Recruiting
Phase 3

Elranatamab & Lenalidomide, Daratumumab, Dexamethasone

Sponsor:

Pfizer

Code:

NCT05623020

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elranatamab

Daratumumab

Lenalidomide

Dexamethasone

Bortezomib

Study Details

Brief summary:

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.

Conditions

Multiple Myeloma

Study ID

NCT05623020

Start date

Nov 10, 2022

Status verified date

Oct, 2026

Completion date

Oct 3, 2033

Anticipated

Primary completion date

Oct 18, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of multiple myeloma (MM) 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 (Part 1) and ≥1 g/dL (Part 2);
  • Urinary M-protein excretion ≥200 mg/24 hours;
  • Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant.
  • Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as:

  • Participants not considered candidates for high-dose chemotherapy and ASCT due to age or
  • Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT.
  • ECOG performance status ≤2.
  • Not pregnant and willing to use contraception
  • For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.

Exclusion Criteria:

  • Smoldering Multiple Myeloma.
  • Monoclonal gammopathy of undetermined significance.
  • Waldenströms Macroglobulinemia
  • Plasma cell leukemia.
  • Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
  • For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.
  • For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, total of 160 mg dexamethasone or equivalent before the first dose of study intervention). A cumulative dose of systemic corticosteroids equivalent to ≥20 mg of dexamethasone during screening.
  • Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.
  • Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.

Study Design

Enrollment

1060 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Elranatamab

Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

Daratumumab

Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

Lenalidomide

Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

Dexamethasone

Randomized

Bortezomib

Randomized

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 ]
  • Part 2: Progression free survival per IMWG [ Time Frame: From randomization up to 97 months. ]
  • Part 2: Minimal Residual Disease negative CR rate [ Time Frame: At 12 months after randomization ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Gulf Health Hospitals, Inc. d/b/a Infirmary Cancer Care - Malbis

Recruiting

Daphne, Alabama, United States, 36526

Gulf Health Hospitals, Inc. d/b/a Thomas Medical Center

Recruiting

Daphne, Alabama, United States, 36526

Gulf Health Hospitals, Inc. d/b/a Infirmary Cancer Care - Fairhope

Recruiting

Fairhope, Alabama, United States, 36532

Mobile Infirmary Association d/b/a Mobile Infirmary Medical Center

Recruiting

Mobile, Alabama, United States, 36606

Gulf Health Hospitals, Inc. d/b/a Infirmary Cancer Care - Mobile

Recruiting

Mobile, Alabama, United States, 36607

Mobile Infirmary Medical Center

Recruiting

Mobile, Alabama, United States, 36607

Mobile Infirmary Association d/b/a Mobile Infirmary Medical Center.

Recruiting

Mobile, Alabama, United States, 36695

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- Doral

Recruiting

Doral, Florida, United States, 33166

Sylvester Comprehensive Cancer Center - Hollywood

Recruiting

Hollywood, Florida, United States, 33021

Jupiter Medical Center/Anderson Family Cancer Institute

Recruiting

Jupiter, Florida, United States, 33458

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 - Sole Mia

Recruiting

North Miami, Florida, United States, 33181

Sylvester Comprehensive Cancer Center - Plantation

Recruiting

Plantation, Florida, United States, 33324

NHO Revive Research Institute, LLC

Recruiting

Lincoln, Nebraska, United States, 68506

Renown Health Medical Oncology

Recruiting

Reno, Nevada, United States, 89502

Renown Office of Clinical Research

Recruiting

Reno, Nevada, United States, 89502

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

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

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

LDS Hospital

Recruiting

Salt Lake City, Utah, United States, 84143

Intermountain Cancer Center St. George

Recruiting

St. George, Utah, United States, 84790

St. George Regional Hospital

Recruiting

St. George, Utah, United States, 84790

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Dr. Everett Chalmers Regional Hospital

Recruiting

Fredericton, New Brunswick, Canada, E3B 5N5

QEII Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3S 0H6

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Pfizer

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Keywords

  • Elranatamab
  • PF-06863135
  • B-Cell Maturation Antigen
  • Daratumumab
  • Lenalidomide
  • Multiple myeloma
  • MagnetisMM-6
  • Bortezomib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Pfizer on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.