Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

Stem Cell Transplant as Standard Therapy for Symptomatic Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004165
• Other study ID #: NU 97H6T
• Secondary ID: NU-97H6TNCI-G99-
• Status: Completed
• Phase: Phase 3
• First received: December 10, 1999
• Last updated: May 31, 2012
• Start date: October 1999
• Est. completion date: August 2003

Study information

• Verified date: May 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase III trial to study the effectiveness of melphalan followed by peripheral stem cell transplantation in treating patients who have multiple myeloma.

Description:

OBJECTIVES:

• Administer standard, high dose melphalan safely in a closely monitored setting in patients with responsive multiple myeloma.

• Determine the cost and time effectiveness in the collection of sufficient peripheral blood stem cells (PBSC) for two high dose melphalan therapies and PBSC transplantations in this patient population.

OUTLINE: Patients not in remission receive 3-6 courses of remission induction therapy consisting of either an anthracycline/glucocorticoid regimen or high dose glucocorticoids.

At 21-45 days following induction therapy, patients receive filgrastim (G-CSF) subcutaneously daily for 4 days followed by daily peripheral blood stem cell (PBSC) collection beginning on day 4 and continuing until the target number of cells is reached.

At 5 days to 6 weeks following PBSC collection, patients receive high dose melphalan IV over 2 hours for 2 consecutive days. At 36-48 hours following completion of melphalan, patients receive infusion of PBSC followed by G-CSF subcutaneously daily until blood counts recover.

At 3 months to 5 years following high dose therapy and PBSC infusion, patients with evidence of disease progression receive an additional treatment with high dose melphalan followed by PBSC infusion as in the first course.

Patients are followed at 30-45 days, 6 months, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60-120 patients will be accrued for this study over 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosed active multiple myeloma defined by:

• Lytic disease

• Anemia

• Hypercalcemia

• Secondary renal insufficiency

• More than 400 mg/24 hours of urinary protein excretion

• Symptomatic hyperviscosity

• If previously treated, refractory to no more than 1 regimen

• Primary amyloidosis without subsequent multiple myeloma allowed

• Abnormal renal function allowed if due to primary disease

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• See Disease Characteristics

• Creatinine clearance greater than 50 mL/min if no renal impairment

Cardiovascular:

• No cardiac function that would preclude study

• LVEF greater than 45%

Pulmonary:

• No pulmonary function that would preclude study

• FVC greater than 60% predicted

• DLCO greater than 50% predicted

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No greater than 18 months of prior alkylator exposure

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• See Disease Characteristics

• No more than 3 prior treatment regimens allowed

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Biological:
• filgrastim

Drug:
• melphalan

Procedure:
• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,