A PHASE 3, TWO-STAGE, RANDOMIZED, MULTICENTER, OPEN-LABEL STUDY COMPARING IBERDOMIDE, DARATUMUMAB AND DEXAMETHASONE (IberDd) VERSUS DARATUMUMAB, BORTEZOMIB, AND DEXAMETHASONE (DVd) IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) (EXCALIBER-RRMM)
- Conditions
- Relapsed or refractory multiple myeloma (RRMM)
- Registration Number
- JPRN-jRCT2051210043
- Lead Sponsor
- Hayakawa Jin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
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.
1. Any of the following laboratory abnormalities:
a. Absolute neutrophil count (ANC) < 1,000/microL. It is not permissible to administer granulocyte colony-stimulating factor (GCSF) to achieve minimum ANC levels
b. Platelet count: < 75,000/microL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 50,000/microL for subjects in whom >= 50% of bone marrow nucleated cells are plasma cells. It is not permissible to transfuse subjects to achieve minimum platelet counts
c. Hemoglobin < 8g/dL (< 4.9mmol/L)
d. Estimated glomerular filtration rate (eGFR) < 30mL/min/1.73m^2 or requiring dialysis. The eGFR can be calculated using the modified diet in renal disease (MDRD) formula
e. Corrected serum calcium > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS);<br>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 Outcome Measures
Name Time Method