Study on Pre-transplant and Post-transplant Therapy with Elranatamab for High-risk Multiple Myeloma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06207799

Provider View

This clinical trial is exploring whether using the drug elranatamab before and after a stem cell transplant can help control high-risk multiple myeloma, a type of blood cancer. The study focuses on patients who are newly diagnosed and eligible for a transplant.

Patient Parameters

Program Overview

The aim of this study is to find out if giving the drug elranatamab before and after an autologous stem cell transplant (where a patient's own stem cells are used) can help manage high-risk multiple myeloma. This approach is being tested to see if it can help patients achieve a state where no minimal residual disease (MRD) is detected, meaning no cancer cells are found in the body after treatment.

Description

The main goals of this study are to see how many patients with high-risk multiple myeloma can achieve a long-lasting state where no cancer cells are detected after treatment with elranatamab, a stem cell transplant, and maintenance therapy. Researchers will also look at how well elranatamab helps in collecting healthy stem cells before the transplant and how safe and tolerable the combination of elranatamab and lenalidomide is after the transplant.

Secondary goals include measuring the response rates to the treatment, the time patients remain free from disease progression, and overall survival rates. The study will also assess the impact of stopping maintenance therapy after achieving a complete response and sustained MRD-negative status.

Eligibility Criteria

Inclusion Criteria

  • Patients eligible for a stem cell transplant with newly diagnosed multiple myeloma.
  • Classified as having high-risk multiple myeloma.
  • Must have shown at least a partial response to initial treatment.
  • Aged between 18 and 75 years old.
  • Must have a performance status score of 70 or higher, indicating they are able to care for themselves.
  • Must have adequate liver function and kidney function.
  • Must agree not to donate blood while taking lenalidomide and for 28 days after stopping it.
  • Must enroll in the lenalidomide REMS program.
  • Women of childbearing potential must use effective birth control and agree not to donate eggs during the study and for a specified period after.
  • Men must agree to use contraception and not donate sperm during the study and for a specified period after.

Exclusion Criteria

  • History of allergic reactions to similar drugs as elranatamab.
  • Use of certain medications that may interact with elranatamab unless necessary.
  • History of progressive disease before starting maintenance therapy.
  • Non-secretory multiple myeloma or other specific types of blood disorders.
  • Active kidney, liver, or lung disease that is not stable.
  • Use of investigational drugs or other anti-myeloma treatments shortly before the study.
  • Active infections or bleeding disorders.
  • Significant heart problems or uncontrolled high blood pressure.
  • Known HIV or active Hepatitis B or C infections.
  • Other invasive cancers unless stable for at least 2 years.
  • Pregnant or breastfeeding women.
  • Cognitive impairments or serious medical or psychiatric conditions that could interfere with the study.

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