NCT00437034|TerminatedPhase 2ResultsDMC
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Poor accrual
A Phase 2 Study of Aflibercept for the Treatment of Relapsed or Refractory Multiple Myeloma
Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
OTHER · Montefiore Medical Center
OTHER · CTEP/NCI
NIH
NIH
interventional
6
1 country
6
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2010
Actual (reported)Study Completion
April 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
February 15, 2007
Actual (reported)February 19, 2007
Actual (reported)October 2010
Actual (reported)April 2011
Actual (reported)July 29, 2015
Actual (reported)Overall Response Rate (Complete [CR] and Partial Response [PR])
A 95% confidence interval was intended to be estimated via binomial proportions, but was not computed due to small sample size. Criteria for Response from EBMT, IBMTR, ABMTR: Complete Response:Complete absence of monoclonal protein by immunofixation for a minimum of 6 weeks; Near Complete Response:Absence of serum paraprotein by standard serum/urine protein electrophoresis without disappearance of monoclonal spike by immunofixation; Partial Response:Sustained decrease in production rate of monoclonal serum protein to 50% or less of pretreatment value; Stable Disease: No significant change from baseline; Progression of Disease:Patients with a \> or = 25% rise in production rate, new/increased size of lytic lesions/plasmacytomas/progressive marrow plasmacytosis; Symptomatic Deterioration:Patients with deterioration of health requiring discontinuation of treatment w/out objective evidence of disease progression.
At baseline and every 4 weeks during study treatment until treatment discontinuation due to disease progression, unacceptable toxicities and/or patient withdrawal.
Progression-free Survival (PFS)
Time from first treatment day until objective or symptomatic progression, assessed up to 6 months
Overall Survival (OS)
Time from first treatment day until death, assessed up to 6 months
Toxicities
up to 6 months
Tissue Expression Patterns of VEGFR Subtypes
At baseline and post-treatment (1 week after 2nd dose and end of study)
The Apoptotic State of Tumor Neovasculature
At baseline and post-treatment (1 week after 2nd dose and end of study)
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.
Given IV
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
North Shore University Hospital
Manhasset, New York, 11030, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Weill Medical College of Cornell University
New York, New York, 10065, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
Ruben Niesvizky-Iszaevich
Montefiore Medical Center
6 participants (actual enrollment reported by the registry).
First Submitted
February 15, 2007
First Posted
February 19, 2007
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Adjuvant Aflibercept for Metastatic Colorectal Cancer
Contact the study team to confirm eligibility.
Primary Completion
October 2010
Actual (reported)Study Completion
April 2011
Actual (reported)Last Updated
February 8, 2021
Results First Posted
July 29, 2015
Record last verified: 2021-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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