A Phase Ib, Multi-center, Study of Talquetamab in Combination With Iberdomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
Alfred Chung, MD
Summary
This phase I trial will evaluate the safety, side effects, and best dose of talquetamab in combination with iberdomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). There is currently a significant unmet need for patients with relapsed or refractory multiple myeloma (RRMM) who are triple class refractory and have been exposed to B-cell maturation antibody (BCMA) targeted therapy. These patients currently have limited treatment options and poor survival. Talquetamab is an FDA approved drug that can bring T-cells to the myeloma cell, resulting in myeloma cell death. Iberdomide is an investigational drug and works by targeting and destroying proteins that help myeloma cancer cells to survive. Dexamethasone is a corticosteroid, is similar to a natural hormone produced by the adrenal glands to reduce inflammation (swelling, heat, redness, and pain) and is used to in helping to treat certain types of cancer including myeloma.
Description
PRIMARY OBJECTIVES: I. To assess safety of the combination of talquetamab (Tal), iberdomide (Iber) and dexamethasone (Dex) in patients with triple class exposed (TCE) RRMM. (Phase 1b-dose escalation (DE)). II. To assess dose limiting toxicity (DLT) and determine the recommended phase 2 dose (RP2D) of the combination of Tal, Iber and Dex administered in 28-day cycles in patients with TCE RRMM. (Phase 1b-DE). III. To further assess safety of RP2D of the combination of Tal, Iber and Dex administered in 28-day cycles in patients with TCE RRMM Len-refractory, and having received \>= 2 prior line…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female ≥ 18 years of age. 2. Has a prior history of (h/o) MM (based on International Myeloma Working Group (IMWG) criteria) and now has evidence of relapsed or refractory MM. RRMM of progressive disease as defined by the IMWG 2006 and 2016 criteria (Kumar at al). 3. Specific criteria for dose escalation and dose expansion: 1. Phase 1 dose escalation: patients will be required to have TCE RRMM (including a proteasome inhibitor (PI) (≥ 2 cycles or 2 months of treatment), an immunomodulatory drug (IMiD)) (≥ 2 cycles or 2 months of treatment) and a CD38 antibody…
Interventions
- BiologicalTalquetamab
Given subcutaneously (SQ)
- DrugIberdomide
Given orally (PO)
- DrugDexamethasone
Given PO
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
Location
- University of Calfornia, San FranciscoSan Francisco, California