Myeloma Clinical Trial
Official title:
Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Myeloma
NCT number | NCT02114502 |
Other study ID # | 2013-0892 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | April 11, 2014 |
Last updated | July 9, 2014 |
Start date | September 2014 |
Verified date | July 2014 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Remission (CR) Rate | Complete remission (CR) rate defined as percentage of number of complete responses in total number of patients treated. | 100 days | Yes |
Secondary | Response Rates (RR) | Response rates (CR; CR/VGPR; RR) reported along with corresponding 95% confidence intervals. Logistic regression used to model the association between response rates and prognostic factors. Overall survival (OS) and progression free survival (PFS) estimated by the Kaplan-Meier method. Comparison of time to event endpoints by subgroups made using the log-rank test. Cox proportional hazards regression employed for univariate and multivariate analysis on time-to-event outcomes. | 100 days | Yes |
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