Clinical trial · Interventional
High Dose Busulfan and Bortezomib in Treating Patients With High Risk Multiple Myeloma Undergoing Stem Cell Transplant
A Pilot Study Using High Dose Busulfan and Bortezomib as Part of Allogeneic Transplant Conditioning Regimen for High Risk Multiple Myeloma Patients.
NCT01534143CI-TRIAL-00026809terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Data was not collected, because funding was unavailable to continue study.
Summary
Brief summary (as posted)
This pilot phase II trial studies how well giving high dose busulfan together with bortezomib works in treating patients with high risk multiple myeloma undergoing stem cell transplant. Drugs used in chemotherapy, such as busulfan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cells growth. Giving busulfan together with bortezomib before a stem cell transplant may kill more cancer cells
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage III Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage II Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage I Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| bortezomib | Drug | Bortezomib | ALIAS |
| busulfan | Drug | Busulfan | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy, enzyme inhibitor)
- description
- CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2. GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
- interventionNames
- Other: pharmacological study
- Drug: tacrolimus
- Drug: sirolimus
- Biological: anti-thymocyte globulin
- Drug: fludarabine phosphate
- Drug: busulfan
- Drug: bortezomib
- Procedure: allogeneic hematopoietic stem cell transplantation
- Other: laboratory biomarker analysis
Primary outcomes (4)
- measure
- Incidence and Severity of Acute GVHD Using Fludarabine Phosphate / Busulfan / Bortezomib Preparative Regimen and Triple Immune Suppression With Tacrolimus, Sirolimus and Anti-thymocyte Globulin
- timeFrame
- First 6 months post-transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to provide informed consent * Karnofsky Performance Status (KPS) \>= 70 * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Availability of a suitable allogeneic hematopoietic stem cell donor; minimum of human leukocyte antigen (HLA) 7/8 matched related or unrelated donor * High risk multiple myeloma with poor prognostic features based on having one or more of the following criteria: * Progressive disease after autologous transplant. No less than 3 months post auto transplant * Progressive or stable disease after induction chemotherapy using the most potent myeloma agents Lenalidomide and/or Bortezomib * Patients with high risk cytogenetic abnormalities documented on conventional cytogenetics or fluorescence in situ hybridization (FISH) (hypodiploidy, t(4:14), t(14:16) chromosome translocation, p53 and or complex cytogenetics) additionally, chromosome 13 deletion by standard cytogenetics * Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test for women, as well as implementation of birth control for men and women Exclusion Criteria: * Patients with prior allogeneic transplant, or more than one prior autologous transplant for any medical reason * Prior treatment with busulfan or gemtuzumab (Mylotarg ®) for any reason * Patient with history of allergy to boron, mannitol, or bortezomib * Creatinine clearance (CrCl) =\< 50 ml/min * Ejection Fraction \< 50% * Diffusion capacity of carbon monoxide (DLCO) \< 50% predicted * Forced expiratory volume in 1 second (FEV1) \< 50% predicted * Forced vital capacity (FVC) \< 50% predicted * Patients with uncontrolled arrhythmia or uncontrolled heart disease at the screening time; patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months) need to be cleared with a stress echo or nuclear myocardial perfusion stress test, and cardiology consult; all other cardiac history will be at the discretion of the principal investigator * Liver enzymes \> 3 times upper limit normal * Bilirubin \> 2 mg/dl (except Gilbert's disease) * International normalized ratio (INR) \> 2 * Any previous history of liver failure, hepatitis, or cirrhosis * Systemic Amyloidosis Known history of hepatitis B, C, human immunodeficiency virus (HIV) or any current uncontrolled infection * Grade \> I neuropathy * Women who are pregnant or lactating * Current or history of alcohol or drug abuse * Use of other investigational agents within 30 days of enrollment to this study * Any patient with ascites * Any patient on home oxygen * Any clinical findings on history or physical exam which would in the opinion of the treating physician or principal investigator preclude the patient from participating in the study
References
Publications (0)
Data not yet available
No reference posted for this study.