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Elranatamab Maintenance for Newly Diagnosed Multiple Myeloma

This study is for people with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant (a procedure where your own stem cells are used after high-dose chemotherapy). It's testing a personalized approach using a drug called elranatamab. After your transplant, you would receive elranatamab, and doctors would use a special test called clonoSEQ to check for measurable residual disease (MRD), which means a very small number of myeloma cells that might still be in your body. The goal is to see if guiding treatment with this MRD test can improve how long people live without their cancer getting worse and how many people achieve MRD negativity. The study plans to enroll 65 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 65 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure progression-free survival and up to 36 months to measure MRD negativity.

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NCT06483100

Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance

Recruiting
PHASE2Ages 18+InterventionalTreatment
Washington University School of Medicine
~65 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:ElrantamabclonoSEQ

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over Through completion of follow-up (up to 5 years)
+1 more outcome measured

Conditions

Multiple Myeloma

Explore related trials

Multiple MyelomaMBD5 wt Allele

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Michael Slade, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Michael Slade, M.D.
[email protected]
314-454-8304
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Eligibility criteria

Inclusion

At least 18 years of age
Ability to understand and willingness to sign an IRB approved written informed consent document. (Legally authorized representatives may sign and give informed consent on behalf of study participants.)
Received autologous hematopoietic cell transplantation (with or without tandem transplant) as part of frontline therapy for newly diagnosed IgG or IgA multiple myeloma. Frontline therapy in this setting is defined as treatment received prior to first relapse and may include multiple lines of therapy per the Rajkumar et al definition if treatment changes were made for either toxicity or inadequate response to initial induction.
Received frontline treatment with at least a triplet regimen including a PI and an IMID (+/- an anti-CD38 antibody)
Disease response of ≥ partial response (PR) by IMWG criteria at time of study screening (post-transplant).
MRD-positive on Day 100 landmark assessment (80 to 160 days after AHCT), defined as \>1 x 10-5 myeloma cells/cell by clonoSEQ assay (Adaptive Biotechnologies, Seattle, WA) performed on bone marrow aspirate.
ECOG performance status ≤ 2
All toxicities from prior treatment should have resolved to Grade ≤ 1 prior to enrollment.
Adequate bone marrow and organ function within 28 days prior to start of treatment as defined below:
Platelets ≥ 75 k/cumm
Absolute neutrophil count ≥ 1.0 k/cumm
Hemoglobin ≥ 8 g/dL without the use of growth factors or transfusion for at least 2 weeks.
Total bilirubin ≤ 2 × upper limit of normal (ULN; ≤ 3 x ULN if documented Gilbert's syndrome)
Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN
Creatinine clearance ≥ 30 ml/min.
The effects of elranatamab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months after end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.

Exclusion

Inability to identify a trackable clonoSEQ ID.
Currently receiving any other investigational agents.
Prior BCMA-based treatment.
CNS involvement of disease.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to elranatamab or other agents used in the study.
Uncontrolled intercurrent illness including, but not limited to, plasma cell leukemia, POEMS syndrome, systemic amyloidosis, ongoing or active infection (bacterial, fungal, or viral).
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to first dose of elranatamab.
HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.

What this trial measures

  • Progression-free survival (PFS)Through completion of follow-up (up to 5 years)

    Progression-free survival (PFS) is defined as time to progression or death.

  • Proportion of patients achieving MRD negativity at the 10^-5 threshold per the clonoSEQ assayThrough completion of end of study visit (up to 36 months)