Study Comparing Talquetamab with Daratumumab and Pomalidomide for Treating Multiple Myeloma That Returns or Resists Treatment

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05455320

Provider View

This clinical trial is testing different combinations of medications, including Talquetamab, Daratumumab, Pomalidomide, and Dexamethasone, to see which is most effective for patients with multiple myeloma that has come back or is not responding to treatment.

Patient Parameters

Program Overview

The study aims to find out if combining Talquetamab with other drugs like Daratumumab and Pomalidomide can better treat multiple myeloma that has returned or is resistant to treatment. The trial will compare these combinations to see which works best in controlling the disease.

Description

This study is exploring whether using different combinations of the drugs Talquetamab, Daratumumab, Pomalidomide, and Dexamethasone can improve treatment outcomes for patients with multiple myeloma that has returned or is resistant to previous treatments. The study is divided into three phases: screening, treatment, and follow-up. During the treatment phase, patients will receive the study drugs until their disease progresses, they experience intolerable side effects, they choose to stop, or the study ends. The follow-up phase will continue until the patient withdraws, is lost to follow-up, or the study concludes. Researchers will assess the effectiveness and safety of the treatments, as well as how the body processes the drugs and any immune responses. The study is expected to last up to 6 years and 6 months.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of multiple myeloma with measurable disease.
  • The disease must have returned after treatment or not responded to previous treatments.
  • Have received at least one prior treatment for multiple myeloma, including a proteasome inhibitor and lenalidomide.
  • Show evidence of disease progression after the last treatment.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.

Exclusion Criteria

  • Have severe allergies or intolerances to the study drugs.
  • The disease is resistant to anti-CD38 monoclonal antibodies.
  • Have previously received pomalidomide therapy.
  • Have taken high doses of corticosteroids recently.
  • Have active central nervous system involvement or signs of meningeal involvement.
  • Have plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloidosis.

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