Relapsed or refractory multiple myeloma (RRMM)
Conditions
Interventions
[IberDd] At the First Stage, Iberdomide (CC-220) 1.0 mg, 1.3 mg or 1.6 mg will be administered orally once daily for 21 consecutive days, followed by a 7-day rest period. This procedure, constituting
Sponsors
Kimura Shunsuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Documented diagnosis of MM and measurable disease, defined as any of the following: a. M-protein quantities >= 1g/dL by serum protein electrophoresis (sPEP) or >= 200mg/24-hour urine collection by urine protein electrophoresis (uPEP); or b. Light chain MM without measurable disease in serum or urine: serum free light chain (FLC) levels > 100mg/L (10mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio 2. Received 1 to 2 prior lines of anti-myeloma therapy 3. Achieved a response (partial response [PR] or better) to at least 1 prior antimyeloma regimen 4. Must have documented disease progression during or after their last antimyeloma regimen 5. In Stage 2, prior treatment with CD38-directed therapy is permitted only if all the following are fulfilled: a. Best response achieved during CD38-directed-containing therapy was > PR b. Subject did not progress while receiving CD38-directed therapy or within 60 days of last dose of therapy c. Subject did not discontinue CD38-directed therapy due to a related AE 6. Prior treatment with bortezomib therapy is permitted, if all the following are fulfilled: a. Best response achieved during bortezomib-containing therapy was at least a minimal response (MR) b. Subject did not progress while receiving bortezomib therapy or within 60 days of last dose of therapy 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Exclusion criteria
Exclusion criteria: 1. Any of the following laboratory abnormalities: a. Absolute neutrophil count (ANC) = 50% of bone marrow nucleated cells are plasma cells. It is not permissible to transfuse subjects to achieve minimum platelet counts c. Hemoglobin 13.5mg/dL (> 3.4mmol/L) f. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5*upper limit of normal (ULN) g. Serum total bilirubin > 1.5*ULN or > 3.0mg/dL for subjects with documented Gilbert's syndrome 2. Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis 3. Known central nervous system involvement with MM 4. Prior therapy with iberdomide 5. Has previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of initiating study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); Time from randomization to the first documentation of progressive disease according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma or death due to any cause, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS); Time from randomization to time of death due to any Cause Overall response rate (ORR); Percentage of subjects who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma Time to response (TTR); Time from randomization to the first documentation of response (PR or better) Duration of response (DoR); Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first Time to progression (TTP); Time from randomization to the first documentation of PD Time to next treatment (TTNT); Time from randomization to the start of the next antimyeloma Treatment Progression-free survival 2 (PFS2); Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first Safety; Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment European Organization for Research and Treatment of Cancer-Quality of Life C30 questionnaire (EORTC QLQ-C30) and European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20); Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30 and the EORTC QLQ-MY20 | — |
Countries
Austlaria, Austria, Belgium, Canada, China, Czech Rep, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UK, US
Contacts
Public ContactShunsuke Kimura
Bristol-Myers Squibb
Outcome results
None listed