Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT03477539
Phase
PHASE2
Status
Completed

Conditions

  • Plasma Cell Myeloma

Eligibility Criteria

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

Interventions

  • Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo ASCT
  • Daratumumab — BIOLOGICAL
    Given IV
  • Lenalidomide — DRUG
    Given PO

Study Details

This phase II trial studies how well daratumumab works in treating transplant-eligible patients with multiple myeloma. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.

Key Dates

Start date
Apr 9, 2018
Status verified
Jan 2026
Primary completion
May 11, 2022
Completion
Mar 24, 2025

Study Design

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

Arms

  • Experimental: Treatment (daratumumab, ASCT, lenalidomide)
    CONSOLIDATION I: Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION II: Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. MAINTENANCE: Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Rate of Minimal Residual Disease (MRD) Negative Response After Autologous Stem Cell Transplantation (ASCT) [ Time Frame: 100 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-

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Mayo Clinic in Florida· Jacksonville, FL

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