Completed

Stem Cell Transplant as Standard Therapy for Symptomatic Multiple Myeloma

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What is being tested

filgrastim

+ melphalan

+ peripheral blood stem cell transplantation

BiologicalDrugProcedure
Who is being recruted

Amyloidosis+17

+ Blood Protein Disorders

+ Cardiovascular Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 1999
See protocol details

Summary

Principal SponsorNorthwestern University
Last updated: June 6, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00004165
Principal SponsorNorthwestern University
Last updated: June 6, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AmyloidosisBlood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersMetabolic DiseasesNeoplasmsNeoplasms by Histologic TypeNutritional and Metabolic DiseasesParaproteinemiasVascular DiseasesHemostatic DisordersProteostasis DeficienciesImmunoglobulin Light-chain AmyloidosisMultiple MyelomaNeoplasms, Plasma Cell

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, United StatesOpen Robert H. Lurie Comprehensive Cancer Center, Northwestern University in Google Maps
CompletedOne Study Center
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