Back to resultsCombination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma and Plasma Cell Neoplasm
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
busulfan
melphalan
thiotepa
bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically diagnosed stage II/III multiple myeloma (or have greater than normal beta-2-microglobulin) meeting the Salmon and Durie criteria Stage I multiple myeloma must have had prior chemotherapy before undergoing transplantation PATIENT CHARACTERISTICS: Age: 70 and under Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine clearance at least 50 mg/min Cardiovascular: Left ventricular ejection fraction at least 41% Other: Not pregnant HIV negative PRIOR CONCURRENT THERAPY: Not specified
Sites / Locations
- Fred Hutchinson Cancer Research Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00003146
First Posted
November 1, 1999
Last Updated
June 21, 2011
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00003146
Brief Title
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Official Title
A Phase II Trial of Thiotepa, Busulfan, and Melphalan Followed by Autologous or Syngeneic Marrow or Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 1997 (undefined)
Primary Completion Date
June 2001 (Actual)
Study Completion Date
June 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with multiple myeloma.
Detailed Description
OBJECTIVES: I. Assess the toxicity and efficacy at the maximum tolerated dose of busulfan, melphalan, and thiotepa in patients with multiple myeloma.
OUTLINE: This is a single arm, open label study. Peripheral blood stem cells (PBSC) are collected and cryopreserved, or bone marrow is harvested and stored, until infusion on day 0. Patients receive oral busulfan every 6 hours on days -8, -7, and -6. Melphalan is administered by continuous IV infusion over 30 minutes on days -5 and -4. Thiotepa is administered by continuous IV infusion over 2 hours on days -3 and -2. Patients undergo PBSC or bone marrow infusion 36-48 hours following the completion of chemotherapy (day 0). Patients are followed for 100 days posttransplant and every 3 months thereafter.
PROJECTED ACCRUAL: 30 patients will be accrued.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Drug
Intervention Name(s)
thiotepa
Intervention Type
Procedure
Intervention Name(s)
bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
10. Eligibility
Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically diagnosed stage II/III multiple myeloma (or have greater than normal beta-2-microglobulin) meeting the Salmon and Durie criteria Stage I multiple myeloma must have had prior chemotherapy before undergoing transplantation
PATIENT CHARACTERISTICS: Age: 70 and under Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine clearance at least 50 mg/min Cardiovascular: Left ventricular ejection fraction at least 41% Other: Not pregnant HIV negative
PRIOR CONCURRENT THERAPY: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William I. Bensinger, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
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