Study on the Safety and Effectiveness of Forimtamig-Based Treatments for Relapsed or Refractory Multiple Myeloma

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06055075

This clinical trial is testing the safety and effectiveness of a new treatment called forimtamig, used alone or with other drugs, for patients with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The aim of this study is to see if a new treatment, forimtamig, is safe and can help reduce tumors in patients with multiple myeloma that has come back or not responded to other treatments. The study will test forimtamig by itself and in combination with other drugs like carfilzomib or daratumumab. It will be conducted in two parts: first, to find the best dose, and second, to see how well it works at that dose.

Eligibility Criteria

Inclusion Criteria

  • Must be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Expected to live at least 12 more weeks.
  • Have a confirmed diagnosis of multiple myeloma based on specific medical criteria.
  • Show signs of disease progression after the last treatment, as determined by a doctor.
  • Have measurable disease that can be tracked.
  • Any side effects from previous cancer treatments must be mild or resolved.
  • Must have adequate organ function as determined by medical tests.

Exclusion Criteria

  • Cannot be pregnant, breastfeeding, or planning to become pregnant during the study or within 3 months after the last dose.
  • Cannot have plasma cell leukemia with a high number of circulating plasma cells.
  • Cannot have known amyloidosis or myelodysplastic syndrome.
  • Cannot have had certain antibody treatments within 4 weeks or 5 half-lives of the drug, whichever is shorter.
  • Cannot have had other cancer treatments within 14 days before starting forimtamig.
  • Cannot have had a solid organ transplant.
  • Cannot have an active autoimmune disease or recent flare-up.
  • Cannot have a known or suspected chronic Epstein-Barr virus infection.
  • Cannot have hepatitis B or C infections.
  • Cannot have a known history of HIV.
  • Cannot have received live vaccines within one month before starting treatment.
  • Must be fully vaccinated for COVID-19 as per local guidelines.
  • Cannot have been previously unresponsive to carfilzomib.
  • Cannot have stopped carfilzomib due to side effects.
  • Cannot have known liver cirrhosis.
  • Cannot be eligible for stem cell transplantation at the time of enrollment.

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