Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma
1 other identifier
interventional
N/A
0 countries
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Brief Summary
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedJuly 11, 2014
July 1, 2014
4 years
April 11, 2014
July 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Remission (CR) Rate
Complete remission (CR) rate defined as percentage of number of complete responses in total number of patients treated.
100 days
Secondary Outcomes (1)
Response Rates (RR)
100 days
Study Arms (1)
Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT
EXPERIMENTALBusulfan 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.
Interventions
27 mg/m2 by vein on Days -7 and -6, then on Days -2 and -1
1,000 mg by mouth on Days -8 to -3.
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.
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.
60 mg/m2 by vein on Days -3 and -2.
Stem cell transplant on Day 0.
60 microgram/kg by vein on Days -12 to -10 and Days 0, +1 and +2.
8 mg by vein twice a day from Day -9 PM to Day -2 PM.
30 mL oral rinse four times a day from Day -9 until discharge.
15 g four times a day, swished, gargled and spit on Day -9 until discharge.
100 mg by vein or mouth three times a day from Day -1.
Eligibility Criteria
You may qualify if:
- Age 18 to 65 years
- 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.
- Adequate renal function, as defined by serum creatinine \</=1.8 mg/dL and/or estimated serum creatinine clearance \>/=50 ml/min.
- 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.
- Adequate pulmonary function with FEV1, FVC and DLCO \>/=50% of expected corrected for hemoglobin and/or volume.
- Adequate cardiac function with left ventricular ejection fraction \>/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance status \<2.
- Negative Beta HCG text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
You may not qualify if:
- Patients with grade \>/= 3 non-hematologic toxicity from previous therapy that has not resolved to \</= grade 1.
- Prior whole brain irradiation.
- Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA \>/=10,000 copies/mL, or \>/= 2,000 IU/mL).
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- Active infection requiring parenteral antibiotics.
- HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts.
- 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.
- Autologous stem-cell transplant in the previous six months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yago Nieto, MD,PHD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2014
First Posted
April 15, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2018
Last Updated
July 11, 2014
Record last verified: 2014-07