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

NCT ID: NCT00313625

Last Updated: 2010-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma and Plasma Cell Neoplasm

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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busulfan

Intervention Type DRUG

melphalan

Intervention Type DRUG

methotrexate

Intervention Type DRUG

tacrolimus

Intervention Type DRUG

allogeneic hematopoietic stem cell transplantation

Intervention Type PROCEDURE

peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Fred Hutchinson Cancer Research Center

Principal Investigators

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William I. Bensinger, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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FHCRC-2018.00

Identifier Type: -

Identifier Source: secondary_id

CDR0000467231

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018.00

Identifier Type: -

Identifier Source: org_study_id