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NCT Number: NCT00349778

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

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

etoposide

Drug

100 mg etoposide as 5 mL solution in clear ampules for injection.

Other names: Etopophos, VePesid, Toposar, VP-16, Etoposide phosphate

melphalan

Drug

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

carmustine

Drug

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

Filgrastim

Drug

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)

Primary outcomes

  1. Number of Participants With Pulmonary Toxicity

    Time frame: 2 years

    Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.

Secondary outcomes

  1. Overall Participant Survival (OS)

    Time frame: 5 years

    Survival status was assessed 5 years after transplant.

  2. 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Jul 10, 2006
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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