8
Participants
Start Date
June 22, 2016
Primary Completion Date
April 8, 2019
Study Completion Date
April 8, 2019
Lenalidomide
"Dose Escalation Phase Starting dose of Lenalidomide: 50 mg by mouth on Days -9 to -2.~Dose Expansion Phase Starting Dose: Maximum tolerated dose from Phase I."
Vorinostat
1000 mg by mouth on Days -9 to -2.
Gemcitabine
Gemcitabine administered as a loading dose of 75 mg/m2 by vein on Day -8 and 2775 mg by vein on Day -3.
Busulfan
"Busulfan test dose administered by vein either as outpatient before admission, or as inpatient on day -10. The test dose of 32 mg/m2 based on actual body weight. Doses of days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1."
Melphalan
60 mg/m2 by vein on days -3 and -2.
Rituximab
Patients with CD20+ tumors receive Rituximab 375 mg/m2 by vein on day -9 in the AM as an inpatient.
Dexamethasone
8 mg by vein twice a day from Day -8 AM to Day -2 PM.
Caphosol
Caphosol oral rinses 30 mL four times a day used from Day -8.
Glutamine
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine
100 mg by vein or mouth three times a day from Day -1
Enoxaparin
40 mg subcutaneously daily from admission until platelet count drops below 50,000/mm3.
Stem Cell Transplant
Stem cell transplant performed on Day 0.
Palifermin
Palifermin per departmental standard of care with 3 doses to be administered prior to starting chemotherapy and 3 doses starting on day 0.
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
Celgene Corporation
INDUSTRY
M.D. Anderson Cancer Center
OTHER