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A Phase II Study of Total Marrow Irradiation, Busulfan, and Alpha-Interferon Followed by Allogeneic Peripheral Blood Stem Cell or Marrow Transplantation for Treatment of Patients With Advanced Multiple Myeloma.


Phase 2
18 Years
65 Years
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A Phase II Study of Total Marrow Irradiation, Busulfan, and Alpha-Interferon Followed by Allogeneic Peripheral Blood Stem Cell or Marrow Transplantation for Treatment of Patients With Advanced Multiple Myeloma.


OBJECTIVES: I. Evaluate the effects of total marrow irradiation and busulfan followed by
allogeneic peripheral blood stem cell or marrow transplantation on the outcomes of treatment
related mortality, response, relapse, survival, and event free survival for patients with
advanced multiple myeloma.

OUTLINE: Peripheral blood stem cell (PBSC) or bone marrow (BM) collection and infusion are
performed according to standard practice. Patients undergo total marrow irradiation (TMI)
bid for 3 days. Busulfan is administered every 6 hours on days -6 to -3. PBSC or BM is
infused on day 0. Interferon alfa is administered subcutaneously on Mondays, Wednesdays, and
Fridays beginning on day 80. Interferon therapy may continue in the absence of graft versus
host disease or disease progression. Patients are followed on days 56 and 84, then every 6
months for 2 years, and annually thereafter.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued over 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically diagnosed stage II or III multiple myeloma Stage I
multiple myeloma progressing on conventional therapy HLA matched donor Related - ages
18-65 Unrelated - ages 18-55

PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: No significant hepatic
disease Bilirubin no greater than 2 mg/dL Renal: Creatinine clearance at least 40 mL/min
Calcium no greater than 15 mg/dL Cardiovascular: No significant cardiac disease Ejection
fraction at least 40% Pulmonary: No significant pulmonary disease FEV1 at least 50% OR
DLCO at least 50% Other: No obesity Chest wall no greater than 3 cm thick No pendulous
breasts HIV negative

PRIOR CONCURRENT THERAPY: Must have received prior conventional therapy for stage I
disease

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:

1272.00

NCT ID:

NCT00003195

Start Date:

December 1997

Completion Date:

November 2000

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory 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