A Phase 2 interventional study of aflibercept in Stage II Multiple Myeloma and Stage III Multiple Myeloma, sponsored by National Cancer Institute (NCI). Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 6 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Histologically or cytologically confirmed multiple myeloma
Measurable disease, defined by ≥ 1 of the following criteria:
Must have received ≥ 2 prior therapies* for multiple myeloma that meet the following criteria:
No albuminuria only
Exclusion criteria:
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.
Biological: aflibercept
Given IV
Also known as: vascular endothelial growth factor trap, VEGF Trap, Zaltrap
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.
Time frame: 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)
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Time frame: Time from first treatment day until objective or symptomatic progression, assessed up to 6 months
Overall Survival (OS)
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Time frame: Time from first treatment day until death, assessed up to 6 months
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.
Time frame: up to 6 months
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.
Time frame: At baseline and post-treatment (1 week after 2nd dose and end of study)
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.
Time frame: At baseline and post-treatment (1 week after 2nd dose and end of study)
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.
Time frame: At baseline, before every course for 3 months, and then every 3 months during treatment for the first year
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.
Time frame: At baseline, before every course for 3 months, and then every 3 months during treatment for the first year
A total of 6 patients were enrolled at two institutions between January 2007 and April 2010
| Milestone | Treatment (Antiangiogenesis Therapy) |
|---|---|
| Started | 6 |
| Completed | 0 |
| Not completed | 6 |
| Withdrew: Adverse event | 1 |
| Withdrew: Disease progression during treatment | 5 |
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.
| participants | Treatment (Antiangiogenesis Therapy) |
|---|---|
| Disease progression | 5 |
| Stable disease | 1 |
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
No measurements were reported for this outcome.
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
No measurements were reported for this outcome.
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.
| Participants | Treatment (Antiangiogenesis Therapy) |
|---|---|
| Toxicities | 6 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Antiangiogenesis Therapy) | — | 0/6 (0%) | 6/6 (100%) |
| Event | Treatment (Antiangiogenesis Therapy) |
|---|---|
| HypertensionVascular disorders | 6/6 |
| AnemiaBlood and lymphatic system disorders | 4/6 |
| FatigueGeneral disorders | 3/6 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/6 |
| Voice changesRespiratory, thoracic and mediastinal disorders | 2/6 |
| Neutrophil count decreasedInvestigations | 2/6 |
| HeadacheNervous system disorders | 2/6 |
| InsomniaPsychiatric disorders | 1/6 |
| DizzinessNervous system disorders | 1/6 |
| ODYNOPHAGIA (PAINFUL SWALLOWING)Gastrointestinal disorders | 1/6 |
| Age, Continuous(years) | Treatment (Antiangiogenesis Therapy) |
|---|---|
| Median | 59 (37 to 68) |
| Sex: Female, Male(Participants) | Treatment (Antiangiogenesis Therapy) |
|---|---|
| Female | 1 |
| Male | 5 |
| Race/Ethnicity, Customized(participants) | Treatment (Antiangiogenesis Therapy) |
|---|---|
| White | 4 |
| African American | 1 |
| Unknown | 1 |
This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Cancer Institute (NCI)