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Evaluating new treatment combinations for newly diagnosed multiple myeloma patients not eligible for transplant

AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA

Phase 3 Interventional Pfizer · NCT05623020

This study is testing different combinations of medications for people with newly diagnosed multiple myeloma who can't have a transplant to see which one works best and is safest.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1116 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionschemotherapy, Elranatamab, Daratumumab
Locations39 sites (Fitzroy, Victoria and 38 other locations)
Trial IDNCT05623020 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of combining Elranatamab with Daratumumab and Lenalidomide, or Elranatamab with Lenalidomide, in comparison to the combination of Daratumumab, Lenalidomide, and Dexamethasone in patients with newly diagnosed multiple myeloma who are not candidates for transplant. The study is divided into two parts: the first part focuses on assessing the safety and tolerability of these combinations and determining the optimal dosing, while the second part evaluates the effectiveness in achieving minimal residual disease negativity and progression-free survival. The goal is to identify a more effective treatment regimen for this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with newly diagnosed multiple myeloma who are not eligible for transplant due to age or comorbidities.

Not a fit: Patients with multiple myeloma who are eligible for transplant or those with relapsed/refractory disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with newly diagnosed multiple myeloma who cannot undergo transplant.

How similar studies have performed: Other studies have shown promising results with similar treatment combinations in multiple myeloma, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Fitzroy, Victoria and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaElranatamabPF-06863135B-Cell Maturation AntigenDaratumumabLenalidomideMultiple myelomaMagnetisMM-6
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.