Clinical trial · Interventional
Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma
Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Myeloma
NCT02114502CI-TRIAL-00015054withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this clinical research study is to learn if carfilzomib and vorinostat combined with gemcitabine, busulfan, and melphalan with a stem cell transplant will help to control multiple myeloma (MM). Researchers also want to learn about the safety and effectiveness of this combination.
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 |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Caphosol | Drug | — | UNRESOLVED |
| Carfilzomib | Drug | Carfilzomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Glutamine | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Palifermin | Drug | — | UNRESOLVED |
| Pyridoxine | Drug | — |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT
- description
- Busulfan test dose of 32 mg/m2 by vein on Day -10 if inpatient, on Day -12 if outpatient, then AUC of 4,000 microMol.min on Days -8 to -5. Palifermin 60 microgram/kg by vein on Days -12 to -10 and Days 0, +1 and +2. SAHA 1,000 mg by mouth on Days -8 to -3. Gemcitabine loading dose of 75 mg/m2 followed by continuous infusion of the remaining dose of 1875 mg/m2 by vein on Days -8 and -3. Carfilzomib 27 mg/m2 by vein on Days -7 and -6, then on Days -2 and -1. SAHA 1,000 mg by mouth on Days -7 to -3. Melphalan 60 mg/m2 by vein on Days -3 and -2. Stem cell transplant on Day 0. Dexamethasone 8 mg by vein twice a day from Day -9 PM to Day -2 PM. Caphosol oral rinses 30 mL four times a day from Day -9 until discharge. Oral glutamine 15 g four times a day, swished, gargled and spit on Day -9 until discharge. Pyridoxine 100 mg by vein or mouth three times a day from Day -1.
- interventionNames
- Drug: Carfilzomib
- Drug: SAHA
- Drug: Gemcitabine
- Drug: Busulfan
- Drug: Melphalan
- Procedure: Stem Cell Transplant (SCT)
- Drug: Palifermin
- Drug: Dexamethasone
- Drug: Caphosol
- Drug: Glutamine
- Drug: Pyridoxine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 to 65 years 2. Refractory or relapsed myeloma, defined as one or more of the following: 1. Patients with myeloma treated with first-line therapy including lenalidomide, bortezomib or thalidomide, and one or more of the following: a. Less than partial response to first-line therapy. b. Relapse after 1st line therapy. 2. High-risk disease, defined by del(13q) by conventional cytogenetics, or by del(17p), t(4;14), t(14;16), t(14;20) or 1q+ by FISH. 3. Relapse after a prior autologous stem-cell transplantation (ASCT). 4. Plasma cell leukemia. 5. Plasmablastic lymphoma. 6. Soft tissue plasmacytoma. 3. Adequate renal function, as defined by serum creatinine \</=1.8 mg/dL and/or estimated serum creatinine clearance \>/=50 ml/min. 4. Adequate hepatic function, as defined by serum glutamate oxaloacetate (SGOT) and/or serum glutamic-pyruvic transaminase (SGPT) \</=3 x upper limit of normal; serum bilirubin and alkaline phosphatase \</=2 x upper limit of normal, unless proven to be due to disease involvement. 5. Adequate pulmonary function with FEV1, FVC and DLCO \>/=50% of expected corrected for hemoglobin and/or volume. 6. Adequate cardiac function with left ventricular ejection fraction \>/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease. 7. Zubrod performance status \<2. 8. Negative Beta HCG text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Exclusion Criteria: 1. Patients with grade \>/= 3 non-hematologic toxicity from previous therapy that has not resolved to \</= grade 1. 2. Prior whole brain irradiation. 3. Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA \>/=10,000 copies/mL, or \>/= 2,000 IU/mL). 4. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology. 5. Active infection requiring parenteral antibiotics. 6. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts. 7. Patients having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment. 8. Autologous stem-cell transplant in the previous six months.
References
Publications (0)
Data not yet available
No reference posted for this study.