Trial Outcomes & Findings for Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma (NCT NCT01380106)

Last Updated: 2021-01-25

Results Overview

Type, frequency, severity and timing of adverse events and their relationship to combination therapy with lenalidomide plus dexamethasone. SAE Grade 3 indicates a severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization; disabling; limiting self care ADL SAE Grade 4 indicates a life-threatening consequences; urgent intervention indicated. SAE Grade 5 Death related to AE.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.

Results posted on

2021-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Lenalidomide 25mg Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle	Lenalidomide 15mg Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
Overall Study STARTED	16	17
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide 25mg n=16 Participants Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle	Lenalidomide 15mg n=17 Participants Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	17 participants n=7 Participants	33 participants n=5 Participants
M-protein	3.12 g/dL n=5 Participants	2.74 g/dL n=7 Participants	2.93 g/dL n=5 Participants

PRIMARY outcome

Timeframe: Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.

Population: 33

Outcome measures

Outcome measures
Measure	Lenalidomide 25mg n=16 Participants Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle	Lenalidomide 15mg n=17 Participants Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
Serious Adverse Events SAE Grade 4	4 Events	1 Events
Serious Adverse Events SAE Grade 3	23 Events	23 Events
Serious Adverse Events SAE Grade 5	1 Events	0 Events

PRIMARY outcome

Timeframe: Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.

Population: 33

Number of days between the first day of the first cycle to best M-protein response, at least Minimal Response or higher (Partial Response, Very Good Partial Response, near Complete Response, Complete Response).

Outcome measures

Outcome measures
Measure	Lenalidomide 25mg n=16 Participants Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle	Lenalidomide 15mg n=17 Participants Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
Duration Until Best Response (at Least MR or Minimal Response)	280.4 Days Interval 86.6 to 474.3	145.5 Days Interval 75.7 to 215.3

Adverse Events

Lenalidomide 25mg

Serious events: 12 serious events

Other events: 0 other events

Deaths: 1 deaths

Lenalidomide 15mg

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Nikhil C. Munshi, M.D.

Boston VA Research Institute, Inc.

Phone: 6176325607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Lenalidomide 25mg n=16 participants at risk Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle	Lenalidomide 15mg n=17 participants at risk Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
Cardiac disorders DVT	12.5% 2/16 • Number of events 2 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	11.8% 2/17 • Number of events 2 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
General disorders Loss of consciousness	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Gastrointestinal disorders Hematochezia	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Blood and lymphatic system disorders Anemia	12.5% 2/16 • Number of events 2 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	11.8% 2/17 • Number of events 2 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Infections and infestations Pneumonia	25.0% 4/16 • Number of events 4 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	17.6% 3/17 • Number of events 3 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Respiratory, thoracic and mediastinal disorders COPD	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	5.9% 1/17 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/16 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	11.8% 2/17 • Number of events 2 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/16 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	5.9% 1/17 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Respiratory, thoracic and mediastinal disorders Death	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Blood and lymphatic system disorders Rectal adenocarcinoma	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Musculoskeletal and connective tissue disorders Back pain	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	5.9% 1/17 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Metabolism and nutrition disorders Potassium level change	12.5% 2/16 • Number of events 2 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Infections and infestations Alpha strep infection	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Metabolism and nutrition disorders Electrolyte imbalance	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Musculoskeletal and connective tissue disorders Bursitis	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Musculoskeletal and connective tissue disorders Chest pain	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	5.9% 1/17 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Respiratory, thoracic and mediastinal disorders Hypercapnic respiratory failure	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Cardiac disorders Coronary ischemia	0.00% 0/16 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	5.9% 1/17 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/16 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	5.9% 1/17 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Gastrointestinal disorders Diarrhea	0.00% 0/16 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	5.9% 1/17 • Number of events 2 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Endocrine disorders Decreased urination	0.00% 0/16 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	5.9% 1/17 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Blood and lymphatic system disorders Pulmonary Embolism	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Metabolism and nutrition disorders Low calcium	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Nervous system disorders Neutropenia	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	17.6% 3/17 • Number of events 3 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Respiratory, thoracic and mediastinal disorders GERD (suspected)	6.2% 1/16 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	0.00% 0/17 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Musculoskeletal and connective tissue disorders Gastric Pain	0.00% 0/16 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	5.9% 1/17 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Psychiatric disorders Altered mental state	0.00% 0/16 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	5.9% 1/17 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Gastrointestinal disorders Appendicitis	0.00% 0/16 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.	5.9% 1/17 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.