Recruiting
Phase 3

Elranatamab & Daratumumab

Sponsor:

Pfizer

Code:

NCT05020236

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elranatamab

Daratumumab

Pomalidomide

Dexamethasone

Study Details

Brief summary:

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.

Conditions

Multiple Myeloma

Study ID

NCT05020236

Start date

Oct 4, 2021

Status verified date

Aug, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Feb 26, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
  • Measurable disease based on IMWG criteria as defined by at least 1 of the following:

  • Serum M-protein ≥0.5 g/dL.
  • Urinary M-protein excretion ≥200 mg/24 hours.
  • Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • Prior anti-multiple myeloma therapy including treatment with lenalidomide.
  • ECOG performance status ≤2.
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
  • Not pregnant and willing to use contraception.

Exclusion Criteria:

  • Smoldering multiple myeloma.
  • Plasma cell leukemia.
  • Amyloidosis.
  • POEMS Syndrome.
  • Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
  • Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
  • Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • Previous treatment with a BCMA-directed therapy.
  • Live attenuated vaccine within 4 weeks of the first dose of study intervention.
  • Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.

Study Design

Enrollment

893 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Elranatamab

subcutaneous

Daratumumab

Daratumumab / hyaluronidase, subcutaneous

Pomalidomide

oral

Dexamethasone

oral

Primary outcome measure

  • Part 1 Safety Lead-In: Incidence of dose limiting toxicities [ Time Frame: First 42 days after first elranatamab dose ]
  • Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria [ Time Frame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months ]
  • Part 3: Frequency of treatment-emergent adverse events [ Time Frame: First 84 days after first elranatamab dose ]

Central Contacts and Locations

Central contacts

Locations

Sylvester Comprehensive Cancer Center - Aventura

Recruiting

Aventura, Florida, United States, 33180

Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

Recruiting

Coral Gables, Florida, United States, 33146

Sylvester Comprehensive Cancer Center - Coral Springs

Recruiting

Coral Springs, Florida, United States, 33065

University of Miami Hospital and Clinics - Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Sylvester Comprehensive Cancer Center - Hollywood

Recruiting

Hollywood, Florida, United States, 33021

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

University of Miami Hospital and Clinics

Recruiting

Miami, Florida, United States, 33136

Sylvester Comprehensive Cancer Center - Kendall

Recruiting

Miami, Florida, United States, 33176

Sylvester Comprehensive Cancer Center - Plantation

Recruiting

Plantation, Florida, United States, 33324

MSK Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

MSK Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

MSK Bergen

Recruiting

Montvale, New Jersey, United States, 07645

MSK Commack

Recruiting

Commack, New York, United States, 11725

MSK Westchester

Recruiting

Harrison, New York, United States, 10604

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

Recruiting

New York, New York, United States, 10021

Memorial Sloan Kettering Cancer Center - Main Campus

Recruiting

New York, New York, United States, 10065

MSK Nassau

Recruiting

Uniondale, New York, United States, 11553

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

QEII Health Sciences Centre - Victoria General Site

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Saskatoon Cancer Center

Recruiting

Saskatoon, Saskatchewan, Canada, S7N4H4

More Information

Sponsor

Pfizer

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Elranatamab
  • PF-06863135
  • B-Cell Maturation Antigen
  • BCMA
  • Bispecific antibody
  • BCMA-CD3 bispecific antibody
  • Daratumumab
  • Pomalidomide
  • Multiple myeloma
  • Relapsed multiple myeloma
  • Refractory multiple myeloma
  • MagnetisMM-5

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-24.