Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03346135
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Plasma Cell Myeloma
  • Secondary Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo standard of care ASCT with a conditioning regimen of melphalan
  • Daratumumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Melphalan — DRUG
    Undergo standard of care ASCT with a conditioning regimen of melphalan

Study Details

This phase II trial studies how well daratumumab after a stem cell transplant works in treating patients with multiple myeloma. Monoclonal antibodies, such as daratumumab, may kill cancer cells that are left after chemotherapy.

Key Dates

Start date
Jul 17, 2019
Status verified
Dec 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

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

Arms

  • Experimental: Treatment (ASCT, melphalan, daratumumab)
    Patients undergo standard of care ASCT with a conditioning regimen of melphalan. Beginning 60-120 days after ASCT, patients receive daratumumab IV every week for 8 weeks, every 2 weeks for 16 weeks, and then every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free survival [ Time Frame: From date of first dose of study drug to first documented date of disease relapse, progression, or death (from any cause), whichever occurs first, assessed for up to 18 months after last dose of study drug ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
Sarah Cannon Cancer CenterNashvilleTennessee37203-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CASarah Cannon Cancer Center· Nashville, TN

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