Phase 2 Completed N=71 Treatment

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

Multiple Myeloma

Source: ClinicalTrials.gov NCT00941720 ↗

Enrolled (actual)

Serious AEs

21.1%

Results posted

Apr 2014

Primary outcomePrimary: Relapse-free Survival — 48 participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Relapse-free Survival	48	—
PRIMARY Overall Survival	53	—
SECONDARY Pulmonary Toxicity	3.5	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00941720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.