Trial Outcomes & Findings for Revlimid in Transfusion Dependent Patients (NCT NCT01178814)
NCT ID: NCT01178814
Last Updated: 2024-06-24
Results Overview
The trial will be testing the Revlimid® (lenalidomide) response signature in patients who have transfusion dependent, non-del(5q), low and intermediate-1 risk myelodysplastic syndromes (MDS) in order to confirm the predictive value of the signature and to establish the boundaries of the z-score which can be used to pre-select patients in future clinical studies. 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.
COMPLETED
PHASE2
57 participants
Up to 12 weeks from baseline
2024-06-24
Participant Flow
Participant milestones
| Measure |
Revlimid
Revlimid (Lenalidomide) capsule taken orally once a day
Revlimid (Lenalidomide): The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Revlimid in Transfusion Dependent Patients
Baseline characteristics by cohort
| Measure |
Revlimid
n=57 Participants
Revlimid (Lenalidomide) capsule taken orally once a day
Revlimid (Lenalidomide): The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
36 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeks from baselineThe trial will be testing the Revlimid® (lenalidomide) response signature in patients who have transfusion dependent, non-del(5q), low and intermediate-1 risk myelodysplastic syndromes (MDS) in order to confirm the predictive value of the signature and to establish the boundaries of the z-score which can be used to pre-select patients in future clinical studies. 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.
Outcome measures
| Measure |
Revlimid
n=57 Participants
Revlimid (Lenalidomide) capsule taken orally once a day
Revlimid (Lenalidomide): The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks.
|
|---|---|
|
Response Signature in Transfusion Dependent MDS Patients
No response
|
24 Participants
|
|
Response Signature in Transfusion Dependent MDS Patients
Delayed response
|
1 Participants
|
|
Response Signature in Transfusion Dependent MDS Patients
Complete Response (CR)
|
17 Participants
|
|
Response Signature in Transfusion Dependent MDS Patients
Partial Response (PR)
|
6 Participants
|
|
Response Signature in Transfusion Dependent MDS Patients
Other response
|
9 Participants
|
Adverse Events
Revlimid
Serious adverse events
| Measure |
Revlimid
n=57 participants at risk
Revlimid (Lenalidomide) capsule taken orally once a day
Revlimid (Lenalidomide): The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/57 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/57 • Up to 3 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.8%
1/57 • Up to 3 months
|
Other adverse events
| Measure |
Revlimid
n=57 participants at risk
Revlimid (Lenalidomide) capsule taken orally once a day
Revlimid (Lenalidomide): The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
3/57 • Up to 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
7.0%
4/57 • Up to 3 months
|
|
Investigations
Platelet count abnormality
|
7.0%
4/57 • Up to 3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.0%
4/57 • Up to 3 months
|
Additional Information
Mark Heaney, MD
Columbia University Irving Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place