NCT00004181

Brief Summary

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation in treating patients who have multiple myeloma, chronic phase chronic myelogenous leukemia, or agnogenic myeloid metaplasia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1999

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2000

Completed
3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

4.8 years

First QC Date

January 21, 2000

Last Update Submit

June 8, 2012

Conditions

Chronic Myeloproliferative DisordersLeukemiaMultiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomachronic phase chronic myelogenous leukemiachronic idiopathic myelofibrosisPhiladelphia chromosome positive chronic myelogenous leukemia

Interventions

busulfanDRUG
cyclophosphamideDRUG
allogeneic bone marrow transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Cytologically proven disease of one of the following types with transfusion-dependent anemia or thrombocytopenia (less than 50,000/mm\^3): * Multiple myeloma * Agnogenic myeloid metaplasia * Chronic myelogenous leukemia in first or second chronic phase * Philadelphia chromosome with BCR gene rearrangement * Suitable sibling bone marrow donor available PATIENT CHARACTERISTICS: Age: * 15 to physiologic 55 Performance status: * ECOG 0 or 1 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT less than 2 times normal * Alkaline phosphatase less than 2 times normal Renal: * Creatinine less than 2 mg/dL Cardiovascular: * Ejection fraction normal by MUGA * No acute myocardial infarction within the past 6 months * No active angina pectoris * No active congestive heart failure Pulmonary: * FEV greater than 50% predicted * DLCO at least 50% Other: * HIV negative * No active infection * No concurrent organ damage or medical problems that would preclude therapy PRIOR CONCURRENT THERAPY: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaMultiple MyelomaNeoplasms, Plasma CellLeukemia, Myeloid, Chronic-PhasePrimary MyelofibrosisLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

BusulfanCyclophosphamideRadiotherapy

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsTherapeutics

Study Officials

  • Martin S. Tallman, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2000

First Posted

January 27, 2003

Study Start

October 1, 1999

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

US(1)