grade 2 and occurred only during the first infusion. The overall response rate was 53.2% in all patients (55.5% in response-evaluable population, 60.0% in daratumumab-naïve patients). Efficacy and safety findings were consistent with data from the isatuximab plus Pd infusion schedule in Part A of this study and also from the phase 3 ICARIA-MM study, and these new data confirm the safety, efficacy, and feasibility of fixed-volume infusion of isatuximab.

scholarly journals Patient Expectations and Perceptions of Treatment in CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma

2021 ◽  
Vol 27 (3) ◽  
pp. S387-S388
Author(s):  
Adam D. Cohen ◽  
Parameswaran Hari ◽  
Myo Htut ◽  
Jesus G. Berdeja ◽  
Deepu Madduri ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Patient Expectations ◽  
Refractory Multiple Myeloma ◽  
Phase 1B

scholarly journals Efficacy of Combination Therapy with Glycyrrhizinate, Antiallergic Agent, and Low Dose Steroid for Lenalidomide-induced Skin Eruptions in a Patient with Refractory Multiple Myeloma

2012 ◽  
Vol 61 (3) ◽  
pp. 89-92
Author(s):  
Masafumi MATSUGUMA ◽  
Toru TAKAHASHI ◽  
Hiroyuki NAKAMURA ◽  
Sumie HIRAMATSU ◽  
Takashi YAMAGUCHI ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Combination Therapy ◽  
Low Dose ◽  
Refractory Multiple Myeloma ◽  
Antiallergic Agent

Ricolinostat plus lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma: a multicentre phase 1b trial

2016 ◽  
Vol 17 (11) ◽  
pp. 1569-1578 ◽  
Author(s):  
Andrew J Yee ◽  
William I Bensinger ◽  
Jeffrey G Supko ◽  
Peter M Voorhees ◽  
Jesus G Berdeja ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Multicentre Phase ◽  
Refractory Multiple Myeloma ◽  
Phase 1B

scholarly journals Weekly carfilzomib, lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma: A phase 1b study

2019 ◽  
Vol 94 (7) ◽  
pp. 794-802 ◽  
Author(s):  
Noa Biran ◽  
David Siegel ◽  
Jesus G. Berdeja ◽  
Noopur Raje ◽  
Robert Frank Cornell ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Refractory Multiple Myeloma ◽  
Phase 1B
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