Trial Outcomes & Findings for Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance (NCT NCT01463670)

Last Updated: 2022-05-06

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

6 months

Results posted on

2022-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Lenalidomide The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide n=11 Participants The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.
Age, Continuous	65 years n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants
Region of Enrollment United States	11 Participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Population: A total of 10 patients were evaluable for the primary endpoint of response.

Outcome measures

Outcome measures
Measure	Lenalidomide n=10 Participants The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.
Overall Response Rate (ORR) Partial Response	1 participants
Overall Response Rate (ORR) Minor Response	1 participants
Overall Response Rate (ORR) Stable Disease	7 participants
Overall Response Rate (ORR) Progression of Disease	1 participants

SECONDARY outcome

Timeframe: every 28 days before initiation of a new cycle through study completion until disease progression up to 5 years

All toxicities with a maximum grade and status of ≥ grade 2 will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Outcome measures

Outcome measures
Measure	Lenalidomide n=11 Participants The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.
Number of Participants Evaluated for Toxicity	11 Participants

Adverse Events

Lenalidomide

Serious events: 6 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Lenalidomide n=11 participants at risk The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	9.1% 1/11 • 2 years
Cardiac disorders Atrial fibrillation	9.1% 1/11 • 2 years
Eye disorders Blurred Vision	9.1% 1/11 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 1/11 • 2 years
General disorders Fever	9.1% 1/11 • 2 years
Infections and infestations Lung infection	18.2% 2/11 • 2 years
Infections and infestations Sepsis	9.1% 1/11 • 2 years
Infections and infestations Skin infection	9.1% 1/11 • 2 years
Vascular disorders Thromboembolic event	18.2% 2/11 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hani Hassoun MD

Memorial Sloan Kettering Cancer Center

Phone: 646-608-3718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place