Daratumumab-Based Therapy for the Treatment of Newly Diagnosed Multiple Myeloma With Kidney Failure

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04352205
Phase
PHASE2
Status
Terminated

Conditions

  • Plasma Cell Myeloma
  • Renal Failure

Eligibility Criteria

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

Interventions

  • Bortezomib — DRUG
    Given SC
  • Daratumumab — BIOLOGICAL
    Given IV
  • Dexamethasone — DRUG
    Given PO and IV
  • Lenalidomide — DRUG
    Given PO
  • Thalidomide — DRUG
    Given PO

Study Details

This phase II trial studies how well daratumumab-based therapy works in treating patients with newly diagnosed multiple myeloma with kidney failure. Daratumumab-based therapy includes daratumumab, bortezomib, dexamethasone, and thalidomide or lenalidomide. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Bortezomib is a drug that prevents myeloma cells from getting rid of their waste products, leading to being targeted for death. Dexamethasone is a steroid that is commonly used, either alone or in combination with other drugs, to treat multiple myeloma. Lenalidomide and thalidomide may stop the growth of multiple myeloma by blocking the growth of new blood vessels necessary for tumor growth. Giving daratumumab, bortezomib, dexamethasone, and thalidomide or lenalidomide may be a good way to treat patients with newly diagnosed multiple myeloma with kidney failure.

Key Dates

Start date
May 7, 2020
Status verified
Jun 2024
Primary completion
Jan 19, 2024
Completion
Jan 19, 2024

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (daratumumab-based treatment)
    Patients receive daratumumab IV weekly of cycles 1-3 and on day 1 only of cycle 4, bortezomib SC on days 1, 4, 8, and 11, and dexamethasone IV or PO on days 1-4 of cycle 1 and on day 1 of cycles 2-4 and PO on days 8 and 15 of all cycles. Beginning cycle 2, patients may also receive lenalidomide PO daily on days 1-14 or thalidomide PO QD on days 1-21. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Change in creatinine clearance [ Time Frame: Screening until end of Cycle 4 at day 1(12 weeks), each cycle=21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-

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Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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