Trial Outcomes & Findings for Thalidomide to Overcome Lenalidomide Resistance After Autologous Hematopoietic Stem Cell Transplantation (HCT) (NCT NCT01927718)
NCT ID: NCT01927718
Last Updated: 2019-04-29
Results Overview
Primary endpoint is response rate (RR) measured by the proportion of patients receiving the combination, whose disease stabilizes, or returns to at least its previous response level prior to progression, assessed at 3-months after starting the combination.1.Stringent Complete Remission (sCR): Follows criteria for CR, plus:Normal FLC ratio, Absence of clonal cells in the BM; Complete Remission (CR) All of the following criteria are met:Negative SIFE and UIFE:Disappearance of any soft tissue plasmacytomas:\< 5% plasma cells in the BM. 2.Very Good Partial Response (VGPR):One or more of the following must be present:Serum and urine M-protein detectable by immunofixation but not on electrophoresis:≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours.Partial Response (PR) Both of the following must be present:≥ 50% reduction in SPEP:Reduction in 24-hour UPEP by ≥ 90% or to \< 200 mg/24 hours.3.Stable Disease (SD)Does not meet the criteria for CR, VGPR, PR, or PD.4.Pr
TERMINATED
NA
10 participants
3 months
2019-04-29
Participant Flow
Recruitment Period: January 2014 to august 2016. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Thalidomide + Lenalidomide
Thalidomide 100 mg by mouth daily for 28 days; Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Thalidomide to Overcome Lenalidomide Resistance After Autologous Hematopoietic Stem Cell Transplantation (HCT)
Baseline characteristics by cohort
| Measure |
Thalidomide + Lenalidomide
n=10 Participants
Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPrimary endpoint is response rate (RR) measured by the proportion of patients receiving the combination, whose disease stabilizes, or returns to at least its previous response level prior to progression, assessed at 3-months after starting the combination.1.Stringent Complete Remission (sCR): Follows criteria for CR, plus:Normal FLC ratio, Absence of clonal cells in the BM; Complete Remission (CR) All of the following criteria are met:Negative SIFE and UIFE:Disappearance of any soft tissue plasmacytomas:\< 5% plasma cells in the BM. 2.Very Good Partial Response (VGPR):One or more of the following must be present:Serum and urine M-protein detectable by immunofixation but not on electrophoresis:≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours.Partial Response (PR) Both of the following must be present:≥ 50% reduction in SPEP:Reduction in 24-hour UPEP by ≥ 90% or to \< 200 mg/24 hours.3.Stable Disease (SD)Does not meet the criteria for CR, VGPR, PR, or PD.4.Pr
Outcome measures
| Measure |
Thalidomide + Lenalidomide
n=10 Participants
Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
|
|---|---|
|
Number of Participants With Response
|
2 Participants
|
Adverse Events
Thalidomide + Lenalidomide
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Thalidomide + Lenalidomide
n=10 participants at risk
Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 2 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Number of events 2 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Investigations
Elevated alanine transaminase (ALT)
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Investigations
Elevated Aspartate aminotransferase (AST)
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Investigations
Elevated creatinine
|
40.0%
4/10 • Number of events 4 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
2/10 • Number of events 2 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Investigations
Infection
|
20.0%
2/10 • Number of events 2 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Nervous system disorders
Lethargy
|
20.0%
2/10 • Number of events 2 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Investigations
Loss of balance
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Investigations
Low white blood count
|
20.0%
2/10 • Number of events 2 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramping
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Nervous system disorders
Nerve pain
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
4/10 • Number of events 4 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Nervous system disorders
paraesthesia
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Nervous system disorders
Peripheral neuropathy
|
40.0%
4/10 • Number of events 4 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
10.0%
1/10 • Number of events 1 • Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
|
Additional Information
Qaiser Bashir, MD/Associate Professor, Stem Cell Transplantation
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place