Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06207799

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

Led by M.D. Anderson Cancer Center · Updated on 2026-02-19

40

Participants Needed

1

Research Sites

389 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

P

Pfizer

Collaborating Sponsor

AI-Summary

What this Trial Is About

To learn if giving elranatamab before and after an autologous stem cell transplant (ASTC) can help to control newly diagnosed, high-risk MM. An ASTC is a type of transplant in which a person's own stem cells are collected, preserved, and returned to them.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Transplant eligible patients with newly diagnosed multiple myeloma (NDMM)
  • High-risk multiple myeloma
  • Participants with disease response \u2265 partial response to induction therapy
  • Age \u2265 18 and \u2264 75 years
  • Karnofsky performance status \u2265 70
  • Adequate liver function (total bilirubin \u2264 1.5 times upper limit normal; ALT \u2264 2.5 times upper limit normal)
  • Estimated creatinine clearance \u2265 40 mL/min
  • Agreement not to donate blood while taking lenalidomide and for 28 days after stopping
  • Enrollment in the lenalidomide REMS program
  • Women of child-bearing potential must use highly effective contraception and have negative pregnancy tests
  • Male participants must agree to contraceptive use and to refrain from sperm donation during and after treatment
Not Eligible

You will not qualify if you...

  • History of allergic reactions to elranatamab or similar agents
  • Use of drugs that significantly interact with elranatamab unless medically necessary
  • History of progressive disease before maintenance therapy
  • Non-secretory multiple myeloma without measurable disease, unless measurable by PET scan or bone marrow
  • Waldenstr�f6ms macroglobulinemia
  • POEMS syndrome
  • Smoldering multiple myeloma
  • Plasma cell leukemia
  • Standard-risk multiple myeloma
  • Relapsed or refractory multiple myeloma
  • Active renal conditions affecting safety
  • Unstable liver or biliary disease
  • Uncontrolled and active pulmonary disease
  • Recent use of investigational or systemic anti-myeloma therapy within 14 days
  • Active mucosal or internal bleeding
  • Uncontrolled infection
  • Cardiovascular risks including significant arrhythmias, recent myocardial infarction, severe heart failure, or uncontrolled hypertension
  • Known HIV infection
  • Active Hepatitis B or C infection
  • Other invasive malignancies unless stable for 2 years
  • Pregnant or lactating
  • Cognitive impairments or serious unstable medical or psychiatric conditions interfering with safety or consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

Q

Qaiser Bashir, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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