Study on Isa-Pom-Dex for Elderly or Frail Patients with Relapsed or Refractory Multiple Myeloma

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05911321

Provider View

This clinical trial is testing a combination of three drugs—isatuximab, pomalidomide, and dexamethasone (Isa-Pd)—to see if they are safe and effective for treating multiple myeloma that has returned or not responded to previous treatments, especially in older or frail patients.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of three drugs—isatuximab, pomalidomide, and dexamethasone (Isa-Pd)—can safely and effectively treat multiple myeloma that has come back or not responded to earlier treatments. The study focuses on using lower doses of pomalidomide and dexamethasone, which are not yet approved by the FDA for this use. This research is particularly aimed at older or frail patients who may not tolerate standard chemotherapy doses well.

Description

This study is designed to help older or frail patients with relapsed or refractory multiple myeloma (RRMM) who may not be able to handle the usual full doses of chemotherapy. Often, these patients are not included in traditional clinical trials, so this study aims to fill that gap. It will involve 49 patients and will test the safety and effectiveness of a drug combination called Isa-Pd, which includes isatuximab, pomalidomide, and dexamethasone at lower doses than usual. The main goal is to see how well the treatment works, while also looking at side effects and how well patients tolerate it. Participants will also be assessed on their quality of life and other health factors related to aging and frailty.

The length of time patients will be in the study depends on how they respond to the treatment. If there are no delays due to side effects, treatment will continue until the disease progresses, side effects become unacceptable, another illness occurs, or the patient decides to stop. On average, treatment is expected to last about 10 months.

After treatment ends, all participants will be monitored until they either pass away or choose to leave the study for other reasons. Those who stop treatment due to side effects will be followed until those side effects improve or stabilize.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate and allow access to personal health information.
  • Must be 18 years or older.
  • Have multiple myeloma that has returned or not responded to previous treatments.
  • Must have tried at least one previous treatment that included specific types of drugs and shown resistance to it.
  • Must be able to attend study visits and follow the study requirements.
  • Must be considered at high risk for severe side effects from standard treatments due to age, frailty, or past treatment experiences.

Exclusion Criteria

  • Have received any anti-myeloma treatment within two weeks before starting the study.
  • Have been treated with pomalidomide before.
  • Have received any monoclonal antibody therapy in the last 30 days.
  • Have received anti-CD38 monoclonal antibody therapy in the last 6 months.
  • Have had a stem cell transplant within 12 weeks before starting the study.
  • Are not considered suitable for any systemic therapy due to severe health issues or frailty.

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