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Comparing Elranatamab and Lenalidomide for Newly Diagnosed Multiple Myeloma After Transplant

A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION

Phase 3 Interventional Pfizer · NCT05317416

This study is testing whether a new injection called elranatamab works better than the oral medication lenalidomide for people with newly diagnosed multiple myeloma who have had a stem cell transplant.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment760 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionselranatamab
Locations224 sites (Gilbert, Arizona and 223 other locations)
Trial IDNCT05317416 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of elranatamab, a bispecific antibody, compared to lenalidomide in patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplant. Participants will be randomly assigned to receive either elranatamab via injection or lenalidomide orally. The study aims to determine if elranatamab can provide better clinical outcomes than lenalidomide. The duration of participation in the study is approximately five years.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with multiple myeloma who have undergone autologous stem cell transplant and meet specific criteria regarding disease status and response to prior treatments.

Not a fit: Patients who are not newly diagnosed or those who have not undergone an autologous stem cell transplant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients with newly diagnosed multiple myeloma, potentially improving survival rates.

How similar studies have performed: Other studies have shown promising results with bispecific antibodies in treating multiple myeloma, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
* Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
* History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
* Partial Response or better according to IMWG criteria at the time of randomization
* Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
* ECOG performance status ≤1
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
* Not pregnant and willing to use contraception

Exclusion Criteria:

* Plasma cell leukemia
* Amyloidosis, Waldenström's macroglobulinemia
* POEMS syndrome
* Known active CNS involvement or clinical signs of myelomatous meningeal involvement
* Previous MM maintenance treatment
* Prior treatment with BCMA targeted therapy
* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
* Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Where this trial is running

Gilbert, Arizona and 223 other locations

+174 more sites — see ClinicalTrials.gov for the full list.

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 MyelomaBCMANewly diagnosedElranatamabTargeted T-cellMagnetisMMMM7Phase 3
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.