Testing Combination Therapy in Adults with Newly Diagnosed Multiple Myeloma: The EQUATE Trial
Sponsor: ECOG-ACRIN Cancer Research Group
ClinicalTrials ID:NCT04566328
This study is comparing two treatment combinations for adults with newly diagnosed multiple myeloma to see which is more effective. One group will receive four drugs, while the other will receive three. The goal is to find out if adding the drug bortezomib improves treatment outcomes.
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Program Overview
This phase III trial is testing whether adding the drug bortezomib to a combination of three other drugs (daratumumab, lenalidomide, and dexamethasone) is more effective in treating newly diagnosed multiple myeloma than using the three drugs alone. Bortezomib may help stop cancer cells from growing by blocking certain enzymes. The other drugs work in different ways to kill cancer cells or stop them from spreading. The study aims to see if the four-drug combination can better shrink the cancer or prevent it from coming back compared to the three-drug combination.
Description
The main goal of this study is to see if adding bortezomib to the treatment of daratumumab, lenalidomide, and dexamethasone (Btz-DRd) after initial therapy improves overall survival in patients with minimal residual disease (MRD) positive multiple myeloma. Secondary goals include evaluating the treatment's effectiveness in MRD negative patients, comparing side effects, and assessing improvements in MRD status. The study also looks at patient-reported outcomes, such as neuropathy and quality of life, and uses imaging to predict treatment success.
Participants will first receive standard induction therapy with daratumumab, lenalidomide, and dexamethasone. After this, they will be randomly assigned to one of two groups:
- Group A (Btz-DRd): Patients will receive bortezomib, daratumumab, lenalidomide, and dexamethasone for consolidation, followed by maintenance therapy with daratumumab and lenalidomide.
- Group B (DRd): Patients will receive daratumumab, lenalidomide, and dexamethasone for consolidation, followed by the same maintenance therapy as Group A.
The study will follow patients for up to 15 years to monitor their health and treatment outcomes.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older with newly diagnosed multiple myeloma.
- Must have a performance status score of 0-2 (or 3 if due to pain).
- Must agree to participate in the REVLIMID Risk Evaluation and Mitigation Strategy (RevREMS) program.
- Must be able to provide a bone marrow sample for testing.
- Must have standard risk multiple myeloma based on specific medical criteria.
- Must have measurable disease based on certain lab tests.
- Must have adequate kidney, liver, and blood cell function.
- Must not have received more than one cycle of prior chemotherapy or certain doses of dexamethasone.
- Must not have been treated with daratumumab before.
- Must not have any serious medical conditions that could interfere with the study.
- Must not have uncontrolled asthma or other serious lung conditions.
- Must not have received any other cancer treatments outside of the study protocol.
- Must not be pregnant or breastfeeding and must agree to use effective contraception.
Exclusion Criteria
- Must not have allergies or sensitivities to the study drugs or their components.
- Must not have peripheral neuropathy of grade 2 or higher.
- Must not have any serious medical or psychiatric conditions that could interfere with the study.
- Must not have moderate or severe persistent asthma or uncontrolled asthma.
- Must not be receiving any other investigational treatments or therapies outside of the study protocol.
- Must not have received any non-study treatments after the initial induction phase.
- Must not be pregnant or breastfeeding and must agree to use effective contraception.
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