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Stage II Multiple MyelomaPhase 2NCT00437034

Aflibercept for Relapsed Multiple Myeloma

A Phase 2 study testing aflibercept in people with Stage II Multiple Myeloma and Stage III Multiple Myeloma, run by National Cancer Institute (NCI) at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
6 sitesUnited States
Study dates
Jan 2007to Apr 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467-2490

Other trials in United States

About this study

Official title: A Phase 2 Study of Aflibercept for the Treatment of Relapsed or Refractory Multiple Myeloma

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.

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
aflibercept
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • afliberceptBiological

    Also called vascular endothelial growth factor trap, VEGF Trap, Zaltrap

    Given IV

Study groups in NCT00437034
Study groupRoleWhat they receive
Treatment (antiangiogenesis therapy)ExperimentalPatients 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.
Receives: Biological: aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline and every 4 weeks during study treatment until treatment discontinuation due to disease progression, unacceptable toxicities and/or patient withdrawal.

Secondary outcomes (7)

  1. Progression-free Survival (PFS)

    Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.

    Measured: Time from first treatment day until objective or symptomatic progression, assessed up to 6 months

  2. Overall Survival (OS)

    Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.

    Measured: Time from first treatment day until death, assessed up to 6 months

  3. Toxicities

    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.

    Measured: up to 6 months

  4. Tissue Expression Patterns of VEGFR Subtypes

    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.

    Measured: At baseline and post-treatment (1 week after 2nd dose and end of study)

  5. The Apoptotic State of Tumor Neovasculature

    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.

    Measured: At baseline and post-treatment (1 week after 2nd dose and end of study)

  6. Proangiogenic Factors Such as VEGF

    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.

    Measured: At baseline, before every course for 3 months, and then every 3 months during treatment for the first year

  7. Circulating Endothelial Progenitors

    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.

    Measured: At baseline, before every course for 3 months, and then every 3 months during treatment for the first year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionOct 2010
  4. Study completionApr 2011

Why it stopped: Poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00437034
Sponsor's protocol ID
NCI-2009-00181
Other IDs
NCI-2009-00181, 0608008688, 7521, P30CA013330, N01CM62204
Status last verified
Jan 2021
First submitted
15 Feb 2007
Last updated
8 Feb 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aflibercept in people with Stage II Multiple Myeloma and Stage III Multiple Myeloma, run by National Cancer Institute (NCI) at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00437034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.

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