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Status:

TERMINATED

Aflibercept for Relapsed Multiple Myeloma

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Stage II Multiple Myeloma

Stage III Multiple Myeloma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 treatmen...

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 or...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2011

    Estimated Enrollment :

    6 Patients enrolled

    Trial Details

    Trial ID

    NCT00437034

    Start Date

    January 1 2007

    End Date

    April 1 2011

    Last Update

    February 8 2021

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    North Shore University Hospital

    Manhasset, New York, United States, 11030

    2

    Mount Sinai Medical Center

    New York, New York, United States, 10029

    3

    Columbia University Medical Center

    New York, New York, United States, 10032

    4

    Weill Medical College of Cornell University

    New York, New York, United States, 10065