Clinical trial · Interventional
Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
A Study of Outcomes and Toxicity of Busulfex as Part of a High Dose Chemotherapy Preparative Regimen in Autologous Hematopoietic Stem Cell Transplantation for Patients With Plasma Cell Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Busulfan Treatment
- interventionNames
- Drug: busulfan
- Drug: cyclophosphamide
- Procedure: autologous hematopoietic stem cell transplantation
Primary outcomes (2)
- measure
- Relapse-free Survival
- timeFrame
- at 6 months
- description
- 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 .
- measure
- Overall Survival
- timeFrame
- at 6 months
- description
- Number of patients alive at the end of the study period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available