NCT00802568

Brief Summary

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how well it works in treating patients with multiple myeloma that has not responded to treatment.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 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

April 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 16, 2011

Status Verified

December 1, 2008

Enrollment Period

4.1 years

First QC Date

December 4, 2008

Last Update Submit

May 13, 2011

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myelomaosteolytic lesions of multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Mortality rate at 1 year

Interventions

anti-thymocyte globulinBIOLOGICAL
busulfanDRUG
fludarabine phosphateDRUG
allogeneic bone marrow transplantationPROCEDURE
nonmyeloablative allogeneic hematopoietic stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma, meeting 1 of the following criteria: * Stage I disease with a bone lesion * Stage II or III disease meeting any of the following criteria: * Elevated beta-2 microglobulin * Deletion of chromosome 13 * Refractory or relapsed disease * Presence of an evaluable monoclonal component * Must have achieved reduction of primary tumor after receiving prior intensified chemotherapy with high-dose melphalan and cyclosporine with autologous transplantation * HLA identical family donor available * Bone marrow transplantation is allowed in case hematopoietic stem cell collection fails PATIENT CHARACTERISTICS: * Karnofsky 70-100% * No contraindications to allogeneic transplantation * No contraindications to drugs used in conditioning regimen * No psychiatric illness * No other cancer within the past 5 years except basal cell skin cancer or epithelioma in situ of the cervix * No serious and uncontrolled infection * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 1 month since participation in another prior clinical trial

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

Sponsors & Collaborators

Study Sites (1)

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

Antilymphocyte SerumBusulfanfludarabine phosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Didier Blaise, MD

    Institut Paoli-Calmettes

Study Design

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

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 5, 2008

Study Start

April 1, 2007

Primary Completion

May 1, 2011

Last Updated

May 16, 2011

Record last verified: 2008-12

Locations

FR(1)