Busulfan Plus Melphalan Conditioning Regimen for Lymphoid Malignancies or Multiple Myeloma

NCT00427765 | Completed Phase 2 Results

• 1 other identifier: 2004-0190
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 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. 2.To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this regimen.
3. 3.To determine the disease-free and overall survival of patients receiving this preparative regimen.
4. 4.To determine the treatment-related morbidity and mortality of this combination of drugs.

Conditions

Multiple Myeloma; Lymphoma

Keywords

Multiple Myeloma; Hodgkin's Disease; Non-Hodgkin's Lymphoma; Leukemia; Lymphoma; Busulfan; Melphalan; Autologous bone marrow; BMT; Peripheral blood stem cell transplant; PBSCT

Outcome Measures

Primary Outcomes (1)

• Average Overall Survival Time

  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.

  Baseline(transplantation) to disease progression or death for any reason, up to 6 years.

Study Arms (1)

Busulfan + Melphalan

EXPERIMENTAL

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; Drug: Melphalan

Interventions

Busulfan DRUG

Test Dose = 32 mg/m\^2 IV for 1 Day; 130 mg/m\^2 IV for 4 Days

Also known as: Busulfex

Busulfan + Melphalan

Melphalan DRUG

70 mg/m\^2 IV for 2 Days

Busulfan + Melphalan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Nieto Y, Gruschkus S, Valdez BC, Jones RB, Anderlini P, Hosing C, Popat U, Qazilbash M, Kebriaei P, Alousi A, Saini N, Srour S, Rezvani K, Ramdial J, Barnett M, Gulbis A, Shigle TL, Ahmed S, Iyer S, Lee H, Nair R, Parmar S, Steiner R, Dabaja B, Pinnix C, Gunther J, Cuglievan B, Mahadeo K, Khazal S, Chuang H, Champlin R, Shpall EJ, Andersson BS. Improved outcomes of high-risk relapsed Hodgkin lymphoma patients after high-dose chemotherapy: a 15-year analysis. Haematologica. 2022 Apr 1;107(4):899-908. doi: 10.3324/haematol.2021.278311.

  PMID: 33951890 DERIVED

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Leukemia

Interventions

Busulfan; Melphalan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Partow Kebriaei, MD/Associate Professor
• Organization: UT MD Anderson Cancer Center

celsaenz@mdanderson.org

Study Officials

• Partow Kebriaei, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: December 1, 2004
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 19, 2012
• Results First Posted: January 19, 2012

Record last verified: 2011-12

Locations

US (1)