Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase II, randomized, blinded, placebo-controlled, multicenter study designed to provide a preliminary assessment of the safety and efficacy of combining bevacizumab with bortezomib in patients with relapsed or refractory multiple myeloma starting 11 July 2007 and completing 9 November 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
BORT + P	Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
BORT + BV	Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.

Participant Flow:   Overall Study

	BORT + P	BORT + BV
STARTED	53	49
Treated	52	48
Safety Population	50 [1]	50
COMPLETED	8 [2]	11 [2]
NOT COMPLETED	45	38
Adverse Event	3	3
Death	4	2
Progression not resulting in death	24	20
Non–protocol-specified therapy	7	5
Physician Decision	2	4
Withdrawal by Subject	5	3
Unknown	0	1

Reporting Groups

	Description
BORT + P	Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
BORT + BV	Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.

Baseline Measures

	BORT + P	BORT + BV	Total
Number of Participants   [units: participants]	53	49	102
Age   [units: years] Mean ± Standard Deviation	64.9  ± 9.2	65.6  ± 9.3	65.2  ± 9.2
Gender   [units: participants]
Female	23	20	43
Male	30	29	59

1.  Primary:

Progression-free Survival (PFS)   [ Time Frame: From randomization to disease progression or death on study (up to 116 weeks). ]

2.  Secondary:

Number of Participants With an Overall Response   [ Time Frame: From randomization to the end of study (clinical cut-off; up to 116 weeks). ]

3.  Secondary:

Percentage of Participants With an Overall Response   [ Time Frame: From randomization to the end of study (clinical cut-off; up to 116 weeks). ]

4.  Secondary:

Duration of Response   [ Time Frame: From randomization to the end of study (clinical cut-off; up to 116 weeks). ]

5.  Secondary:

Overall Survival (OS)   [ Time Frame: From randomization until death from any cause, up until the end of study (clinical cut-off; up to 116 weeks). ]

6.  Secondary:

Number of Participants With Selected Adverse Events (AEs)   [ Time Frame: Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination (up to 122 weeks). ]