NCT00437034 · REGISTRY CONDITION SEARCH

Aflibercept for Relapsed Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2021-02-08

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response Rate (Complete [CR] and Partial Response [PR])

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Toxicities

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outcome · POSTED

Tissue Expression Patterns of VEGFR Subtypes

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outcome · POSTED

The Apoptotic State of Tumor Neovasculature

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outcome · POSTED

Proangiogenic Factors Such as VEGF

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outcome · POSTED

Circulating Endothelial Progenitors

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Biological: aflibercept
label
Treatment (antiangiogenesis therapy)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (antiangiogenesis therapy)
description
Given IV
name
aflibercept
other Names
vascular endothelial growth factor trap
VEGF Trap
Zaltrap
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 6
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Overall Response Rate (Complete [CR] and Partial Response [PR])
time Frame
At baseline and every 4 weeks during study treatment until treatment discontinuation due to disease progression, unacceptable toxicities and/or patient withdrawal.

secondary Outcomes

description
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
measure
Progression-free Survival (PFS)
time Frame
Time from first treatment day until objective or symptomatic progression, assessed up to 6 months
description
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
measure
Overall Survival (OS)
time Frame
Time from first treatment day until death, assessed up to 6 months
description
Toxicities will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 terminology. Exact 95% confidence intervals around the toxicity proportions will be calculated to assess the precision of the obtained estimates.
measure
Toxicities
time Frame
up to 6 months
description
The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar's test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.
measure
Tissue Expression Patterns of VEGFR Subtypes
time Frame
At baseline and post-treatment (1 week after 2nd dose and end of study)
description
The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar's test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.
measure
The Apoptotic State of Tumor Neovasculature
time Frame
At baseline and post-treatment (1 week after 2nd dose and end of study)
description
The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar's test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.
measure
Proangiogenic Factors Such as VEGF
time Frame
At baseline, before every course for 3 months, and then every 3 months during treatment for the first year
description
The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar's test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.
measure
Circulating Endothelial Progenitors
time Frame
At baseline, before every course for 3 months, and then every 3 months during treatment for the first year

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

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source file
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source url
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Preserved source evidence · Not medical advice