Phase 2 N=39 Treatment

Bevacizumab, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Stage II or III Multiple Myeloma

Multiple Myeloma in Relapse · Stage II Multiple Myeloma · Stage III Multiple Myeloma

Bottom Line

View on ClinicalTrials.gov: NCT00410605 ↗

Enrolled (actual)

Serious AEs

56.4%

Results posted

Sep 2017

Primary outcome: Primary: Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bevacizumab and Lenalidomide — 64 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bevacizumab (Biological); lenalidomide (Drug); dexamethasone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bevacizumab and Lenalidomide	64	—
PRIMARY Progression Free Survival (Time to Progression)	9	—
SECONDARY Toxicity and Tolerability of the Bevacizumab and Lenalidomide Combination	72	—
SECONDARY Effect of Bev/Rev on Markers of Myeloma Activity in Myeloma Cells and Stromal Cells at Baseline	17.2; 0.039; 0.084; 0.12; 8.85	—
SECONDARY Local Cytokine Milieu Using Tissue Micro Arrays of Bone Marrow Biopsy Specimens	—	—
SECONDARY Effect of Bev/Rev on Markers of Myeloma Activity in Myeloma Cells and Stromal Cells at 3 Months Post-baseline	5.5; 0.047; 0.054; 0.12; 8.17	—

Summary

This phase II trial is studying how well giving bevacizumab together with lenalidomide and dexamethasone works in treating patients with relapsed or refractory stage II or stage III multiple myeloma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Dexamethasone may stimulate the immune system in different ways and stop cancer cells from growing. Giving bevacizumab together with lenalidomide and dexamethasone may kill more cancer cells.

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed symptomatic multiple myeloma:
Stage II or III disease
Relapsed or refractory disease after >= 2 courses of prior chemotherapy
Measurable levels of monoclonal protein (M protein) > 1.0 g/dL by serum protein electrophoresis OR > 200 mg of monoclonal light chain by 24-hour urine protein electrophoresis
Measurable bone disease, defined as >= 1 unidimensionally measurable lesion (longest diameter to be recorded) >= 20 mm with conventional techniques OR >= 10 mm with spiral CT scan (for patients with lytic bone disease)
No known brain metastases
ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100%
Patients with PS of 3 are eligible if it is due to pain that is likely to improve with treatment
Life expectancy > 6 months
No known HIV positivity
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
No active infections requiring oral or intravenous antibiotics within the past week
No proteinuria (i.e., albuminuria) > 1,000 mg/24 hours unless related to the diagnosis of multiple myeloma
Patients with light chain (i.e., "Bence-Jones") proteinuria are still eligible if the non-light chain component of protein is 150/90 mm Hg (even with medication)
No significant traumatic injury within the past 28 days
No clinically significant peripheral vascular disease
No evidence of bleeding diathesis or coagulopathy
No unstable angina or myocardial infarction within the past 6 months
No stroke within the past 6 months
No New York Heart Association class III or IV heart failure
No secondary malignancy within the past 2 years except squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix
Hemoglobin > 9 g/dL (may be supported by transfusion or growth factors)
WBC >= 2,000/mm^3
Absolute neutrophil count >= 1,000/mm^3
Platelet count >= 75,000/mm^3
Bilirubin = 75,000/mm3
INR 2-3 and stable
No concurrent major surgery
No concurrent sargramostim (GM-CSF)
No other concurrent investigational agents
No other concurrent anticancer agents or therapies
AST and ALT =< 5 times upper limit of normal
Creatinine < 2.5 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and 4 weeks after completion of study treatment
No history of allergic reactions attributed to compounds of similar chemical or biological composition to lenalidomide and/or bevacizumab or other agents used in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00410605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.