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Total-Body Irradiation, Busulfan, and Interferon Alfa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00003195
First received: November 1, 1999
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.

PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, busulfan, and interferon alfa followed by peripheral stem cell or bone marrow transplantation in treating patients with multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Biological: recombinant interferon alfa
Drug: busulfan
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


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

Study Start Date: December 1997
Study Completion Date: November 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003195

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003195     History of Changes
Other Study ID Numbers: 1272.00, FHCRC-1272.00, NCI-H98-0009, CDR0000066030
Study First Received: November 1, 1999
Last Updated: November 15, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Busulfan
Interferon-alpha
Interferons
Alkylating Agents
Anti-Infective Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014