Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in San Francisco, California.

Sponsor
Alfred Chung, MD
Study ID
NCT06348108
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Talquetamab — BIOLOGICAL
    Given subcutaneously (SQ)
  • Iberdomide — DRUG
    Given orally (PO)
  • Dexamethasone — DRUG
    Given PO
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy

Study Details

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.

Key Dates

Start date
Jul 28, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohort: Dose Level (DL) 1 (Talquetamab, Iberdomide, Dexamethasone) - Starting Dose
    Participants receive 0.8 mg/kg Talquetamab (Tal) subcutaneously (SQ) over 1-3 minutes every 2 weeks (days 1 and 15 of each cycle), 0.75 mg Iberdomide orally (PO) once a day (QD) on days 1-21 of each 28-day cycle, and 20-40mg of Dexamethasone PO weekly, but may be continued at the discretion of the investigator. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Participants also undergo bone marrow biopsy, skeletal x-ray, CT, Positron Emission Tomography (PET)/CT, or MRI, tissue and blood sample collection throughout the study.
  • Experimental: Dose Escalation Cohort: DL 2 (Talquetamab, Iberdomide, Dexamethasone)
    Participants receive 0.8 mg/kg Talquetamab (Tal) subcutaneously (SQ) over 1-3 minutes every 2 weeks (days 1 and 15 of each cycle), 1.0 mg Iberdomide orally (PO) once a day (QD) on days 1-21 of each 28-day cycle, and 20-40mg of Dexamethasone PO weekly, but may be continued at the discretion of the investigator. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Participants also undergo bone marrow biopsy, skeletal x-ray, CT, Positron Emission Tomography (PET)/CT, or MRI, tissue and blood sample collection throughout the study.
  • Experimental: Dose Expansion Cohort (Talquetamab, Iberdomide, Dexamethasone)
    Participants receive the recommended phase 2 dose of Iberdomide in combination with Talquetamab and 20-40mg of Dexamethasone which may be continued at the discretion of the investigator. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Participants also undergo bone marrow biopsy, imaging scans, tissue and blood sample collection throughout the study.

Primary Outcome Measure

Proportion of participants reporting treatment-emergent adverse events (AEs) (Dose Escalation Cohorts) [ Time Frame: Up to 1 cycle (Cycles are 28 days in length) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Calfornia, San FranciscoSan FranciscoCalifornia94143
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
[email protected]
[email protected]
877-827-3222
Alfred Chung, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Calfornia, San Francisco· San Francisco, CA

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