Trial Outcomes & Findings for Thalidomide, Lenalidomide, and Rituximab for Previously Treated Waldenstrom Macroglobulinemia (NCT NCT01779167)

NCT ID: NCT01779167

Last Updated: 2018-07-11

Results Overview

Response criteria for subjects with WM is based upon the Consensus Panel Recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia. Overall response rate (CR + PR + MR) measured at time of best response.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Approximately 24 months

Results posted on

2018-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 \& 27) Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 \& 28). Lenalidomide will be initiated at a starting dose of 5 mg. Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc).
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thalidomide, Lenalidomide, and Rituximab for Previously Treated Waldenstrom Macroglobulinemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=3 Participants Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 \& 27) Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 \& 28). Lenalidomide will be initiated at a starting dose of 5 mg. Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc).
Age, Customized 50-59	1 Participants n=5 Participants
Age, Customized 60-69	1 Participants n=5 Participants
Age, Customized 80-89	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 24 months

Response criteria for subjects with WM is based upon the Consensus Panel Recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia. Overall response rate (CR + PR + MR) measured at time of best response.

Outcome measures

Outcome measures
Measure	All Patients n=3 Participants Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 \& 27) Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 \& 28). Lenalidomide will be initiated at a starting dose of 5 mg. Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc).
Number of Patients Who Demonstrate a Response (Complete, Partial, Minor) to Treatment	0 participants

SECONDARY outcome

Timeframe: approximately 24 months per patient

Population: Data was not collected due to early termination.

Capture the number of adverse events experienced when combining thalidomide, lenalidomide, and rituximab in patients with previously treated WM

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: approximately 24 months per patient

Population: Data was not collected due to early termination.

Estimate overall survival of patients enrolled on THRiL for WM.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months per patient

Population: Data was not collected due to early termination.

Estimate the rate of rituximab-related IgM flare

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: approximately 24 months

Population: Data was not collected due to early termination.

Measure the time from initiating therapy to demonstrating response in WM.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Data was not collected due to early termination.

Measure response duration of patients enrolled on THRiL for WM

Outcome measures

Outcome data not reported

Adverse Events

All Patients

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=3 participants at risk；n=4 participants at risk Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 \& 27) Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 \& 28). Lenalidomide will be initiated at a starting dose of 5 mg. Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc).
Nervous system disorders Vasovagal Reaction	25.0% 1/4
General disorders Unconsciousness	25.0% 1/4
Gastrointestinal disorders Gastrointestinal stromal tumor	25.0% 1/4
Respiratory, thoracic and mediastinal disorders Sick Sinus Syndrome	25.0% 1/4
Nervous system disorders Transient Ischemic Attacks	25.0% 1/4

Other adverse events

Other adverse events
Measure	All Patients n=3 participants at risk；n=4 participants at risk Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 \& 27) Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 \& 28). Lenalidomide will be initiated at a starting dose of 5 mg. Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc).
Blood and lymphatic system disorders Anemia	66.7% 2/3 • Number of events 5
Blood and lymphatic system disorders Neutropenia	100.0% 3/3 • Number of events 17
Blood and lymphatic system disorders Intermittent Creatinine increased	33.3% 1/3 • Number of events 1
Blood and lymphatic system disorders Thrombocytopenia	66.7% 2/3 • Number of events 3
Blood and lymphatic system disorders Hyperuricemia	33.3% 1/3 • Number of events 1
Blood and lymphatic system disorders Lymphocyte count decreased	66.7% 2/3 • Number of events 9
Blood and lymphatic system disorders Creatinine increased	66.7% 2/3 • Number of events 2
General disorders Fatigue (worsened)	33.3% 1/3 • Number of events 3
General disorders aphasia	33.3% 1/3 • Number of events 1

Additional Information

Peter Martin, MD

Weill Cornell Medicine

Phone: 646.962.2064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place