Testing a New Treatment Approach for Plasma Cell Leukemia: The QUANTUM Trial

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT07605416

Provider View

This study is exploring whether a new combination of treatments can improve survival in patients with plasma cell leukemia. It compares two different follow-up treatments after initial therapy and stem cell transplant to see which is more effective.

Patient Parameters

Program Overview

This trial is testing two different follow-up treatments for patients with plasma cell leukemia after they have received initial therapy and a stem cell transplant. The study aims to find out if adding a new drug, teclistamab, can improve survival compared to the standard treatment. The standard treatment includes drugs like daratumumab, carfilzomib, lenalidomide, and dexamethasone, which work in different ways to help the immune system fight cancer and reduce inflammation. Teclistamab is a new type of drug that may help stop cancer cells from growing and spreading. The study will help determine which treatment is more effective in improving patient outcomes.

Description

The QUANTUM trial is designed to test if a new treatment approach can improve survival for patients with plasma cell leukemia. The study involves several stages of treatment:

  1. Induction Therapy (Cycles 1-4): Patients receive a combination of drugs including daratumumab, carfilzomib, lenalidomide, and dexamethasone to reduce cancer cells. This phase lasts for up to 4 cycles, each 28 days long.

  2. Stem Cell Transplant: After induction therapy, patients undergo a stem cell transplant to replace damaged cells with healthy ones.

  3. Consolidation Therapy (Cycles 5-12): Patients are randomly assigned to one of two groups:

    • Group 1: Continues with the standard treatment of daratumumab, carfilzomib, lenalidomide, and dexamethasone.
    • Group 2: Receives teclistamab, a new drug that may help stop cancer cells from growing.

  4. Maintenance Therapy (Cycles 13-36): Patients receive ongoing treatment with carfilzomib and lenalidomide to keep the cancer under control.

Throughout the study, patients will have regular check-ups, including heart tests, blood samples, and scans to monitor their health and the effectiveness of the treatment. After completing the study treatment, patients will be followed up every few months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with plasma cell leukemia with at least 5% circulating plasma cells.
  • Have measurable disease based on specific medical tests.
  • Aged between 18 and 80 years.
  • Have not received more than one cycle of prior treatment.
  • No severe allergic reactions to similar drugs.
  • In good general health with a performance status of 0 to 2.
  • Not pregnant or nursing, and willing to use effective birth control.
  • No significant heart problems or uncontrolled high blood pressure.
  • No severe nerve damage or allergies to study drugs.
  • Able to swallow pills and have no major surgery within the last 2 weeks.
  • Meet specific blood count and organ function criteria.
  • No active infections like HIV or hepatitis unless well-controlled.

Locations

FACILITYZIPCITYSTATE
Alliance for Clinical Trials in Oncology60606ChicagoIllinois

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