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A Phase II Study of High Dose Late Intensification Therapy in Patients With Chemotherapy Sensitive Multiple Myeloma

Phase 2
65 Years
Open (Enrolling)
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

A Phase II Study of High Dose Late Intensification Therapy in Patients With Chemotherapy Sensitive Multiple Myeloma

OBJECTIVES: I. Determine the feasibility and activity of intensive therapy with 3 noncross
resistant chemotherapeutic regimens (cyclophosphamide, etoposide, cisplatin, cytarabine, and
tandem courses of high dose melphalan with stem cell rescue) in patients with chemotherapy
sensitive multiple myeloma. II. Determine the incidence of hematologic and nonhematologic
toxicities of this regimen in this patient population. III. Determine the time to
hematologic recovery after high dose melphalan in these patients. IV. Determine the response
rate after each course of therapy in these patients. V. Determine the disease free, relapse
free, and overall survival of these patients treated on this regimen. VI. Determine the
incidence of toxicities attributable to interferon alfa and the ability to continue
interferon alfa therapy as maintenance in these patients.

OUTLINE: Patients are stratified according to the number of prior treatments (1 vs 2).
Patients receive cyclophosphamide IV over 1 hour every 3 hours for 5 doses. Filgrastim
(G-CSF) is administered subcutaneously daily beginning 3 days after cyclophosphamide and
continuing through apheresis. Upon hematologic recovery, peripheral blood stem cells (PBSC)
are collected over several days. After completion of the autologous stem cell harvest and
hematologic recovery, patients receive etoposide IV and cisplatin IV continuously over 4
days, followed by cytarabine IV over 2 hours. Beginning 4-6 weeks later, patients receive
melphalan IV over 15 minutes on 2 consecutive days. At least 48 hours after the second dose
of melphalan, PBSC are reinfused. G-CSF is administered subcutaneously daily beginning 5
days after PBSC reinfusion until hematologic recovery. Patients remaining in remission after
the first course of high dose melphalan receive a second course of melphalan 4 to 6 months
after the first course. Melphalan IV is administered as above with reinfusion of the
remainder of PBSC. After hematologic recovery from the second transplant, patients receive
interferon alfa subcutaneously 3 days weekly until relapse. Patients are followed every 2

PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study within 3 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: All stages of multiple myeloma Measurable disease manifested by
monoclonal serum or urine globulins If nonsecretory, must have malignant plasma cells
documented on bilateral bone marrow biopsy or isolated plasmacytomas Complete remission to
induction chemotherapy allowed No progressive disease after standard induction therapy

PATIENT CHARACTERISTICS: Age: Physiologic 65 and under Performance status: CALGB 0-1 Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than
2.0 mg/dL No active hepatitis with hepatitis C Renal: Creatinine less than 2.0 mg/dL OR
Creatinine clearance at least 50 mL/min Cardiovascular: LVEF at least 45% No history of
symptomatic coronary artery disease unless cleared after cardiology evaluation Pulmonary:
FEV1 at least 60% predicted FEV1/FVC at least 60% Other: HIV negative Hepatitis B surface
antigen negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No more than 2 prior chemotherapy regimens, including induction Endocrine
therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Jane N. Winter, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

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



University of Chicago Cancer Research Center Chicago, Illinois  60637
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611