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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 10, 2006
Last Update Posted: October 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:
Stanford University
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: BCNU Melphalan Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 Stanford University:

Primary Outcome Measures:
  • Evaluate the risk of interstitial pneumonitis with the current dosing of BCNU and melphalan [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Remission rate, event-free survival, overall survival and relapse [ Time Frame: 2 years ]

Estimated Enrollment: 49
Study Start Date: August 2006
Study Completion Date: April 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Detailed Description:

We have performed over 200 autologous HCT for myeloma at Stanford using high-dose sequential therapy with a BCNU dose of 550 mg/m2 plus melphalan 200 mg/m2. Analysis of 196 patients treated this way demonstrates a median event-free survival of 36 months with a median overall survival of more than six years. The main toxicity of this therapy is related to BCNU-pneumonitis or interstitial pneumonitis (IP). This complication is related to the dose of BCNU and is well described in the literature(18). In our myeloma patients treated with this dose of BCNU the incidence of IP is 34%.

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(9, 19). There are trials comparing single to double transplants that suggest there may be a benefit for tandem autologous transplants for event-free survival and overall survival (20-22). However, our results with high-dose sequential therapy including the dose-intense BCNU/Melphalan transplant demonstrates similar median event-free survival and overall survival 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 BCNU which we expect to be associated with a lower incidence of IP.


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

Inclusion Criteria:- Multiple myeloma. Eligible patients may have early or relapsed disease. Patients must have Stage II-III disease or have progression after initial treatment of Stage I disease.

  • Age 18-75 years.
  • Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. Patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or primary amyloidosis will be excluded from this study. Patients with multiple myeloma and amyloidosis may be eligible for this trial, with approval by the Principle Investigator.
  • Patients must have a Karnofsky performance status > 70%.
  • DLCO >=60% predicted.
  • ALT and AST must be < 2X normal. Total bilirubin less than 2 mg/dl.
  • Serum creatinine < 2.0 or 24-hour creatinine clearance e 60 ml/min.
  • Patients must be HIV negative.
  • Pregnant or lactating women will not be eligible to participate.
  • Patients must provide signed, informed consent.

Exclusion Criteria:- Severe psychological or medical illness

- Patients who have undergone prior autologous hematopoietic cell transplantation will not be eligible for 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

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

Responsible Party: Sally Arai, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00349778     History of Changes
Other Study ID Numbers: BMT183
First Submitted: July 5, 2006
First Posted: July 10, 2006
Last Update Posted: October 12, 2017
Last Verified: October 2010

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
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
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors