Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma

Case Comprehensive Cancer Center71 enrolled

Overview

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide followed by an autologous stem cell transplant works in treating patients with multiple myeloma.

OBJECTIVES: Primary * To compare relapse-free survival and overall survival of patients with multiple myeloma treated with IV busulfan vs historical control patients treated with oral busulfan when administered with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem cell transplantation. Secondary * To compare pulmonary toxicity rates of IV busulfan vs oral busulfan when administered with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem cell transplantation. OUTLINE: Patients receive high-dose busulfan IV every 6 hours on days -8 to -4 and high-dose cyclophosphamide IV over 4 hours on days -3 and -2. Patients undergo autologous hematopoietic stem cell transplantation on day 0. After completion of study treatment, patients are followed up periodically.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Interventions

busulfanDRUG

IV busulfan 0.8 mg/kg every 6 hours x 16 doses

cyclophosphamideDRUG

IV cyclophosphamide 60 mg/kg over 4 hours x 2 days

autologous hematopoietic stem cell transplantationPROCEDURE

infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

INCLUSION CRITERIA: * Patients with a diagnosis of plasma cell myeloma * Patients with cardiac ejection fraction \>= 45% or clearance by Cleveland Clinic Faculty (CCF) cardiologist * Patients with diffusion capacity of carbon monoxide (DLCO) \>= 45% predicted or clearance by CCF pulmonologist * Patient with previously harvested peripheral blood progenitor cells with a minimum of 2 x 10\^6 CD 34+ cells/kg harvested EXCLUSION CRITERIA: * Patients receiving total body irradiation * Non-myeloablative/reduced-intensity conditioning * Pregnant and breast feeding patients * Human immunodeficiency virus (HIV) positive * Patients with serum creatinine \> 2.0 * Prior Hematopoietic Stem Cell (HSC) transplant

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Relapse-free Survival

Number of participants without progressive disease at the end of the study period, using the definitions for complete response, partial response and progressive disease from the International Myeloma Working Group .

Time frame: at 6 months

Overall Survival

Number of patients alive at the end of the study period

Time frame: at 6 months

Secondary Outcomes

Pulmonary Toxicity

Toxicity criteria will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) v3.0. Estimated using exact 95% binomial confidence intervals.

Time frame: At 6 months

Data from ClinicalTrials.gov

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