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Trial Outcomes & Findings for Aflibercept for Relapsed Multiple Myeloma (NCT NCT00437034)

NCT ID: NCT00437034

Last Updated: 2021-02-08

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

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

Results posted on

2021-02-08

Participant Flow

A total of 6 patients were enrolled at two institutions between January 2007 and April 2010

Participant milestones

Participant milestones
Measure
Treatment (Antiangiogenesis Therapy)
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. aflibercept: Given IV
Overall Study
STARTED
6
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Treatment (Antiangiogenesis Therapy)
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. aflibercept: Given IV
Overall Study
Adverse Event
1
Overall Study
Disease progression during treatment
5

Baseline Characteristics

Aflibercept for Relapsed Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment (Antiangiogenesis Therapy)
n=6 Participants
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. aflibercept: Given IV
Age, Continuous
59 years
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
Race/Ethnicity, Customized
White
4 participants
n=5 Participants
Race/Ethnicity, Customized
African American
1 participants
n=5 Participants
Race/Ethnicity, Customized
Unknown
1 participants
n=5 Participants

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Treatment (Antiangiogenesis Therapy)
n=6 Participants
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. aflibercept: Given IV
Overall Response Rate (Complete [CR] and Partial Response [PR])
Disease progression
5 participants
Overall Response Rate (Complete [CR] and Partial Response [PR])
Stable disease
1 participants

SECONDARY outcome

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

Population: Data not collected

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Overall survival was not assessed by the Kaplan-Meier survival or calculated using the Greenwood's formulae.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months

Population: Participants with grade 1 and 2 adverse events

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.

Outcome measures

Outcome measures
Measure
Treatment (Antiangiogenesis Therapy)
n=6 Participants
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. aflibercept: Given IV
Toxicities
6 Participants

SECONDARY outcome

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

Population: data not collected

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: data not collected

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: data not collected

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: data not collected

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.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Antiangiogenesis Therapy)

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Treatment (Antiangiogenesis Therapy)
n=6 participants at risk
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. aflibercept: Given IV
Respiratory, thoracic and mediastinal disorders
Cough
33.3%
2/6 • Number of events 2
Vascular disorders
Hypertension
100.0%
6/6 • Number of events 6
Psychiatric disorders
Insomnia
16.7%
1/6 • Number of events 1
Blood and lymphatic system disorders
Anemia
66.7%
4/6 • Number of events 4
Nervous system disorders
Dizziness
16.7%
1/6 • Number of events 1
Gastrointestinal disorders
ODYNOPHAGIA (PAINFUL SWALLOWING)
16.7%
1/6 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Voice changes
33.3%
2/6 • Number of events 2
Skin and subcutaneous tissue disorders
Rash: desquamation
16.7%
1/6 • Number of events 1
Musculoskeletal and connective tissue disorders
Pain: Muscle
16.7%
1/6 • Number of events 1
General disorders
Fatigue
50.0%
3/6 • Number of events 3
Gastrointestinal disorders
Diarrhea
16.7%
1/6 • Number of events 1
Investigations
Leukocytes decreased
16.7%
1/6 • Number of events 1
Gastrointestinal disorders
Anorexia
16.7%
1/6 • Number of events 1
Nervous system disorders
Ataxia
16.7%
1/6 • Number of events 1
Investigations
Alkaline phosphatase increased
16.7%
1/6 • Number of events 1
Investigations
Neutrophil count decreased
33.3%
2/6 • Number of events 2
Investigations
Platelet count decreased
16.7%
1/6 • Number of events 1
Investigations
Creatinine increased
16.7%
1/6 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Dyspnea
16.7%
1/6 • Number of events 1
Nervous system disorders
Headache
33.3%
2/6 • Number of events 2
Metabolism and nutrition disorders
Hypocalcemia
16.7%
1/6 • Number of events 1
Musculoskeletal and connective tissue disorders
Muscle weakness
16.7%
1/6 • Number of events 1
Psychiatric disorders
Depression
16.7%
1/6 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
16.7%
1/6 • Number of events 1

Additional Information

Lisa Escobar-Peralta, Program Manager

Montefiore Medical Center

Phone: 718-379-6866

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60