Trial Outcomes & Findings for Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165 (NCT NCT02507336)

NCT ID: NCT02507336

Last Updated: 2024-08-01

Results Overview

PFS is defined as the length of time, during and after treatment, until documented disease progression or death (by any cause, in the absence of progression).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: Up to five years
• Results posted on: 2024-08-01

Participant Flow

Participant milestones

Measure	Group A - CR+Thalidomide Patients who achieved complete response (CR) in 20030165 and continue to receive maintenance Thalidomide. Patients in Group A will receive daily oral thalidomide (THALOMID®) as per standard of care and THALOMID® REMS™ guidelines. Patients will continue with thalidomide (THALOMID®) as per standard of care guidelines, until progression of disease, discontinuation due to toxicity, death or study withdrawal. Patients will receive annual clinical/laboratory evaluations. Thalidomide: 100-300 mg capsule taken by mouth once daily.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165

Baseline characteristics by cohort

Measure	Group A - CR+Thalidomide n=2 Participants Patients who achieved complete response (CR) in 20030165 and continue to receive maintenance Thalidomide. Patients in Group A will receive daily oral thalidomide (THALOMID®) as per standard of care and THALOMID® REMS™ guidelines. Patients will continue with thalidomide (THALOMID®) as per standard of care guidelines, until progression of disease, discontinuation due to toxicity, death or study withdrawal. Patients will receive annual clinical/laboratory evaluations. Thalidomide: 100-300 mg capsule taken by mouth once daily.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 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	0 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	2 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

PRIMARY outcome

Timeframe: Up to five years

PFS is defined as the length of time, during and after treatment, until documented disease progression or death (by any cause, in the absence of progression).

Outcome measures

Measure

Group A - CR+Thalidomide n=2 Participants Patients who achieved complete response (CR) in 20030165 and continue to receive maintenance Thalidomide. Patients in Group A will receive daily oral thalidomide (THALOMID®) as per standard of care and THALOMID® REMS™ guidelines. Patients will continue with thalidomide (THALOMID®) as per standard of care guidelines, until progression of disease, discontinuation due to toxicity, death or study withdrawal. Patients will receive annual clinical/laboratory evaluations. Thalidomide: 100-300 mg capsule taken by mouth once daily.

Progression-free Survival (PFS)

NA years Results not reported due to participant confidentiality.

SECONDARY outcome

Timeframe: Up to five years

Population: Results not reported due to participant confidentiality.

OS is defined as the elapsed time from start of treatment until death or date of censoring.

Outcome measures

Measure

Group A - CR+Thalidomide n=2 Participants Patients who achieved complete response (CR) in 20030165 and continue to receive maintenance Thalidomide. Patients in Group A will receive daily oral thalidomide (THALOMID®) as per standard of care and THALOMID® REMS™ guidelines. Patients will continue with thalidomide (THALOMID®) as per standard of care guidelines, until progression of disease, discontinuation due to toxicity, death or study withdrawal. Patients will receive annual clinical/laboratory evaluations. Thalidomide: 100-300 mg capsule taken by mouth once daily.

Overall Survival (OS)

NA years Results not reported due to participant confidentiality.

SECONDARY outcome

Timeframe: Up to five years

Response rate is defined as the percentage of participants whose cancer shrinks or disappears after treatment.

Outcome measures

Measure

Group A - CR+Thalidomide n=2 Participants Patients who achieved complete response (CR) in 20030165 and continue to receive maintenance Thalidomide. Patients in Group A will receive daily oral thalidomide (THALOMID®) as per standard of care and THALOMID® REMS™ guidelines. Patients will continue with thalidomide (THALOMID®) as per standard of care guidelines, until progression of disease, discontinuation due to toxicity, death or study withdrawal. Patients will receive annual clinical/laboratory evaluations. Thalidomide: 100-300 mg capsule taken by mouth once daily.

Response Rate (RR)

NA percentage of participants Results not reported due to participant confidentiality.

SECONDARY outcome

Timeframe: Up to five years

Treatment emergent adverse events will be assessed by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0.

Outcome measures

Measure

Group A - CR+Thalidomide n=2 Participants Patients who achieved complete response (CR) in 20030165 and continue to receive maintenance Thalidomide. Patients in Group A will receive daily oral thalidomide (THALOMID®) as per standard of care and THALOMID® REMS™ guidelines. Patients will continue with thalidomide (THALOMID®) as per standard of care guidelines, until progression of disease, discontinuation due to toxicity, death or study withdrawal. Patients will receive annual clinical/laboratory evaluations. Thalidomide: 100-300 mg capsule taken by mouth once daily.

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

NA percentage of participants Results not reported due to participant confidentiality.

Adverse Events

Group A - CR+Thalidomide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Izidore Lossos MD

University of Miami

Phone: +1 (305) 2434785

Email: ilossos@med.miami.edu

Results disclosure agreements

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