A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Elranatamab — DRUG
  subcutaneous
• Daratumumab — DRUG
  Daratumumab / hyaluronidase, subcutaneous
• Pomalidomide — DRUG
  oral
• Dexamethasone — DRUG
  oral

Study Details

The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab. Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab. All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

Key Dates

Start date

Oct 4, 2021

Status verified

May 2026

Primary completion

Apr 27, 2026

Completion

May 31, 2027

Study Design

Enrollment

944 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab
• Experimental: Part 2 Randomized Arm A: Elranatamab
• Experimental: Part 2 Randomized Arm B: Elranatamab + Daratumumab
• Active Comparator: Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
• Experimental: Part 3 Arm D: Elranatamab
• Experimental: Part 3 Arm E: Elranatamab + Daratumumab

Primary Outcome Measure

Part 1 Safety Lead-In: Incidence of dose limiting toxicities [ Time Frame: First 42 days after first elranatamab dose ]

Central Contacts

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

Locations (11)

Related coverage on Hipa.ai

• Elranatamab Phase 3 Trial for Multiple Myeloma Reaches Primary Completion
  Elranatamab · Apr 27, 2026 · ClinicalTrials.gov

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