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Stem Cell Transplant as Standard Therapy for Symptomatic Multiple Myeloma


Phase 3
N/A
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

Stem Cell Transplant as Standard Therapy for Symptomatic Multiple Myeloma


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ann Traynor, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 97H6T

NCT ID:

NCT00004165

Start Date:

October 1999

Completion Date:

August 2003

Related Keywords:

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

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611