Melphalan and Busulfan Followed By Donor Peripheral Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Multiple Myeloma

September 20, 2010 updated by: Fred Hutchinson Cancer Center

A Phase II Study of Intravenous Melphalan and Busulfan Followed by HLA-Matched, Allogeneic Peripheral Blood Stem Cell Transplant for the Treatment of Multiple Myeloma

RATIONALE: Giving chemotherapy, such as melphalan and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and methotrexate before or after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving melphalan together with busulfan followed by donor peripheral stem cell transplant, tacrolimus, and methotrexate works in treating patients with multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Evaluate transplant-related mortality in patients with multiple myeloma treated with a myeloablative conditioning regimen comprising melphalan and busulfan followed by HLA-matched, allogeneic peripheral blood stem cell transplantation (PBSCT) and graft-vs-host disease prophylaxis with tacrolimus and methotrexate.

Secondary

  • Determine the disease response in patients treated with this regimen.
  • Determine the 1-year progression-free survival and overall survival in patients treated with this regimen.

OUTLINE:

  • Conditioning regimen: Patients receive melphalan IV over 30 minutes on day -6 and busulfan IV over 3 hours on days -5 to -3.
  • Peripheral blood stem cell transplantation (PBSCT): Patients undergo HLA-matched, related donor, allogeneic PBSCT on day 0.
  • Graft-versus-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV continuously or orally twice daily beginning on day -2 and continuing until day 80 followed by a taper until day 180 in the absence of GVHD or disease progression. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

After completion of study treatment, patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma

    • Stage I disease with disease progression during the second of ≥ 2 lines of prior therapy

    • Stage II or III disease, meeting 1 of the following criteria:

      • Failed to achieve at least a partial response after ≥ 2 courses of prior therapy
      • Progressive disease after ≥ 2 courses of prior therapy

      • Presented with high-risk features at diagnosis, including any of the following:

        • Cytogenetic abnormality
        • Del 13 or 4,14 by fluorescent in situ hybridization (FISH)
        • Elevated lactic dehydrogenase
        • Beta 2 microglobulin > 5.5
        • Circulating peripheral blood plasma cells
    • Any stage disease with disease progression > 6 months after prior autologous stem cell transplantation

  • Availability of an HLA-matched, related donor between 12 and 75 years of age*

    • No bone marrow donors NOTE: *Donors > 75 years of age are eligible at the discretion of the principal investigator

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Creatinine clearance > 60 mL/min
  • Bilirubin ≤ 2.5 mg/dL
  • ALT/AST < 2 times upper limit of normal
  • Cardiac ejection fraction ≥ 49%
  • DLCO ≥ 50% corrected
  • FEV_1 ≥ 60%
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No cirrhosis
  • No chronic inflammatory or fibrotic liver disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 6 months since prior autologous transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Transplant-related mortality at 180 days

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Overall survival at 1 year
Disease response (complete response)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: William I. Bensinger, MD, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

September 21, 2010

Last Update Submitted That Met QC Criteria

September 20, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018.00
  • FHCRC-2018.00
  • CDR0000467231 (Registry Identifier: PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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