Elranatamab for High-Risk Multiple Myeloma Before and After Transplant

This study is looking at whether a drug called elranatamab, given before and after an autologous stem cell transplant (ASTC), can help control newly diagnosed, high-risk multiple myeloma (a type of blood cancer). An ASTC is a procedure where your own healthy stem cells are collected and then returned to you after high-dose treatment. You might also receive other medications like lenalidomide, plerixafor, melphalan, and busulfan. The study aims to see how many participants achieve a sustained "MRD-negative CR status," meaning no signs of cancer cells are detected over time. To join, you must be 18 to 75 years old, have newly diagnosed high-risk multiple myeloma, and have responded well to initial treatment. The study plans to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 40 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured through study completion, which is an average of one year.

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NCT06207799

Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma

Recruiting
PHASE2Ages 18–75InterventionalTreatment
M.D. Anderson Cancer Center
~40 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:ElranatamabLenalidomidePlerixaforMelphalanBusulfanG-CSF

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year
Multiple Myeloma
Post-transplant MRD-guided Maintenance Therapy
Pre-transplant Purging
1 sites across 1 states
Texas1
  • Qaiser Bashir, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Eligibility criteria

Inclusion

≥ 45 years of age and has not had menses for \>1 year.
Participants who have been amenorrhoeic for \<2 years without a history of a hysterectomy and oophorectomy must have a follicle-stimulating hormone value in the postmenopausal range upon screening evaluation.
Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. 11. Male participant agrees to contraceptive use that should be consistent with institutional guidelines regarding the methods of contraception for those participating in clinical studies.
Male participants are eligible to participate if they agree to the following during the intervention period and for 1 (for lenalidomide) to 4 (for elranatamab) months after the last dose of study treatment to allow for clearance of any altered sperm: - Refrain from donating sperm during treatment (including dose interruptions) and for 4 weeks after their last dose of lenalidomide and 4 months after the last dose of elranatamab.
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
Must agree to use contraception/barrier as detailed in Appendix B. \*Definition of high-risk and ultra-high-risk MM15:
High-risk MM:
Ultra-high-risk MM
Presence of ≥2 HRCA.
Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.
History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.
Class III or IV heart failure as defined by the New York Heart Association functional classification system.16
Uncontrolled hypertension (blood pressure that remains above goal despite the concurrent use of three antihypertensive drug classes). • Participant must not have known HIV infection. • Participant must not have active Hepatitis B and/or C infection. • Participant must not have invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction. • Participants must not be pregnant or lactating. • Patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.
  • Safety and adverse events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0