Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM).

• Status: Not yet recruiting
• Trial end date: 2029-12-29
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene
• Treatments: Antibodies, Monoclonal; BB 1101; Bortezomib; Daratumumab; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

Participant is ≥ 18 years of age

Participant has documented diagnosis of multiple myeloma (MM) and measurable disease:

1. M-protein quantities ≥ 1 g/dL by serum protein electrophoresis (sPEP) or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP); or

2. Light chain MM without measurable disease in serum or urine: serum free light chain (FLC) levels ≥ 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio

Participant has received 1 to 2 prior lines of anti-myeloma therapy.

Participant achieved a response (partial response [PR] or better) to at least 1 prior anti-myeloma regimen.

Participant must have documented disease progression during or after their last anti-myeloma regimen.

Prior treatment with CD38-directed therapy is permitted only if all the following are fulfilled:

1. Best response achieved during CD38-directed therapy was ≥ PR.

2. Participant did not progress while receiving CD38-directed therapy or within 60 days of last dose of therapy.

3. Participant did not discontinue CD38-directed therapy due to a related AE.

4. Last dose of daratumumab was ≥ 3 months prior to randomization.

Prior treatment with bortezomib therapy is permitted, if all the following are fulfilled:

1. Best response achieved during bortezomib therapy was at least a minimal response (MR).

2. Participant did not progress while receiving bortezomib therapy or within 60 days of last dose of therapy

Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

Exclusion Criteria:

Participant has any of the following laboratory abnormalities:

1. Absolute neutrophil count (ANC) < 1,000/µL.

2. Platelet count: < 75,000/µL for participants in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 50,000/µL for participants in whom ≥ 50% of bone marrow nucleated cells are plasma cells

3. Hemoglobin < 8 g/dL (< 4.9 mmol/L).

4. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 or requiring dialysis.

5. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L).

6. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN).

7. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for participants with documented Gilbert's syndrome.

Participant has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.

Participant has peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain.

Participant has prior history of malignancies, other than MM.

Participant with known central nervous system involvement with MM.