A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Elranatamab — DRUG
  Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
• Daratumumab — DRUG
  Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
• Lenalidomide — DRUG
  Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
• Dexamethasone — DRUG
  Randomized
• Bortezomib — DRUG
  Randomized

Study Details

Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.

Key Dates

Start date

Nov 10, 2022

Status verified

Jun 2026

Primary completion

Oct 18, 2030

Completion

Oct 3, 2033

Study Design

Enrollment

1,116 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide
• Experimental: Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide
• Experimental: Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide
• Active Comparator: Part 2 Randomized Arm B: Daratumumab + Bortezomib + Lenalidomide + Dexamethasone
• Experimental: Part 1: Elranatamab + Lenalidomide

Primary Outcome Measure

Part 1 Dose Limiting Toxicity [ Time Frame: From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (10)

Find similar trials in Basking Ridge, NJ

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