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Interferon Maintenance in Advanced Multiple Myeloma After Using High-Dose Melphalan as Myeloablative Chemotherapy: A Pilot Study


Phase 2
19 Years
64 Years
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Interferon Maintenance in Advanced Multiple Myeloma After Using High-Dose Melphalan as Myeloablative Chemotherapy: A Pilot Study


OBJECTIVES: I. Determine the effectiveness of interferon alfa-2b maintenance following high
dose melphalan chemotherapy for patients with advanced multiple myeloma. II. Determine the
response rate to high dose dexamethasone therapy using sequential noncrossresistant
chemotherapies for patients with advanced multiple myeloma.

OUTLINE: Patients receive high dose dexamethasone on days 1-4, 9-12, and 17-20, followed by
4 weeks rest. Cyclophosphamide (CTX) is administered intravenously in combination with mesna
following dexamethasone therapy. Sargramostim (GM-CSF) is initiated subcutaneously 1 day
later and is continued for 10 days to support stem cell collections, which begin 10-14 days
after CTX induction. Following 4 weeks of rest, melphalan (L-PAM) is administered over 1
hour. Stem cell rescue is begun 48 hours after L-PAM therapy. Three to 4 months after the
first L-PAM course, a second L-PAM and stem cell rescue is undertaken. Interferon alfa-2b
(IFN-A) maintenance is administered 3 times per week following bone marrow recovery from the
first or second L-PAM courses. Patients achieving complete remission following the first
course of L-PAM may proceed directly to IFN-A maintenance. Patients achieving greater than
grade 3 nonhematologic toxicity or not achieving an absolute neutrophil count of greater
than 1,000/mm3 by day 21 posttransplant are not eligible for dose escalation.

PROJECTED ACCRUAL: A minimum of 30 patients will be enrolled.

Inclusion Criteria


DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: Age: 19 to 64 Performance Status: Zubrod 0-3 Hematopoietic: Not
specified Hepatic: Bilirubin less than 2 mg/dL SGOT and SGPT less than 3 times normal
Alkaline phosphatase less than 3 times normal Renal: Creatinine clearance at least 60
mL/min Cardiovascular: Cardiac ejection fraction at least 50% Pulmonary: No history of
severe chronic obstructive lung disease No history of recurrent pulmonary emboli Other:
Not pregnant or nursing Effective contraception should be practiced by fertile patients No
history of diabetes mellitus complicated by ketoacidosis No history of depression or
psychosis No history of autoimmune disorders No concurrent thyroid disorders unable to be
maintained on replacement therapy No prior hypersensitivity to interferon alfa-2b

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 12
months of prior alkylator therapy Endocrine Therapy: Not specified Radiotherapy: Not
specified Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Clyde M. Jones, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Tennessee Cancer Institute at St. Francis Hospital - Park Avenue

Authority:

United States: Federal Government

Study ID:

UTENNM-BCG-5889

NCT ID:

NCT00003007

Start Date:

July 1996

Completion Date:

January 2004

Related Keywords:

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

Name

Location

Baptist Memorial HospitalMemphis, Tennessee  38146
Methodist Healthcare - Hospital of MemphisMemphis, Tennessee  38104
University of Tennessee, MemphisMemphis, Tennessee  38163
William F. Bowld HospitalMemphis, Tennessee  38103