High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
NCT ID: NCT00349778
Last Updated: 2017-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2006-08-31
2010-04-30
Brief Summary
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Detailed Description
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There have been recent studies evaluating the role of tandem autologous transplants for patients with multiple myeloma. These trials were based upon the hypothesis that performing tandem high-dose therapy regimens would lead to increased tumor cell kill, decreased tumor burden and an improvement in overall survival. Our results with high-dose sequential therapy including the dose-intense carmustine/melphalan transplant demonstrates similar median EFS and overall survival (OS) when compared with the results of tandem transplant approaches.The proposed trial will continue to use a high-dose sequential transplant approach, however, we will use a reduced dose of carmustine which we expect to be associated with a lower incidence of IP.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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High-Dose Sequential Therapy
Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
Cyclophosphamide
Cyclophosphamide as a white powder in 100 mg, 200 mg and 500 mg vials, to be dissolved in \~250 mL of saline or D5W and infused IV over 2 hours
Etoposide
100 mg etoposide as 5 mL solution in clear ampules for injection.
Melphalan
Melphalan as single-use glass vials of freeze-dried melphalan hydrochloride (equivalent to 50 mg of melphalan), to be reconstituted in 0.9% sodium chloride solution to not greater than 0.45 mg/mL, and administered within 1 hour of constitution.
Carmustine
Carmustine as a powder for reconstitution in 100 mg vials, to be reconstituted with 3 mL sterile dehydrated ethanol and D5W. Carmustine should be dissolved in 500 mL of 5% dextrose in water (D5W) and infused IV over 2 hours.
Filgrastim
Filgrastim in vials of 300 µg or 480 µg at a concentration of 300 µg/mL, to be given as a daily subcutaneous injection.
Interventions
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Cyclophosphamide
Cyclophosphamide as a white powder in 100 mg, 200 mg and 500 mg vials, to be dissolved in \~250 mL of saline or D5W and infused IV over 2 hours
Etoposide
100 mg etoposide as 5 mL solution in clear ampules for injection.
Melphalan
Melphalan as single-use glass vials of freeze-dried melphalan hydrochloride (equivalent to 50 mg of melphalan), to be reconstituted in 0.9% sodium chloride solution to not greater than 0.45 mg/mL, and administered within 1 hour of constitution.
Carmustine
Carmustine as a powder for reconstitution in 100 mg vials, to be reconstituted with 3 mL sterile dehydrated ethanol and D5W. Carmustine should be dissolved in 500 mL of 5% dextrose in water (D5W) and infused IV over 2 hours.
Filgrastim
Filgrastim in vials of 300 µg or 480 µg at a concentration of 300 µg/mL, to be given as a daily subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 to 75 years.
* Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
* Patients with amyloidosis may be eligible for this trial, with approval by the Principle Investigator.
* Patients must have a Karnofsky performance status \> 70%.
* Aspartate aminotransferase (AST) must be \< 2 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) must be \< 2 x ULN
* Total bilirubin \< 2 mg/dL.
* Serum creatinine \< 2.0 or 24-hour creatinine clearance ≥ 60 mL/min.
* Patients must be HIV-negative.
* Patients must provide signed, informed consent.
Exclusion Criteria
* Prior autologous hematopoietic cell transplantation
* Pregnant
* Lactating women
* Smoldering multiple myeloma,
* Monoclonal gammopathy of unknown significance or primary amyloidosis will be excluded from this study
18 Years
75 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Sally Arai
Assistant Professor of Medicine
Principal Investigators
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Sally Arai
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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References
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Chen AI, Negrin RS, McMillan A, Shizuru JA, Johnston LJ, Lowsky R, Miklos DB, Arai S, Weng WK, Laport GG, Stockerl-Goldstein K. Tandem chemo-mobilization followed by high-dose melphalan and carmustine with single autologous hematopoietic cell transplantation for multiple myeloma. Bone Marrow Transplant. 2012 Apr;47(4):516-21. doi: 10.1038/bmt.2011.106. Epub 2011 May 23.
Other Identifiers
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97115
Identifier Type: OTHER
Identifier Source: secondary_id
BMT183
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-05704
Identifier Type: -
Identifier Source: org_study_id