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Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma

NCT00185614 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-01-18

Study results available
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Summary

Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.

Conditions

Interventions

PROCEDURE

Autologous hematopoietic cell transplant (Auto-HCT)

The target cell dose is 2.6 x 10e6 CD34+ cells/kg

PROCEDURE

Allogeneic hematopoietic cell transplant (Allo-HCT)

The target cell dose is 5 x 10e6 CD34 cells/kg

DRUG

Cyclophosphamide

Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion

DRUG

Filgrastim

* Filgrastim 10 µg/kg/day to mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion (Auto-HCT) * Filgrastim 5 µg/kg/day starting 6 days after melphalan (Day 4 after Auto-HCT) * Filgrastim 16 µg/kg/day to mobilize donor peripheral blood progenitor cells (PBPC) for allogeneic transplant (Allo-HCT)

DRUG

Melphalan

Melphalan 200 mg/m2 (high-dose) intravenously as conditioning for Auto-HCT

RADIATION

Total body irradiation (TBI)

200 centigray (cGy) total body irradiation delivered on Day 0

PROCEDURE

Cyclosporine (CSP)

Cyclosporine administered twice-daily by mouth at a dose of 6.25 mg/kg from Day -3 through Day 56

DRUG

Mycophenolate Mofetil (MMF)

Mycophenolate mofetil will begin at 15 mg/kg twice-daily by mouth from Day 0 to Day 27

Sponsors & Collaborators

  • Wen-Kai Weng

    lead OTHER

Principal Investigators

  • Wen-Kai Weng, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-08-31
Primary Completion
2009-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00185614 on ClinicalTrials.gov