Trial Outcomes & Findings for Lenalidomide and Nivolumab in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT03333746)
NCT ID: NCT03333746
Last Updated: 2019-05-30
Results Overview
Will be assessed by IMWG response criteria. 95% binomial confidence intervals will also be calculated for the estimate of the proportion of responses.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2019-05-30
Participant Flow
Participant milestones
| Measure |
Treatment (Lenalidomide, Nivolumab)
Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
Nivolumab: Given IV
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide and Nivolumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment (Lenalidomide, Nivolumab)
n=1 Participants
Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
Nivolumab: Given IV
Pharmacological Study: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: data was not collected and analyzed
Will be assessed by IMWG response criteria. 95% binomial confidence intervals will also be calculated for the estimate of the proportion of responses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: data was not collected and analyzed
Will evaluate other clinical outcomes using the methods of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from study entry until disease progression or death at trial closure for the per protocol population, assessed up to 3 yearsPopulation: data was not collected and analyzed
Will evaluate other clinical outcomes using the methods of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from start of treatment until the date he or she has progression or dies, assessed up to 3 yearsPopulation: data was not collected and analyzed
Will be assessed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPopulation: data not collected and analyzed
Will be explored using graphical analyses as well as summarized quantitatively.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPopulation: data not collected and analyzed
Will be explored using graphical analyses as well as summarized quantitatively.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, days 1 and 14 of each cyclePopulation: data not collected and analyzed
Will be assessed using Cmax for Nivolumab in combination with lenalidomide
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, days 1 and 14 of each cyclePopulation: data not collected and analyzed
Will be assessed using Tmax for Nivolumab in combination with lenalidomide
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Lenalidomide, Nivolumab)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Lenalidomide, Nivolumab)
n=1 participants at risk
Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
Nivolumab: Given IV
Pharmacological Study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 6 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Investigations
Aspartate Aminotransferasae Increased
|
100.0%
1/1 • Number of events 2 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Investigations
Blood Bilirubin Increased
|
100.0%
1/1 • Number of events 2 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Nervous system disorders
Cognitive Disturbance
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough (non-productive)
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Gastrointestinal disorders
Diarrhea-intermittent
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Dry Skin- Bilateral Lower Extremities
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Eye disorders
Eye Hemorrhage
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 4 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Generlized Weakness
|
100.0%
1/1 • Number of events 3 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
General disorders
Hip Pain- Bilateral
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
100.0%
1/1 • Number of events 2 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • Number of events 2 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Psychiatric disorders
Insomnia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
General disorders
Localized Edema (Bilateral Ankles)
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Investigations
Lymphocyte Count Decreased
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia- Left Rib
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Investigations
Neutrophil Count Decreased
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Investigations
Platelet Count Decreased
|
100.0%
1/1 • Number of events 5 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
|
Investigations
White Blood Cell Decreased
|
100.0%
1/1 • Number of events 5 • Adverse Events were collected up to 8 months during the study was conducted.
Toxicities were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
|
Additional Information
Dr. Yvonne Efebera
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-7243
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place