Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Filgrastim Compared With Sargramostim Plus Chemotherapy, Peripheral Stem Cell Transplantation, and Interferon alfa in Treating Patients With Multiple Myeloma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 70 and under Other UMN-MT-9216 UMN-MT-1992-16, NCT00005987

Objectives

1. Compare disease control and extended survival in patients with multiple myeloma when treated with either filgrastim (G-CSF) or sargramostim (GM-CSF) plus high-dose chemotherapy followed by autologous peripheral blood stem cell (PBSC) transplantation followed by interferon alfa.
2. Determine whether these priming treatments induce sufficient mobilization of circulating PBSC to allow their collection by leukapheresis for subsequent use in autologous transplantation in these patients.
3. Determine whether these treatments induce complete response in conjunction with rapid hematopoietic recovery and modest transplant-associated morbidity and mortality in this patient population.
4. Determine whether interferon alfa, given as maintenance immunostimulatory therapy for patients achieving significant cytoreduction post transplantation, can prevent or delay malignant relapse in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed multiple myeloma
  • Complete or partial remission after initial therapy OR
  • Complete or partial response to therapy after disease progression following initial therapy
  • No plasma cell leukemia (greater than 10% circulating plasma cells)
  • No advanced myeloma refractory and unresponsive to at least 2 salvage chemotherapy regimens

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified

Patient Characteristics:

Age:

• 70 and under

Performance status:

• Age 65-70 years:
  • Karnofsky 80-100%
• Under 65 years:
  • Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 8 g/dL (untransfused)
• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³ (untransfused)

Hepatic:

• Bilirubin less than 2.0 mg/dL
• ALT less than 3 times upper limit of normal

Renal:

• Age 65-70 years:
  • Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
• Under 65 years:
  • Creatinine less than 2 mg/dL

Cardiovascular:

• Age 65-70 years:
  • LVEF at least 45%
• Under 65 years:
  • No active ischemia
  • LVEF greater than 45% by MUGA

Pulmonary:

• Age 65-70 years:
  • If history of smoking or respiratory symptoms, spirometry and DLCO must be greater than 50% of predicted
• Under 65 years:
  • FEV₁ and FVC greater than 60% predicted
  • DLCO greater than 50% of predicted

Other:

• No active or uncontrolled infection

Expected Enrollment

A total of 25-35 patients will be accrued for this study within 2-3 years.

Outline

This is a randomized study. Patients are randomized to one of two treatment arms.

• Arm I: In the priming phase, patients receive cyclophosphamide IV over 2 hours on day 1, mitoxantrone IV over 1 hour daily on days 1-2, and dexamethasone IV every 12 hours beginning on day 1 for a total of 4 doses. Patients also receive sargramostim (GM-CSF) IV over 2 hours or subcutaneously (SC) daily beginning 48 hours after the last dose of mitoxantrone and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected daily on days 11-13 after neutrophil recovery.



• Arm II: In the priming phase, patients receive the same treatment as in arm I except these patients receive filgrastim (G-CSF) IV over 15 minutes or SC in place of GM-CSF.

In the transplant phase, patients who have not received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -6 and -5 and total body irradiation twice daily on days -3 through -1. Autologous PBSC are reinfused on day 0. Patients also receive GM-CSF IV over 2 hours daily and G-CSF IV over 15 minutes daily beginning on day 0 and continuing until day 28 or until blood counts recover.

Patients who have received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -6 through -3, carmustine IV over 1 hour on day -6, and etoposide IV over 4 hours every 12 hours for a total of 6 doses on days -6 through -4. Autologous PBSC are reinfused on day 0. Patients also receive GM-CSF IV over 2 hours daily and G-CSF IV over 15 minutes daily beginning on day 0 and continuing until day 28 or until blood counts recover.

All patients then receive interferon alfa SC 3 times weekly starting on day 28 and continuing until relapse or disease progression.

Patients may also undergo radiotherapy 5 days a week for 2 weeks for residual bony lesions measuring greater than 2 cm.

Patients are followed at days 28 and 100, and at 6, 9, 12, 18, 24, 30, and 36 months.

Trial Contact Information

Trial Lead Organizations

Masonic Cancer Center at University of Minnesota

Daniel Weisdorf, MD, Protocol chair		Ph: 612-624-3101; 888-226-2376 Email: weisd001@umn.edu

Registry Information
Official Title		Autologous Transplantation for Multiple Myeloma: A Research Study of Multiple Myeloma Using Chemotherapy Plus Growth Factor Primed Peripheral Blood Stem Cells Followed by Autologous Transplantation and Post-Transplant Immunotherapy
Trial Start Date		2000-08-15
Registered in ClinicalTrials.gov		NCT00005987
Date Submitted to PDQ		2000-05-12
Information Last Verified		2004-07-16
NCI Grant/Contract Number		CA77598

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