FM 140 vs FM100 Study in Patients With Multiple Myeloma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00505895
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Melphalan — DRUG
    Arm 1 = 140 mg/m\^2 intravenous over 20 Minutes on Day -1; Arm 2 = 100 mg/m\^2 intravenous over 20 Minutes on Day -1.
  • Fludarabine — DRUG
    30 mg/m\^2 intravenous daily over 30 Minutes for 4 Days (Beginning Day -4).
  • Stem Cell Infusion — PROCEDURE
    Stem Cell Infusion on Day 0.
  • Rituximab — DRUG
    375 mg/m\^2 intravenous on Day -5, +2 +9 and +16.

Study Details

The goal of this clinical research study is to learn if there is a difference in transplant outcomes between two different doses of melphalan given in combination with fludarabine followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma. This study will also look at whether treatment with a antibody called rituximab against a specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host disease after transplant. The safety of these treatments will also be compared.

Key Dates

Start date
Jan 31, 2002
Status verified
Oct 2014
Primary completion
May 31, 2013
Completion
May 31, 2013

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fludarabine + Melphalan + Stem Cell Infusion
    Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.
  • Experimental: Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
    Fludarabine 30 mg/m\^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 intravenous infused starting on day -5.

Primary Outcome Measure

Number of Participants With Successful Engraftment at Day 100 [ Time Frame: Day 100 ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD . Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
UT MD . Anderson Cancer Center· Houston, TX

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