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Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

NCT00028600 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-07-04

No results posted yet for this study

Summary

RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).

PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.

Conditions

Interventions

BIOLOGICAL

filgrastim

PBSC collection: 10 ug/kg/d subQ inj D 5 until completion of collection Auto transpl: 5 ug/kg/d subQ inj D 5 until ANC \>= 1500/uL for 2d or 5000/uL for 1 d Allo transpl: 5ug/kg/d subQ inj D 7 until ANC \> 1000/uL for 3 days Donor pheresis: 10ug/kg/d subQ inj d -5 thru -2

BIOLOGICAL

CD34+ cells

2-8,000,000/kg IV infusion allogeneic transplant 2,000,000/kg IV infusion autologous transplant

DRUG

cyclophosphamide

4g/sq m IV infusion over 1-2 hrs D 1 for auto, and 1g/sq m/d IV infusion over 1 hr on D -4 thru -3 for allo, transplant prep

DRUG

fludarabine phosphate

30mg/sq m/d IVPB over 30 min d -7 thru -3 allo transpl

DRUG

melphalan

200mg/sq m IV infusion over 15-30 min D 2 auto transpl

DRUG

methotrexate

5mg/sq m/d IV infusion D 1,3,\& 6: allo transpl

DRUG

tacrolimus

0.03mg/kg PO bid starting dose, D -1 thru +90, then taper thru D +150

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Kenneth C. Anderson, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2006-06-30
Completion
2010-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT00028600 on ClinicalTrials.gov