NCT00313625

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

1.8 years

First QC Date

April 11, 2006

Last Update Submit

September 20, 2010

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Transplant-related mortality at 180 days

Secondary Outcomes (3)

  • Disease response (complete response)

  • Progression-free survival

  • Overall survival at 1 year

Interventions

busulfanDRUG
melphalanDRUG
methotrexateDRUG
tacrolimusDRUG
allogeneic hematopoietic stem cell transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

BusulfanMelphalanMethotrexateTacrolimusPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMacrolidesLactonesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • William I. Bensinger, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 12, 2006

Study Start

September 1, 2005

Primary Completion

July 1, 2007

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(1)