Busulfan Plus Melphalan Conditioning Regimen for Lymphoid Malignancies or Multiple Myeloma

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. Identifier: NCT00427765
Recruitment Status : Completed
First Posted : January 29, 2007
Results First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Primary Objectives:

  1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in adult patients receiving autologous or allogeneic transplantation for lymphoid malignancies or myeloma.
  2. To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this regimen.
  3. To determine the disease-free and overall survival of patients receiving this preparative regimen.
  4. To determine the treatment-related morbidity and mortality of this combination of drugs.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Lymphoma Drug: Busulfan Drug: Melphalan Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of High-Dose Intravenous Busulfan Plus Melphalan With Allogeneic or Autologous Marrow or Peripheral Blood Progenitor Cell Transplantation for Lymphoid Malignancies or Multiple Myeloma
Study Start Date : December 2004
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: Busulfan + Melphalan
Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
Drug: Busulfan
Test Dose = 32 mg/m^2 IV for 1 Day; 130 mg/m^2 IV for 4 Days
Other Name: Busulfex

Drug: Melphalan
70 mg/m^2 IV for 2 Days

Primary Outcome Measures :
  1. Average Overall Survival Time [ Time Frame: Baseline(transplantation) to disease progression or death for any reason, up to 6 years. ]
    Average number of years for survival post transplant where overall survival time is measured from date of transplant to disease progression or death for any reason.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or recurrent), or multiple myeloma (beyond first complete remission or unresponsive to therapy. Complete remission for multiple myeloma defined by absence of detectable paraprotein in serum and/or urine by immunoelectrophoresis or immunofixation, and < 5% plasma cells in the bone marrow), not qualifying for treatment protocols of higher priority.
  • Age 18 to 65 years of age.
  • Adequate renal function as defined by estimated serum creatinine clearance > 50 ml/min and serum creatinine < 1.8 mg/dL.
  • Adequate hepatic function, as defined by serum glutamic pyruvic transaminase (SGPT) < 3 * upper limit of normal; serum bilirubin and alkaline phosphatase < 2 * upper limit of normal, or considered not clinically significant.
  • Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and Capacity of the Lung for Carbon Monoxide (DLCO)> 50%. Exceptions may be allowed for patients with pulmonary involvement after discussing with principal investigator (PI).
  • Adequate cardiac function with left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
  • Zubrod performance score < 2.
  • Patients receiving an allogeneic transplant must have an HLA matched, or one A, B, or DR mismatched related donor. Unrelated donor must be matched at A, B, and DR (defined as A, B serologic matched and DRB1 molecular matched). Donor must be willing to donate peripheral blood or bone marrow progenitor cells.
  • Patient and donor should be willing to participate in the study by providing written consent.
  • Female patient must not be pregnant and have negative pregnancy.

Exclusion Criteria:

  • Patients with unresolved grade >/= 3 non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI.
  • Patients with active Central Nervous System (CNS) disease.
  • Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
  • Uncontrolled infection, including Human immunodeficiency virus (HIV) or Human T-lymphotropic virus Type I (HTLV-1) infection.
  • Patients who have had a previous autologous or allogeneic stem cell transplant during the past year.

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 identifier (NCT number): NCT00427765

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Partow Kebriaei, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00427765     History of Changes
Other Study ID Numbers: 2004-0190
First Posted: January 29, 2007    Key Record Dates
Results First Posted: January 19, 2012
Last Update Posted: January 19, 2012
Last Verified: December 2011

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Autologous bone marrow
Peripheral blood stem cell transplant

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