Testing the Investigational Agent Combination of Daratumumab, Bortezomib, and Dexamethasone Compared to the Usual Treatment of Cyclophosphamide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients With Kidney Failure

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Eastern Cooperative Oncology Group
Study ID
NCT07085728
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Myeloma Multiple

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Arm A
  • Bortezomib (VELCADE) — DRUG
    Arm A, Arm B
  • Dexamethasone — DRUG
    Arm A, Arm B
  • Daratumumab-hyaluronidase — DRUG
    Arm B

Study Details

This study is being done to answer the following question: Can the addition of daratumumab-hyaluronidase to the usual treatment of bortezomib and dexamethasone improve kidney function in patients who are newly diagnosed with multiple myeloma and have kidney failure? This study is being done because the investigators want to find out if this approach is better or worse than the usual approach for the participant's newly diagnosed multiple myeloma. The usual approach is defined as care most people get for multiple myeloma. If the participant decides to take part in this study, they will either get the study medications daratumumab-hyaluronidase, bortezomib, and dexamethasone for four months (4 cycles), or the typical medications used to treat your cancer (cyclophosphamide, bortezomib, and dexamethasone) for 4 months (4 cycles). After the participant finishes their study treatment, their doctor will continue to follow their condition for 10 years to watch them for side effects and monitor their disease status. Their doctor will follow up with them every 3 months for years 1 and 2 and then every 6 months for years 3 through 10.

Key Dates

Start date
Aug 11, 2025
Status verified
May 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ARM A (Cy-Bor-Dex)
    Cyclophosphamide-Bortezomib-Dexamethasone (4 cycles)
  • Experimental: ARM B (Dara-Bor-Dex)
    Daratumumab-Bortezomib-Dexamethasone

Primary Outcome Measure

Renal Response Rate [ Time Frame: Assessed every cycle on treatment up to 4 cycles (cycle duration=28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Alaska Oncology and Hematology LLCAnchorageAlaska99508-

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By research site
Alaska Oncology and Hematology LLC· Anchorage, AK

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