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A Randomized, Blinded, Placebo-Controlled, Multicenter, Phase II Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Randomized, Blinded, Placebo-Controlled, Multicenter, Phase II Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

Progression-free survival (PFS) was defined as the time from randomization to disease progression or death on study from any cause within 30 days of the last response assessment. Disease progression was determined by the investigator using the International Myeloma Working Group's (IMWG) uniform response criteria. Median PFS was estimated using Kaplan-Meier methodology. For patients who were alive at the time of the analysis and whose disease had not yet progressed, PFS was censored at the time of the last response assessment.

Outcome Time Frame:

From randomization to disease progression or death on study (up to 116 weeks).

Safety Issue:

No

Principal Investigator

Virginia (Ginny) Paton, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

AVF4064g

NCT ID:

NCT00473590

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Avastin
  • AMBER
  • Myeloma
  • Velcade
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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