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Tailored drug strategy aims to keep myeloma in check after transplant

NCT ID NCT06483100

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests a personalized approach for people with newly diagnosed multiple myeloma who have had a stem cell transplant. After transplant, participants receive the drug elranatamab as maintenance therapy, with the dose and duration guided by a sensitive blood test (MRD testing) that detects very low levels of remaining cancer cells. The goal is to see if this tailored strategy can delay cancer progression and improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Criteria for Pre-Screening Blood Draw * Newly diagnosed multiple myeloma (either untreated or receiving first line therapy). * Potentially eligible for autologous hematopoietic cell transplant (with or without tandem transplant) for frontline therapy. Inclusion Criteria: * 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 Criteria: * Inability to identify a trackable clonoSEQ ID. * A history of other malignancy with the exception of non-melanoma skin cancers, low or very low risk prostate cancer by NCCN criteria status post definitive therapy or currently on active surveillance, and malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease. Adjuvant endocrine therapy for hormone receptor-positive breast cancer is not exclusionary. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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