Trial Outcomes & Findings for Lenalidomide Therapy After Chemotherapy & Stem Cell Transplant in Treating Chemotherapy Resistan Non-Hodgkin Lymphoma (NCT NCT01035463)

Last Updated: 2023-10-10

Results Overview

The Maximum Tolerated Dose (MTD) is defined to be the dose cohort below which 3 out of 6 subjects experience dose limiting toxicities during cycle 1. Dose limiting toxicities graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

74 participants

Primary outcome timeframe

Cycle 1, 28 days

Results posted on

2023-10-10

Participant Flow

74 participants were consented, but only 59 subjects were treated on the study.

Participant milestones

Participant milestones
Measure	Phase I - 10 mg Len AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 - 15 mg Len AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 - 20 mg Len AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 - 25mg Len AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	Phase II - 15 mg Len Based in Phase I data, the MTD was determined to be 15 mg but, the MTD for the study was based on cycle 1 of the Lenalidomide maintenance. However, there is cumulative toxicity of Lenalidomide, especially in the post-transplant setting which led to a need to lower the dose to 10 mg for the Phase II study. At the 10 mg dose, a much higher percentage of subjects were able to complete \> 6 months of maintenance therapy. Therefore the dose for continued Phase II will be 10 mg.	Phase II - 10 mg Len Based in Phase I data, the MTD was determined to be 15 mg but, the MTD for the study was based on cycle 1 of the Lenalidomide maintenance. However, there is cumulative toxicity of Lenalidomide, especially in the post-transplant setting which led to a need to lower the dose to 10 mg for the Phase II study. At the 10 mg dose, a much higher percentage of subjects were able to complete \> 6 months of maintenance therapy. Therefore the dose for continued Phase II will be 10 mg.
Overall Study STARTED	6	3	6	4	7	33
Overall Study COMPLETED	6	1	1	2	1	15
Overall Study NOT COMPLETED	0	2	5	2	6	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 - 15 mg Len AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 - 20 mg Len AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 - 25mg Len AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	Phase II - 15 mg Len Based in Phase I data, the MTD was determined to be 15 mg but, the MTD for the study was based on cycle 1 of the Lenalidomide maintenance. However, there is cumulative toxicity of Lenalidomide, especially in the post-transplant setting which led to a need to lower the dose to 10 mg for the Phase II study. At the 10 mg dose, a much higher percentage of subjects were able to complete \> 6 months of maintenance therapy. Therefore the dose for continued Phase II will be 10 mg.	Phase II - 10 mg Len Based in Phase I data, the MTD was determined to be 15 mg but, the MTD for the study was based on cycle 1 of the Lenalidomide maintenance. However, there is cumulative toxicity of Lenalidomide, especially in the post-transplant setting which led to a need to lower the dose to 10 mg for the Phase II study. At the 10 mg dose, a much higher percentage of subjects were able to complete \> 6 months of maintenance therapy. Therefore the dose for continued Phase II will be 10 mg.
Overall Study Adverse Event	0	4	1	5	7
Overall Study Withdrawal by Subject	2	1	0	1	4
Overall Study Disease progression	0	0	0	0	3
Overall Study Other Malignancy	0	0	0	0	2
Overall Study Other	0	0	1	0	2

Baseline Characteristics

Lenalidomide Therapy After Chemotherapy & Stem Cell Transplant in Treating Chemotherapy Resistan Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Phase I Participants n=19 Participants AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION	All Phase II Participants n=40 Participants AUTOLOGOUS HEMATOPOIETIC STEM CELL	Total n=59 Participants Total of all reporting groups
Age, Continuous	56.9 years STANDARD_DEVIATION 7.8 • n=5 Participants	58.1 years STANDARD_DEVIATION 9.9 • n=7 Participants	57.7 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	31 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	19 Participants n=5 Participants	38 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	40 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: Cycle 1, 28 days

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Transplantation) n=19 Participants Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	All Phase II Participants Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Maximum Tolerated Dose of Lenalidomide (Phase I)	10 milligrams PO daily	—

SECONDARY outcome

Timeframe: 1 year

The Kaplan-Meier method will be used to estimate the event-free survival distribution.

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Transplantation) n=19 Participants Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	All Phase II Participants n=40 Participants Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Event-free Survival	84 percentage of participants Interval 59.0 to 95.0	87 percentage of participants Interval 73.0 to 95.0

SECONDARY outcome

Timeframe: 1 year

The Kaplan-Meier method will be used to estimate the overall survival distribution. This outcome only reports data as it pertains to overall survival at one year. All-cause mortality includes survival for follow up for all subjects on the study.

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Transplantation) n=19 Participants Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	All Phase II Participants n=40 Participants Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Survival	100 percentage of participants Interval 100.0 to 100.0	95 percentage of participants Interval 81.0 to 99.0

Adverse Events

All Phase I Participants

Serious events: 9 serious events

Other events: 14 other events

Deaths: 4 deaths

All Phase II Participants

Serious events: 6 serious events

Other events: 24 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	All Phase I Participants n=19 participants at risk Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	All Phase II Participants n=40 participants at risk Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders abdominal pain	5.3% 1/19 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	0.00% 0/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Infections and infestations acute hepatitis	5.3% 1/19 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	0.00% 0/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Hepatobiliary disorders Hepatobiliary disorders - Other	5.3% 1/19 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	0.00% 0/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Infections and infestations bronchial infection	5.3% 1/19 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	0.00% 0/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Surgical and medical procedures Surgical and medical procedures - Other	5.3% 1/19 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	0.00% 0/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Metabolism and nutrition disorders dehydration	5.3% 1/19 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	0.00% 0/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Blood and lymphatic system disorders Febrile neutropenia	5.3% 1/19 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	0.00% 0/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Gastrointestinal disorders rectal hemorrhage	5.3% 1/19 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	0.00% 0/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Skin and subcutaneous tissue disorders skin and subcutaneous tissue disorder - Other	5.3% 1/19 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	2.5% 1/40 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Infections and infestations Enterocolitis infectious	0.00% 0/19 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	2.5% 1/40 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Investigations Neutrophil count decreased	0.00% 0/19 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	2.5% 1/40 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Infections and infestations Infection and infestation, Other	0.00% 0/19 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	2.5% 1/40 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Nervous system disorders Transient ischemic attack	0.00% 0/19 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	2.5% 1/40 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Respiratory, thoracic and mediastinal disorders Respiratory, throacic and mediastinal, Other	0.00% 0/19 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	2.5% 1/40 • Number of events 1 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.

Other adverse events

Other adverse events
Measure	All Phase I Participants n=19 participants at risk Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.	All Phase II Participants n=40 participants at risk Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Investigations neutrophil count decreased	52.6% 10/19 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	37.5% 15/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Investigations platelet count decreased	31.6% 6/19 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	5.0% 2/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Investigations white blood cell decreased	26.3% 5/19 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	12.5% 5/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
Skin and subcutaneous tissue disorders rash	0.00% 0/19 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.	5.0% 2/40 • All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.

Additional Information

Julie M Vose

University of Nebraska Medical Center

Phone: 402-559-3848

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place