Trial Outcomes & Findings for Lenalidomide and Darbepoetin in Low-Intermediate Risk Myelodysplastic Syndrome (MDS) (NCT NCT01222195)

Results Overview

Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Over six 28-day cycles (approximately 168 days)

Results posted on

2012-08-07

Recruitment Period: 2/22/2009 to 4/20/2010. All patients were registered at The University of Texas M.D. Anderson Cancer Center.

Study terminated due to low accrual, one patient registered on study.

Participant milestones
Measure	Lenalidomide + Darbepoetin Alfa Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Lenalidomide and Darbepoetin in Low-Intermediate Risk Myelodysplastic Syndrome (MDS)

Baseline characteristics by cohort
Measure	Lenalidomide + Darbepoetin Alfa n=1 Participants Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
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	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

Timeframe: Over six 28-day cycles (approximately 168 days)

Population: Analysis was per protocol.

Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.

Outcome measures
Measure	Lenalidomide + Darbepoetin Alfa n=1 Participants Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
Number of Patients With a Transfusion Independence Response	0 participants

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events
Measure	Lenalidomide + Darbepoetin Alfa n=1 participants at risk Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
Infections and infestations Neutropenic fever	100.0% 1/1 • Number of events 1 • 1 year 4 months

Other adverse events
Measure	Lenalidomide + Darbepoetin Alfa n=1 participants at risk Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
General disorders fatigue	100.0% 1/1 • Number of events 1 • 1 year 4 months
Cardiac disorders Bilateral edema	100.0% 1/1 • Number of events 1 • 1 year 4 months
General disorders Bone Pain	100.0% 1/1 • Number of events 1 • 1 year 4 months

The University of Texas M. D. Anderson Cancer Center

Phone: 713-792-7305