Trial Outcomes & Findings for Lenalidomide Maintenance Therapy for Multiple Myeloma (NCT NCT01675141)
NCT ID: NCT01675141
Last Updated: 2018-02-05
Results Overview
Peripheral blood samples will be collected to assess T cell (CD4, CD8), NKT and NK cell counts using flow cytometry.
TERMINATED
PHASE2
11 participants
participants were followed for the duration of their treatment, an average of 2 years
2018-02-05
Participant Flow
Participant milestones
| Measure |
Lenalidomide Maintenance Therapy for Multiple Myeloma
10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Lenalidomide Maintenance Therapy for Multiple Myeloma
10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Lenalidomide outside NIH
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
No treatment, per protocol
|
1
|
Baseline Characteristics
Lenalidomide Maintenance Therapy for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Lenalidomide Maintenance Therapy for Multiple Myeloma
n=11 Participants
10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
57.05 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mexican, Cuban, Puerto Rican, Central/So. American
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: participants were followed for the duration of their treatment, an average of 2 yearsPopulation: This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.
Peripheral blood samples will be collected to assess T cell (CD4, CD8), NKT and NK cell counts using flow cytometry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 37 months and 12 daysHere is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Lenalidomide Maintenance Therapy for Multiple Myeloma
n=11 Participants
10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events
|
11 Participants
|
SECONDARY outcome
Timeframe: participants were followed for the duration of their treatment, an average of 2 yearsDuration of response is defined as time from response to disease progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be \>10mg/dl.
Outcome measures
| Measure |
Lenalidomide Maintenance Therapy for Multiple Myeloma
n=10 Participants
10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Response
|
NA Months
Interval 0.9 to
The median and upper limit of 95% CI is NR (not reached). The median and upper limit were not reached because there was not enough follow up time to reach a median or upper limit.
|
SECONDARY outcome
Timeframe: participants were followed for the duration of their treatment, an average of 2 yearsPFS is defined as the time from study entry until progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be \>10mg/dl.
Outcome measures
| Measure |
Lenalidomide Maintenance Therapy for Multiple Myeloma
n=11 Participants
10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
|
|---|---|
|
Progression Free Survival (PFS)
|
NA months
Interval 16.2 to
The median and upper limit of 95% CI is NR (not reached). The median and upper limit were not reached because there was not enough follow up time to reach a median or upper limit.
|
SECONDARY outcome
Timeframe: participants were followed for the duration of their treatment, an average of 2 yearsPopulation: This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.
Percent of target cell lysis by NK cells
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: participants were followed for the duration of their treatment, an average of 2 yearsPopulation: This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.
Percent change in total number of B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: participants were followed for the duration of their treatment, an average of 2 yearsPopulation: This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.
Relative fold change in CRBN and correlation (R2) to NK cell number and activity.
Outcome measures
Outcome data not reported
Adverse Events
Lenalidomide Maintenance Therapy for Multiple Myeloma
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lenalidomide Maintenance Therapy for Multiple Myeloma
n=11 participants at risk
10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
|
|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
18.2%
2/11 • Number of events 2 • 37 months and 12 days
|
|
Investigations
Alanine aminotransferase increased
|
36.4%
4/11 • Number of events 6 • 37 months and 12 days
|
|
Investigations
Alkaline phosphatase increased
|
36.4%
4/11 • Number of events 6 • 37 months and 12 days
|
|
Blood and lymphatic system disorders
Anemia
|
45.5%
5/11 • Number of events 11 • 37 months and 12 days
|
|
Investigations
Aspartate aminotransferase increased
|
36.4%
4/11 • Number of events 9 • 37 months and 12 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.2%
2/11 • Number of events 2 • 37 months and 12 days
|
|
Investigations
Blood bilirubin increased
|
18.2%
2/11 • Number of events 3 • 37 months and 12 days
|
|
Investigations
CPK increased
|
27.3%
3/11 • Number of events 6 • 37 months and 12 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • Number of events 2 • 37 months and 12 days
|
|
Investigations
Creatinine increased
|
45.5%
5/11 • Number of events 11 • 37 months and 12 days
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11 • Number of events 2 • 37 months and 12 days
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
36.4%
4/11 • Number of events 4 • 37 months and 12 days
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
General disorders
Edema face
|
9.1%
1/11 • Number of events 2 • 37 months and 12 days
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 3 • 37 months and 12 days
|
|
General disorders
Fever
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
General disorders
Flu like symptoms
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Metabolism and nutrition disorders
Hypernatremia
|
18.2%
2/11 • Number of events 3 • 37 months and 12 days
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
27.3%
3/11 • Number of events 4 • 37 months and 12 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.2%
2/11 • Number of events 2 • 37 months and 12 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.2%
2/11 • Number of events 2 • 37 months and 12 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
36.4%
4/11 • Number of events 6 • 37 months and 12 days
|
|
Infections and infestations
Infections and infestations - Other, dental abscess
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Infections and infestations
Lung infection
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Investigations
Lymphocyte count decreased
|
72.7%
8/11 • Number of events 18 • 37 months and 12 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
45.5%
5/11 • Number of events 5 • 37 months and 12 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, primary prostate cancer
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Investigations
Neutrophil count decreased
|
72.7%
8/11 • Number of events 25 • 37 months and 12 days
|
|
General disorders
Pain
|
9.1%
1/11 • Number of events 3 • 37 months and 12 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Nervous system disorders
Paresthesia
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.2%
2/11 • Number of events 2 • 37 months and 12 days
|
|
Investigations
Platelet count decreased
|
36.4%
4/11 • Number of events 9 • 37 months and 12 days
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
2/11 • Number of events 2 • 37 months and 12 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.2%
2/11 • Number of events 3 • 37 months and 12 days
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Infections and infestations
Skin infection
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Nervous system disorders
Somnolence
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Infections and infestations
Upper respiratory infection
|
18.2%
2/11 • Number of events 2 • 37 months and 12 days
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Eye disorders
Watering eyes
|
9.1%
1/11 • Number of events 1 • 37 months and 12 days
|
|
Investigations
White blood cell decreased
|
90.9%
10/11 • Number of events 29 • 37 months and 12 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place