Aflibercept for Relapsed Multiple Myeloma

NCT ID: NCT00437034

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-04-30

Brief Summary

This phase II trial is studying the side effects and how well aflibercept works in treating patients with stage II or stage III multiple myeloma that has relapsed or not responded to previous treatment. Aflibercept may be able to carry cancer-killing substances directly to multiple myeloma cells. It may also stop the growth of multiple myeloma by blocking blood flow to the cancer.

Detailed Description

OBJECTIVES:

I. To evaluate the safety and efficacy of VEGF Trap (aflibercept) in patients with relapsed or refractory, stage II or III multiple myeloma (MM).

II. To perform correlative studies in order to evaluate the angiogenic properties of tissue from patients during the course of treatment with VEGF Trap.

OUTLINE: This is a multicenter study.

Patients receive aflibercept intravenously (IV) over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 60 days and then periodically thereafter.

Conditions

Stage II Multiple Myeloma; Stage III Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (antiangiogenesis therapy)

Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

aflibercept

Intervention Type: BIOLOGICAL

Given IV

Interventions

aflibercept

Given IV

Intervention Type: BIOLOGICAL

Other Intervention Names

vascular endothelial growth factor trap; VEGF Trap; Zaltrap

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed multiple myeloma

• Stage II or III disease according to Salmon-Durie staging criteria
• Relapsed or refractory disease
• Progressive disease
• Measurable disease, defined by ≥ 1 of the following criteria:

• Serum M protein ≥ 1.0 g/dL by serum protein electrophoresis
• Free light chain measurement > 200 mg/dL
• Urinary M protein excretion ≥ 200 mg/24 hours
• Must have received ≥ 2 prior therapies* for multiple myeloma that meet the following criteria:

• Antimyeloma therapeutic regimen consisting of ≥ 1 complete course of single-agent or combination-agent therapy, or a planned series of treatments (e.g., 3-4 courses of induction therapy followed by a stem cell harvest procedure followed by conditioning high-dose therapy supported by stem cell transplantation)
• Antimyeloma regimen is discontinued because of the development of resistant disease or severe therapy-related toxicity
• Individual antimyeloma regimen will be considered to have been discontinued when all agents of the regimen have been permanently stopped
• A prior regimen will not be considered to have been discontinued for the modification of drug doses, or if less than all the agents of a combination regimen have been discontinued, or if the regimen has been halted temporarily for the development of a plateau phase of myeloma
• Maintenance therapy will not be considered an additional regimen
• If new agents are added to an existing regimen, presumably because of tumor resistance, the old regimen will be considered to have ended and a new regimen to have started
• No evidence of central nervous system (CNS) disease, including primary brain tumor or brain metastasis
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy > 12 weeks
• White blood cell (WBC) ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 75,000/mm^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN
• Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
• No albuminuria only

• Urine protein: creatinine ratio < 1 OR 24-hour urine protein with an albumin level < 500 mg
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy

Exclusion Criteria

• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No known history of allergic reactions attributed to compounds of similar chemical or biological composition to other agents used in the study
• No serious or nonhealing wound, ulcer, or bone fracture
• No significant traumatic injury within the past 28 days
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• No clinically significant cardiovascular disease
• No prothrombin time (PT) or international normalized ratio (INR) > 1.5 (unless patient is on full-dose warfarin)
• No evidence of bleeding diathesis or coagulopathy
• No uncontrolled intercurrent illness that would limit compliance with study requirements, including ongoing or active infection
• No psychiatric illness or social situations that would limit study compliance
• No concurrent major surgery
• No concurrent immunosuppressive agents (including steroids)
• No other concurrent investigational agents

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruben Niesvizky-Iszaevich

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

North Shore University Hospital

Manhasset, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Weill Medical College of Cornell University

New York, New York, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

NCI-2009-00181

Identifier Type: REGISTRY

Identifier Source: secondary_id

0608008688

Identifier Type: OTHER

Identifier Source: secondary_id

7521

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA013330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62204

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00181

Identifier Type: -

Identifier Source: org_study_id