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High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00349778
First Posted: July 10, 2006
Last Update Posted: December 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sally Arai, Stanford University
  Purpose
This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. The study is being performed to evaluate the efficacy and side effects of treatment. Specifically, the study is designed to reduce the risk of interstitial pneumonitis.

Condition Intervention Phase
Multiple Myeloma Drug: Cyclophosphamide Drug: Etoposide Drug: Melphalan Drug: Carmustine Drug: Filgrastim Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Sally Arai, Stanford University:

Primary Outcome Measures:
  • Number of Participants With Pulmonary Toxicity [ Time Frame: 2 years ]
    Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.


Secondary Outcome Measures:
  • Overall Participant Survival (OS) [ Time Frame: 5 years ]
    Survival status was assessed 5 years after transplant.

  • Number of Participants That Relapse After Autologous Transplantation [ Time Frame: 5 years ]
    Relapse was measured as the number of patients who relapse after high-dose sequential therapy then autologous transplantation


Enrollment: 102
Study Start Date: August 2006
Study Completion Date: April 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-Dose Sequential Therapy
Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
Drug: 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
Other Names:
  • Cytoxan
  • Neosar
Drug: Etoposide
100 mg etoposide as 5 mL solution in clear ampules for injection.
Other Names:
  • Etopophos
  • VePesid
  • Toposar
  • VP-16
  • Etoposide phosphate
Drug: 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.
Other Names:
  • Alkeran
  • L-PAM
  • L-Sarcolysin
  • Phenylalanine mustard
Drug: 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.
Other Names:
  • BiCNU
  • BCNU
Drug: 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 Names:
  • Neupogen
  • Granulocyte-colony stimulating factor (G-CSF)

Detailed Description:

Analysis of 196 previously treated patients demonstrated a median event-free survival (EFS) of 36 months with a median overall survival of more than 6 years. The main toxicity of this therapy is related to carmustine-induced pneumonitis or interstitial pneumonitis (IP). This complication is related to the dose of carmustine. Institutional experience in myeloma patients using this dose of carmustine indicates an incidence of IP of34%.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Stage II to III multiple myeloma, or progression after initial treatment of Stage I disease; early or relapsed
  • 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

  • Severe psychological or medical illness
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349778


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sally Arai Stanford University
  More Information

Publications:
Responsible Party: Sally Arai, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00349778     History of Changes
Other Study ID Numbers: IRB-05704
97115 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BMT183 ( Other Identifier: OnCore number )
First Submitted: July 5, 2006
First Posted: July 10, 2006
Results First Submitted: April 26, 2017
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Melphalan
Carmustine
Etoposide phosphate
Etoposide
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic