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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


Phase 2
N/A
70 Years
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William I. Bensinger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1204.00

NCT ID:

NCT00003146

Start Date:

November 1997

Completion Date:

June 2001

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109