Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

NCT04566328

Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial

Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-05

1450

Participants Needed

600

Research Sites

357 weeks

Total Duration

AI-Summary

What this Trial Is About

This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.

CONDITIONS

Official Title

Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient has an ECOG performance status of 0-2 (3 allowed if due to pain)
Newly diagnosed multiple myeloma by International Myeloma Working Group criteria
Registered and compliant with the REVLIMID Risk Evaluation and Mitigation Strategy (RevREMS) program
Able to undergo diagnostic bone marrow aspirate for clonoSEQ assay
Standard risk multiple myeloma defined as RISS stage I or II
Measurable or evaluable disease by specific protein and bone marrow criteria within 28 days prior to registration
Serum protein electrophoresis, urine protein electrophoresis, and serum free light chain tests performed within 28 days prior to registration
Creatinine clearance greater than 30 mL/min within 14 days prior to registration
Absolute neutrophil count of 1000/mm3 or higher within 14 days prior to registration
Platelet count of at least 75,000/mm3 within 14 days prior to registration
Hemoglobin level of 8.0 g/dL or higher within 14 days prior to registration
Total bilirubin less than or equal to 1.5 times the upper limit of normal within 14 days prior to registration
ALT and AST less than or equal to 3 times the upper limit of normal within 14 days prior to registration
No more than one cycle of prior chemotherapy and no prior daratumumab exposure
HIV-infected patients on effective therapy with undetectable viral load within 6 months are eligible
Controlled hepatitis B or cured hepatitis C infection as specified
Prior or concurrent malignancy allowed if not interfering with study treatment
Cardiac function classified as New York Heart Association Class 2B or better without uncontrolled conditions
History of deep vein thrombosis or pulmonary embolism allowed with willingness to use anticoagulation if needed
COPD patients must have FEV1 over 50% of predicted normal within 28 days prior to registration
Completed induction phase without progression and registered to Step 2 within 8 weeks
ECOG performance status 0-2 (3 allowed if due to pain) at Step 2
Adverse events from induction must be resolved to grade 2 or less
Hemoglobin 8 g/dL or higher, platelet count 50,000/mm3 or higher, ANC 1000/mm3 or higher, creatinine clearance 30 mL/min or higher, total bilirubin ≤1.5 x ULN, ALT and AST <3 x ULN within 14 days prior to Step 2 randomization

You will not qualify if you...

Known allergies or intolerance to corticosteroids, monoclonal antibodies, human proteins, or mammalian-derived products
Pregnant or breastfeeding women
Women of childbearing potential not using two effective contraception methods or true abstinence
Men not using latex condoms with female partners of childbearing potential or not agreeing to abstain from sperm donation as specified
Peripheral neuropathy grade 2 or higher, or grade 1 with pain at registration
Serious medical or psychiatric illness interfering with treatment
Moderate or severe persistent asthma within past 2 years or uncontrolled asthma
Receiving other concurrent chemotherapy or investigational therapy (bisphosphonates are allowed)
Receipt of non-protocol therapy outside assigned induction including stem cell transplant
Uncontrolled cardiovascular conditions including hypertension, arrhythmias, heart failure, unstable angina, or recent myocardial infarction
Women pregnant or breastfeeding at Step 2
Women and men not following contraception and abstinence requirements at Step 2

AI-Screening

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Trial Site Locations

Total: 600 locations

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Actively Recruiting

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States, 99504

Actively Recruiting

Alaska Breast Care and Surgery LLC