Study on Post-Transplant Maintenance Therapy with Isatuximab and Lenalidomide for High-Risk Multiple Myeloma Patients

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05776979

Provider View

This clinical trial is exploring whether the combination of isatuximab and lenalidomide can help control high-risk multiple myeloma in patients who have undergone an autologous stem cell transplant.

Patient Parameters

Program Overview

The aim of this study is to determine if using isatuximab together with lenalidomide after a stem cell transplant can effectively manage high-risk multiple myeloma. Researchers are particularly interested in seeing if this combination can help patients live longer without the disease getting worse, compared to past treatments.

Description

The study has several goals:

  • Primary Goal: To see if patients can live longer without their multiple myeloma getting worse over three years compared to historical data.

  • Secondary Goals: To evaluate how well the treatment works by looking at various factors such as the presence of minimal residual disease (MRD) after 12 months, the best response rate before the fourth cycle of isatuximab and at different intervals, the duration of response, overall survival, and the safety of the treatment.

Participants will be monitored for these outcomes to assess the effectiveness and safety of the treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 70 with newly diagnosed symptomatic multiple myeloma.
  • Must have measurable disease at diagnosis, such as specific levels of M-protein or lesions visible on imaging.
  • Must have high-risk myeloma, defined by certain genetic markers or stages.
  • Must have undergone a stem cell transplant and recovered adequately.
  • Must have achieved at least a partial response to initial treatment.
  • Must have good organ function and meet specific blood test criteria.
  • Must not be pregnant or breastfeeding, and must agree to use effective birth control.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Progression of myeloma before starting maintenance therapy.
  • Recent use of other investigational drugs.
  • Allergic reactions to study drugs or their components.
  • Active infections or uncontrolled health conditions.
  • Recent major surgery.
  • HIV-positive or active hepatitis infections.

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