Overview

Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
BB 1101
Busulfan
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Gemcitabine
Melphalan
Pyridoxal
Pyridoxine
Vitamin B 6
Vorinostat
Criteria
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 serum creatinine clearance >/=50 ml/min.

4. Adequate hepatic function, as defined by serum glutamate oxaloacetate (SGOT) and/or
serum glutamic-pyruvic transaminase (SGPT) bilirubin and alkaline phosphatase 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
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.