Study on Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone for Treating Relapsed or Resistant Multiple Myeloma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03763162

Provider View

This clinical trial is testing a combination of medications to see if they can better control multiple myeloma that has returned or is not responding to treatment. The study involves two phases of treatment with different drug combinations to evaluate their effectiveness and safety.

Patient Parameters

Program Overview

This study is exploring how well a combination of drugs—daratumumab, bortezomib, and dexamethasone—followed by daratumumab, ixazomib, and dexamethasone works in treating multiple myeloma that has come back or is resistant to treatment. Daratumumab is an immunotherapy that helps the immune system attack cancer cells. Bortezomib and ixazomib are drugs that block enzymes needed for cancer cell growth. Dexamethasone is a chemotherapy drug that stops cancer cells from growing. The study aims to see if these combinations can better control the cancer.

Description

The main goal of this study is to see how long patients can live without their disease getting worse when treated with the drug combinations. Researchers will also look at how many patients respond to the treatment, how quickly they respond, and how long the response lasts. They will also evaluate the overall survival of patients, the safety of the treatment, and the quality of life of participants.

Participants will first receive daratumumab, bortezomib, and dexamethasone for three cycles, each lasting 28 days. If the disease does not progress and there are no severe side effects, they will then receive daratumumab, ixazomib, and dexamethasone in subsequent cycles. The study will also collect samples to understand how the treatment works and why some patients might not respond.

After completing the study treatment, patients will be monitored for up to 24 months to check their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of multiple myeloma.
  • Must have measurable disease, such as a certain level of specific proteins in the blood or urine.
  • The disease must have returned or not responded to the most recent treatment.
  • Must have had one to three previous treatments for multiple myeloma.
  • Must have responded to at least one previous treatment.
  • Must be in good overall health with a performance status of 0, 1, or 2.
  • Must have adequate blood cell counts and organ function.
  • Must be willing to provide written consent to participate.
  • Women must not be pregnant and must agree to use effective contraception during and after the study.
  • Men must agree to use effective contraception during and after the study.

Exclusion Criteria

  • Cannot have received ixazomib or daratumumab before, except in specific circumstances.
  • Cannot be resistant to bortezomib or carfilzomib.
  • Cannot have allergies to the study drugs.
  • Cannot plan to undergo stem cell transplant before disease progression.
  • Cannot be taking certain medications that affect drug metabolism.
  • Must have completed previous cancer treatments within specified timeframes before starting the study.
  • Cannot have certain lung diseases or severe side effects from previous treatments.
  • Cannot have had major surgery recently.
  • Cannot have cancer spread to the brain.
  • Cannot have uncontrolled illnesses or infections.
  • Cannot have recent heart problems.
  • Cannot have digestive issues that affect medication absorption.
  • Cannot have active hepatitis B or C, or HIV.
  • Cannot have had another cancer within the last two years, except for certain skin cancers.
  • Cannot be pregnant or breastfeeding.
  • Cannot have had recent radiation therapy or participated in other clinical trials recently.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

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