Clinical trial NCT00473590: A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER)
Official title: A Randomized, Blinded, Placebo-Controlled, Multicenter, Phase II Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Avastin
AMBER
Myeloma
Velcade
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2007-05-15
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, blinded, placebo-controlled, multicenter, Phase II 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Previously diagnosed with multiple myeloma
* Relapsed or refractory multiple myeloma with disease progression following one to three prior treatment regimens
* Measurable multiple myeloma disease

Exclusion Criteria:

* Grade ≥ 2 peripheral neuropathy
* Use of corticosteroids within 21 days prior to Day 1
* Use of other anti-myeloma therapy within 21 days prior to Day 1
* Intolerance to bortezomib or compounds containing boron
* Life expectancy of \< 12 weeks
* Current, recent, or planned participation in an experimental drug study
* Active malignancy other than multiple myeloma within 5 years before screening
* Prior treatment with bevacizumab
* Inadequately controlled hypertension
* Prior history of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF)
* Decreased left ventricular function at study entry
* History of myocardial infarction or unstable angina within 6 months prior to Day 1
* History of stroke or transient ischemic attack within 6 months prior to Day 1
* Significant vascular disease or recent peripheral arterial thrombosis within 6 months prior to Day 1
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
* Core biopsy or other minor surgical procedure, including placement of a vascular access device within 7 days prior to Day 1
* History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
* Serious, non-healing wound, active ulcer, or untreated bone fracture (for pathologic bone fractures consistent with multiple myeloma, patients may be eligible if no treatment is planned)
* Albuminuria
* Known hypersensitivity to any component of bevacizumab
* Pregnancy (positive pregnancy test) or lactation

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From randomization to disease progression or death on study (up to 116 weeks).
Secondary outcomes:
measure: Number of Participants With an Overall Response
timeFrame: From randomization to the end of study (clinical cut-off; up to 116 weeks).
measure: Percentage of Participants With an Overall Response
timeFrame: From randomization to the end of study (clinical cut-off; up to 116 weeks).
measure: Duration of Response
timeFrame: From randomization to the end of study (clinical cut-off; up to 116 weeks).
measure: Overall Survival (OS)
timeFrame: From randomization until death from any cause, up until the end of study (clinical cut-off; up to 116 weeks).
measure: Number of Participants With Selected Adverse Events (AEs)
timeFrame: Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination (up to 122 weeks).
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Virginia (Ginny) Paton, M.D.
role: STUDY_DIRECTOR
References: