Study on Daratumumab, Ixazomib, and Dexamethasone or Daratumumab, Bortezomib, and Dexamethasone for Newly Diagnosed Multiple Myeloma

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03942224

Provider View

This clinical trial is exploring two different combinations of medications to treat patients who have been newly diagnosed with multiple myeloma, a type of blood cancer. The study aims to find out which combination works better in controlling the disease.

Patient Parameters

Program Overview

This study is testing two different treatment combinations for patients with newly diagnosed multiple myeloma. The first combination includes daratumumab, ixazomib, and dexamethasone, while the second includes daratumumab, bortezomib, and dexamethasone. These treatments aim to help the immune system attack cancer cells and stop them from growing and spreading. Researchers want to see which combination is more effective in treating multiple myeloma.

Description

The main goal of this study is to see how well the two different treatment combinations work in achieving a very good partial response or better after 8 cycles of treatment. The study will also look at how well patients can mobilize stem cells after 3 cycles of treatment, the safety of the treatments, and the overall response rates, including complete response and minimal residual disease negativity. Other objectives include measuring progression-free survival, overall survival, and the time to next therapy.

Participants will be randomly assigned to one of two groups:

Group 1:

  • Induction Phase: Patients receive dexamethasone, daratumumab, and ixazomib for 8 cycles, each lasting 28 days. If eligible, patients may undergo a stem cell transplant.
  • Maintenance Phase: Patients continue with dexamethasone, daratumumab, and ixazomib for up to 24 months.

Group 2:

  • Induction Phase (Cycles 1-3): Patients receive dexamethasone, daratumumab, and bortezomib for 3 cycles, each lasting 21 days.
  • Induction Phase (Cycles 4-8): Patients receive dexamethasone, daratumumab, and ixazomib for 5 cycles, each lasting 28 days. If eligible, patients may undergo a stem cell transplant.
  • Maintenance Phase: Patients continue with dexamethasone, daratumumab, and ixazomib for up to 24 months.

After completing the study treatment, patients will have follow-up visits every 3 months.

Eligibility Criteria

Inclusion Criteria

  • Must be willing and able to follow the study requirements.
  • Must provide written informed consent.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have a confirmed diagnosis of multiple myeloma with specific criteria, such as a certain percentage of plasma cells in the bone marrow or evidence of organ damage related to the disease.
  • Must have measurable disease based on specific protein levels in the blood or urine.
  • Prior treatment with certain steroids or bortezomib is allowed to stabilize the patient.
  • Must agree to avoid donating blood during and for 8 weeks after the study.
  • Female participants must meet specific criteria regarding pregnancy and contraception.
  • Male participants must agree to use effective contraception or practice abstinence during and after the study.

Exclusion Criteria

  • Diagnosed with other related conditions like smoldering multiple myeloma or amyloidosis.
  • Have severe nerve damage or pain.
  • Have severe kidney problems.
  • Have low blood cell counts that cannot be corrected before the study.
  • Have significant liver problems.
  • Have serious heart conditions or recent heart attacks.
  • Have severe lung diseases or uncontrolled asthma.
  • Have active infections like HIV or hepatitis.
  • Have other serious medical conditions that could interfere with the study.
  • Have had another cancer within the last 2 years, except for certain skin cancers.
  • Are pregnant or breastfeeding.
  • Have had major surgery recently or have not recovered from surgery.
  • Have a history of non-compliance with medical treatments.
  • Have had previous treatment with certain study drugs or participated in other clinical trials recently.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.