Vorinostat in Combination With Bortezomib, Doxorubicin and Dexamethasone (VBDD) in Patients With Refractory or Relapsed Multiple Myeloma (MM)

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective of the study is the determination of the maximum tolerated dose (MTD) of Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and Dexamethasone (D).

Secondary objectives are:

Assessment of safety and tolerability of VBDD; efficacy data of VBDD.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Freiburg
• Collaborators: Janssen-Cilag Ltd.; Merck Sharp & Dohme Corp.
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Vorinostat

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