Trial Outcomes & Findings for REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas (NCT NCT00287287)

NCT ID: NCT00287287

Last Updated: 2020-06-12

Results Overview

Percentage of patients who responded to treatment (either stable disease or complete response) based on total tumor volume measurements from CT scans.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: 4 years
• Results posted on: 2020-06-12

Participant Flow

Participant milestones

Measure	Lenalidomide (Revlimid) Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities. Lenalidomide: Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas

Baseline characteristics by cohort

Measure	Lenalidomide (Revlimid) n=25 Participants Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities. Lenalidomide: Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day
Age, Continuous	60.2 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 years

Percentage of patients who responded to treatment (either stable disease or complete response) based on total tumor volume measurements from CT scans.

Outcome measures

Measure	Lenalidomide (Revlimid) n=25 Participants Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.
Response Rate	17 Participants

Adverse Events

Lenalidomide (Revlimid)

Serious events: 25 serious events

Other events: 3 other events

Deaths: 25 deaths

Serious adverse events

Measure	Lenalidomide (Revlimid) n=25 participants at risk Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.
Blood and lymphatic system disorders Neutropenia	40.0% 10/25 • 4 years Serious adverse events were defined as Grade 3 or higher.
Blood and lymphatic system disorders Leukopenia	24.0% 6/25 • 4 years Serious adverse events were defined as Grade 3 or higher.
Blood and lymphatic system disorders Thrombocytopenia	16.0% 4/25 • 4 years Serious adverse events were defined as Grade 3 or higher.
Blood and lymphatic system disorders Anemia	4.0% 1/25 • 4 years Serious adverse events were defined as Grade 3 or higher.
Blood and lymphatic system disorders Idiopathic Thrombocytopenic Purpura	4.0% 1/25 • 4 years Serious adverse events were defined as Grade 3 or higher.
Social circumstances Rash	4.0% 1/25 • 4 years Serious adverse events were defined as Grade 3 or higher.
Vascular disorders Pulmonary Embolism	8.0% 2/25 • 4 years Serious adverse events were defined as Grade 3 or higher.
Respiratory, thoracic and mediastinal disorders Pneumonia	4.0% 1/25 • 4 years Serious adverse events were defined as Grade 3 or higher.

Other adverse events

Measure	Lenalidomide (Revlimid) n=25 participants at risk Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.
Skin and subcutaneous tissue disorders Rash	4.0% 1/25 • 4 years Serious adverse events were defined as Grade 3 or higher.
General disorders Fatigue	4.0% 1/25 • 4 years Serious adverse events were defined as Grade 3 or higher.
General disorders Weight Loss	4.0% 1/25 • 4 years Serious adverse events were defined as Grade 3 or higher.

Additional Information

Kenneth Ain

University of Kentucky

Phone: 8593236652

Email: kenneth.ain@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place