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Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

This study has been completed.
Information provided by:
Fred Hutchinson Cancer Research Center Identifier:
First received: November 1, 1999
Last updated: June 21, 2011
Last verified: June 2011

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.

Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: busulfan
Drug: melphalan
Drug: thiotepa
Procedure: bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date: November 1997
Study Completion Date: June 2001
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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


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Please refer to this study by its identifier: NCT00003146

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Study Chair: William I. Bensinger, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided Identifier: NCT00003146     History of Changes
Other Study ID Numbers: 1204.00, FHCRC-1204.00, NCI-H97-0007, CDR0000065929
Study First Received: November 1, 1999
Last Updated: June 21, 2011
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 20, 2014