Vorinostat in Combination With Bortezomib, Doxorubicin and Dexamethasone (VBDD) in Patients With Refractory or Relapsed Multiple Myeloma (MM) (VBDD)
Multiple Myeloma in Relapse
About this trial
This is an interventional treatment trial for Multiple Myeloma in Relapse focused on measuring Multiple Myeloma relapsed refractory
Eligibility Criteria
Inclusion Criteria:
- Patients with refractory or relapsed MM after at least first-line chemotherapy (CTx) or PBSCT (autologous and allogeneic SCT). All lines of relapse are eligible.
- KPS ≥60%
- Adequate BM function
- Adequate hepatic and renal function (AST and ALT ≤2.5 times ULN, Bilirubin ≤1.5 times ULN, eGFR >20 ml/min)
Exclusion Criteria:
- Patient has had prior treatment with Vorinostat or HDAC inhibitors
- Patients with severe hepatic impairment or acute diffuse infiltrative pulmonary and pericardial disease
- Patient has preexisting NCI CTC ≥grade 3 neuropathy
- Patient with known CNS MM-involvement and/or MM-related/induced meningitis
Sites / Locations
- University Medical Center Freiburg
Arms of the Study
Arm 1
Experimental
1
Vorinostat. To determine the MTD, dose escalation for Vorinostat will be conducted following the "3 + 3 design The first cohort of 3 patients will be given 100mg/d on days 1-4, 8-11, 15-18. The second cohort of 3 new patients will be treated with Vorinostat 200mg/d. The third cohort will be given Vorinostat 300mg/d. Cycles will be repeated every 28 days. Maximum treatment cycles: 6. Bortezomib will be administered intravenously (i.v.) 1.3mg/m2 BSA an days 1, 8, 15. Doxorubicin will be administered i.v. with a total dose of 18mg/m2 BSA per cycle (9mg/m2 BSA, d1 and 8). Dexamethasone will be administered per os (p.o.) with 40mg (first cycle) or 20mg (all other cycles) on d1, 8, 15, and 22.