OncoMatch/Clinical Trials/NCT04566328
Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial
Is NCT04566328 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Daratumumab and Hyaluronidase-fihj and Bortezomib for plasma cell myeloma.
Treatment: Bortezomib · Daratumumab and Hyaluronidase-fihj · Dexamethasone · Lenalidomide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Disease stage
Required: Stage I, II
Excluded: Stage III
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: daratumumab (daratumumab)
Patient must not have been exposed to daratumumab for treatment of symptomatic myeloma
Cannot have received: stem cell transplant
Patient must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant
Lab requirements
Blood counts
ANC ≥ 1000/mm^3; untransfused platelet count ≥ 75,000/mm^3 (Step 1), ≥ 50,000/mm^3 (Step 2); hemoglobin ≥ 8.0 g/dL
Kidney function
Calculated creatinine clearance > 30 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3 x ULN
Cardiac function
NYHA class 2B or better; no evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within 6 months
Calculated creatinine clearance > 30 mL/min; ANC ≥ 1000/mm^3; untransfused platelet count ≥ 75,000/mm^3; hemoglobin ≥ 8.0 g/dL; Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3 x ULN; NYHA class 2B or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Virginia Cancer Institute · Richmond, Virginia
- Virginia Commonwealth University/Massey Cancer Center · Richmond, Virginia
- VCU Community Memorial Health Center · South Hill, Virginia
- Providence Regional Cancer System-Aberdeen · Aberdeen, Washington
- PeaceHealth Saint Joseph Medical Center · Bellingham, Washington
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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