Conditions: Multiple Myeloma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 38
Healthy volunteers: no

Brief summary:
PRIMARY STUDY OBJECTIVES

* To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients:

  1. Patients post first line therapy
  2. Patients with relapsed/refractory disease who are bortezomib-naïve
* To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma.

SECONDARY STUDY OBJECTIVES

* To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect \> 10 x 106 CD34+ cells/kg in \< 7 collections (for both subsets of multiple myeloma patients).
* To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients).

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Bortezomib intervention 2: dexamethasone intervention 3: liposomal doxorubicin intervention 4: cyclophoshamide intervention 5: filgrastim
Intervention descriptions: intervention 1: During Induction Phase (6 cycles): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 During 21-day mobilization cycle (1 cycle): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 intervention 2: During Induction Phase (6 cycles): dexamethasone 40 mg on days 1-4, 8-11, and 15-18 intervention 3: If patients achieve less then a PR during the induction phase after 2 cycles, or less then a CR after 4 cycles: Liposomal doxorubicin was added at 30 mg/m2 on day 4 for the remaining cycles intervention 4: During the 21 day mobilization phase (1 cycle): cyclophosphamide at 3 g/m2 on day 8 intervention 5: During the 21 day mobilization phase (1 cycle): 10 μg/kg/day for 10 consecutive days starting 24 hours after cyclophosphamide administration on day 9

Protocol document: