Trial Outcomes & Findings for A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL). (NCT NCT01021423)

Last Updated: 2019-11-19

Results Overview

PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir. Study terminated prematurely. Analysis not conducted.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

9 participants

Primary outcome timeframe

up to 7 years

Results posted on

2019-11-19

Participant Flow

Randomization was stratified according to 1) the type of first-line induction chemotherapy (anthracycline-based, fludarabine-based, or rituximab-bendamustine combination therapy) and 2) the response to first-line induction chemotherapy (complete response or partial response).

Participant milestones

Participant milestones
Measure	Lenalidomide Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.	Placebo Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Overall Study STARTED	4	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenalidomide Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.	Placebo Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Overall Study Study terminated	4	5

Baseline Characteristics

A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide n=4 Participants Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.	Placebo n=5 Participants Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.	Total n=9 Participants Total of all reporting groups
Age, Continuous	77.8 years STANDARD_DEVIATION 4.65 • n=5 Participants	73.0 years STANDARD_DEVIATION 6.89 • n=7 Participants	75.1 years STANDARD_DEVIATION 6.17 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Status = 0	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Status = 1	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Response of Mantle Cell Lymphoma (MCL) to chemotherapy at enrollment Complete response	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Response of Mantle Cell Lymphoma (MCL) to chemotherapy at enrollment Partial response	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 7 years

Population: Study terminated prematurely. Analysis not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 7 years

Population: Study terminated prematurely. Analysis not performed.

Overall survival was defined as the time from randomization to death from any cause. Study terminated prematurely. Analysis not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 9 months

Population: Safety population of participants who received at least one dose of study drug

Participants with treatment-emergent adverse events (TEAEs) during the treatment period plus 30 days. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator. The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE.

Outcome measures

Outcome measures
Measure	Lenalidomide n=4 Participants Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.	Placebo n=5 Participants Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Participants With Treatment Emergent Adverse Events (TEAEs) At least one NCI CTC grade 3-4 related to drug	1 participants	1 participants
Participants With Treatment Emergent Adverse Events (TEAEs) Related TEAE leading to discontinuation of drug	1 participants	0 participants
Participants With Treatment Emergent Adverse Events (TEAEs) At least one TEAE	4 participants	4 participants
Participants With Treatment Emergent Adverse Events (TEAEs) At least one TEAE related to study drug	3 participants	2 participants
Participants With Treatment Emergent Adverse Events (TEAEs) At least one NCI CTC grade 3-4 TEAE	1 participants	1 participants
Participants With Treatment Emergent Adverse Events (TEAEs) At least one serious TEAE	1 participants	0 participants
Participants With Treatment Emergent Adverse Events (TEAEs) At least one serious TEAE related to drug	1 participants	0 participants
Participants With Treatment Emergent Adverse Events (TEAEs) TEAE leading to discontinuation of drug	1 participants	0 participants
Participants With Treatment Emergent Adverse Events (TEAEs) TEAE leading to dose reduction or interruption	1 participants	1 participants
Participants With Treatment Emergent Adverse Events (TEAEs) Related TEAE - dose reduction or interruption	1 participants	1 participants

SECONDARY outcome

Timeframe: up to 7 years

Population: Study terminated prematurely. Analysis not conducted.

Time to progression was defined as the time from the date of randomization until the first date of documented disease progression. Study terminated prematurely. Analysis not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 years

Population: Study terminated prematurely. Analysis not conducted.

Time to treatment failure was defined as the time from randomization until the date at which a participant was removed from treatment due to progression, toxicity, refusal or death or received another Non-Hodgkin Lymphoma (NHL) therapy, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 7 years

Population: Study terminated prematurely. Analysis not conducted.

Number of participants with a measurable tumor at time of randomization who achieve a response. Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007). Study terminated prematurely. Analysis not conducted.

Outcome measures

Outcome data not reported

Adverse Events

Lenalidomide

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lenalidomide n=4 participants at risk Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.	Placebo n=5 participants at risk Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.

Other adverse events

Additional Information

Associate Director, Clinical Trials Disclosure

Celgene Corporation

Phone: 1-888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee * Multicenter publication must include input from investigators and Celgene, agreement to be established before publication. * Multicenter publication has priority over subset (single center) publication, for duration of 1 year after study completion. * Individual investigators have publication right after multicenter publication is complete or 1 year after study completion, whichever is first. Celgene has the right to comment and right to ask delay of publication for up to 90 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Lenalidomide n=4 participants at risk Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.	Placebo n=5 participants at risk Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
General disorders Chills	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
General disorders Oedema peripheral	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Nervous system disorders Dysgeusia	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Nervous system disorders Headache	0.00% 0/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	20.0% 1/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Nervous system disorders Peripheral sensory neuropathy	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Skin and subcutaneous tissue disorders Eczema	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	20.0% 1/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Eye disorders Conjunctivitis	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Musculoskeletal and connective tissue disorders Muscle spasms	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Gastrointestinal disorders Flatulence	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Gastrointestinal disorders Stomatitis	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
General disorders Asthemia	0.00% 0/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	20.0% 1/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Infections and infestations Herpes zoster	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Infections and infestations Herpes zoster ophthalmic	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Infections and infestations Nasopharyngitis	0.00% 0/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	20.0% 1/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Infections and infestations Rhinitis	0.00% 0/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	20.0% 1/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Infections and infestations Viral rash	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Blood and lymphatic system disorders Thrombocytopenia	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	20.0% 1/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Blood and lymphatic system disorders Neutropenia	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Gastrointestinal disorders Constipation	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	20.0% 1/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Gastrointestinal disorders Abdominal pain upper	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Gastrointestinal disorders Dry mouth	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Musculoskeletal and connective tissue disorders Neck pain	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Psychiatric disorders Libido decrease	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Reproductive system and breast disorders Erectile dysfunction	25.0% 1/4 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.	0.00% 0/5 • Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.