Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma

Sponsor
Washington University School of Medicine
Study ID
NCT02447055
Phase
EARLY_PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — BIOLOGICAL
  • Melphalan — DRUG
  • Fludarabine — DRUG
  • Cyclophosphamide — DRUG
  • Tacrolimus — DRUG
  • Mycophenolate mofetil — DRUG
  • Filgrastim — DRUG

Study Details

The purpose of this study is to develop a novel platform for allo-SCT in multiple myeloma (MM) with the idea of maximizing anti-myeloma effect with conditioning and minimizing GvHD (graft versus host disease). Specifically, the investigators will use the Flu/Mel (fludarabine and melphalan) regimen. For GvHD prophylaxis, the investigators use the Hopkins PT-Cy (post-transplant cyclophosphamide) platform with the novelty of adding tocilizumab as both an anti-myeloma therapy and as a method to reduce GvHD. IL-6 has an important role in promoting the growth of myeloma cells and progression of disease.

Key Dates

Start date
Dec 31, 2015
Status verified
Jul 2016
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016

Study Design

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

Arms

  • Experimental: Arm 1 (Flu/Mel/PT-Cy & Tac/MMF for certain cases)
    * Fludarabine 30 mg/m\^2 intravenously (IV) on Days -5, -4, -3, and -2 * Melphalan 140 mg/m\^2 IV on Day -2 * Tocilizumab 8 mg/m\^2 (capped at 800 mg) IV on Day -1 * Stem cell infusion on Day 0 * Cyclophosphamide 50 mg/kg IV on Days +3 and +4 * Tacrolimus 1 mg/day IV on Day +5 (for unrelated \& haploidentical cases) * Mycophenolate mofetil 15 mg/kg orally three times per day on Day +5 (for unrelated \& haploidentical cases) * Filgrastim 10 ug/kg/day subcutaneously until neutrophil recovery starting on Day +5

Primary Outcome Measure

Safety and tolerability of regimen as measured by grade and frequency of adverse events [ Time Frame: Day +100 ]

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