Study on New Medication Combination for Treating Relapsed Multiple Myeloma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT07463807

Provider View

This clinical trial is testing a new combination of medications, teclistamab and pomalidomide, against the usual treatment for patients with multiple myeloma that has returned after initial improvement. The study aims to see if the new combination is safe and more effective in reducing cancer cells compared to the standard treatment.

Patient Parameters

Program Overview

This study is comparing a new treatment combination of teclistamab and pomalidomide with the usual treatment of carfilzomib, pomalidomide, and dexamethasone for patients whose multiple myeloma has come back after treatment. Teclistamab is a special type of antibody that targets cancer cells, while pomalidomide helps the immune system fight cancer. The study will evaluate if this new combination can safely and effectively lower cancer cell levels more than the standard treatment.

Description

The study is divided into two phases. In Phase Ib, researchers will determine the safest dose of pomalidomide to use with teclistamab and assess any side effects in patients with multiple myeloma that has returned after one or two treatments. In Phase II, the study will compare the effectiveness of the new combination (teclistamab and pomalidomide) against the standard treatment (carfilzomib, pomalidomide, and dexamethasone) in achieving a complete response with no detectable cancer cells after nine treatment cycles.

Participants will be randomly assigned to receive either the new combination or the standard treatment. The new combination involves receiving teclistamab through an injection under the skin and pomalidomide as a daily pill. The standard treatment includes carfilzomib given through an IV, pomalidomide as a daily pill, and dexamethasone either as a pill or IV. Treatment cycles repeat every 28 days for up to two years unless the disease progresses or side effects become unacceptable.

Throughout the study, participants will undergo various tests, including blood and urine samples, imaging scans, and bone marrow biopsies, to monitor their response to treatment. After completing the study treatment, participants will have follow-up visits every few months for up to 10 years to track their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have a specific genetic marker identified for Phase II.
  • Must have multiple myeloma with certain diagnostic criteria, including bone marrow involvement and symptoms like anemia, high calcium levels, bone disease, or kidney issues.
  • Must have experienced a relapse after one line of lenalidomide therapy.
  • Must have received no more than two lines of therapy.
  • Must not be receiving other investigational treatments.
  • Must have received lenalidomide and a CD38 antibody.
  • Must have measurable disease based on specific lab tests.
  • Must not be resistant to carfilzomib or pomalidomide.
  • Must not have received prior BCMA therapy.
  • Must not be pregnant and must agree to use effective contraception.
  • Must agree not to breastfeed during and after treatment.
  • Must agree not to donate eggs, sperm, or blood during and after treatment.
  • Must not have severe peripheral neuropathy or uncontrolled heart conditions.
  • Must not have allergies to study medications.
  • Must be able to understand and sign informed consent.
  • Must meet specific blood and organ function criteria.
  • HIV-positive patients must have an undetectable viral load.
  • Hepatitis B and C patients must have controlled or cured infections.
  • Patients with past CNS involvement must have no current CNS issues.
  • Patients with other cancers must not have conditions that interfere with the study.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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