Clinical trial · Interventional
Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase II Trial of Bevacizumab in Patients With Relapsed or Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: 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 may also stop the growth of multiple myeloma by blocking blood flow to the cancer. PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with relapsed or refractory multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Confirmed hematologic response
- measure
- Progression-free survival at 1 year
Secondary outcomes (4)
- measure
- Toxicity as measured by NCI CTCAE v3.0
- measure
- Time to progression
- measure
- Duration of response
- measure
- Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of relapsed or refractory multiple myeloma * Measurable or evaluable disease as defined by ≥ 1 of the following: * Serum monoclonal protein ≥ 1.0 g by protein electrophoresis * Monoclonal protein ≥ 200 mg by 24-hour urine electrophoresis * Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio * Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease) * No concurrent amyloidosis PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0 or 1 * ECOG PS 2 based on immobility from myeloma bone disease alone allowed at the discretion of treating physician * Creatinine ≤ 2.0 mg/dL * ANC ≥ 1,000/mm³ * Platelet count ≥ 75,000/mm³ * Hemoglobin ≥ 8.0 g/dL * Proteinuria ≤ 1 g/dL by 24-hour urine collection (excluding monoclonal protein) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment * No bleeding diathesis * No hypertension (defined as BP \> 150/100 mm Hg) * No active bleeding, healing or nonhealing wound, ulcer, or bone fracture (excluding fractures secondary to myeloma) * No active ulcerative disease including, but not limited to, any of the following: * Peptic ulcer disease * Ulcerative esophagitis * Ulcerative colitis * Crohn's disease * LVEF ≥ 50% by 2-dimensional ECHO or MUGA scan * No NYHA class III or IV heart disease * No other active malignancy except for nonmelanoma skin cancer or in situ cervical or breast cancer * No active infection * No other comorbidity that would interfere with study compliance * No transient ischemic attack, cerebrovascular accident, or myocardial infarction within the past year * No abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the past 6 months * No significant traumatic injury within the past 28 days PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 2 prior antimyeloma treatment courses, except for bisphosphonates * No standard or experimental drug therapy, other than ongoing bisphosphonate treatment and/or epoetin alfa, within the past 28 days * No experimental non-drug therapy within the past 28 days * Palliative radiation therapy within the past 28 days allowed provided ≤ 3 sites of bone disease was irradiated * No prior bevacizumab or other experimental antiangiogenic agents other than thalidomide or lenalidomide * No minor surgical procedures, fine-needle aspiration, or core biopsies within the past 7 days * No major surgical procedure or open biopsy within the past 28 days * No concurrent corticosteroids * Chronic steroids ≤ 20 mg/day (prednisone equivalent) for disorders other than myeloma (i.e., adrenal insufficiency, rheumatoid arthritis) allowed * No other concurrent investigational therapy * No other concurrent systemic antineoplastic therapy including, but not limited to, the following: * Cytotoxic chemotherapy * Immunotherapy * Hormonal therapy * Monoclonal antibody therapy * Concurrent bisphosphonates allowed
References
Publications (0)
Data not yet available