OncoMatch/Clinical Trials/NCT05561387
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
Is NCT05561387 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Bortezomib and Daratumumab and Hyaluronidase-fihj for plasma cell myeloma.
Treatment: Bortezomib · Daratumumab and Hyaluronidase-fihj · Dexamethasone · Lenalidomide — This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. 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. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG/ZUBROD 0–2
Prior therapy
Cannot have received: systemic therapy
Exception: emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration; up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen; localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol
Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following: An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol.
Lab requirements
Blood counts
For 'frail': Hemoglobin ≥ 7 g/dL, Platelets ≥ 50 x 10^9/L, ANC ≥ 0.75 x10^9/L; For 'intermediate fit': Hemoglobin 7-8 g/dL OR Platelets 50-75 x10^9/L OR ANC 0.75-1 x10^9/L (growth factor and transfusion utilization allowed if cytopenias are considered secondary to bone marrow involvement from MM)
Kidney function
Kidney dysfunction allowed for 'frail' status except dialysis excluded; for 'intermediate fit' status, CrCl < 30 ml/min (actual lab serum creatinine value with a minimum of 0.7 mg/dL)
Liver function
Total bilirubin ≤ 2 x institutional ULN unless history of Gilbert's disease (then ≤ 5 x ULN); AST/ALT ≤ 3 x institutional ULN
Cardiac function
Adequate cardiac function as assessed by treating physician; if cardiac disease history or symptoms or prior cardiotoxic agents, must not be NYHA class 3 or 4
Total bilirubin ≤ 2 x institutional ULN unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration); AST/ALT ≤ 3 × institutional ULN (within 28 days prior to registration); For 'frail': Hemoglobin ≥ 7 g/dL, Platelets ≥ 50 x 10^9/L, ANC ≥ 0.75 x10^9/L; For 'intermediate fit': Hemoglobin 7-8 g/dL OR Platelets 50-75 x10^9/L OR ANC 0.75-1 x10^9/L; Adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
- Alaska Oncology and Hematology LLC · Anchorage, Alaska
- Alaska Women's Cancer Care · Anchorage, Alaska
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