Trial Outcomes & Findings for Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma (NCT NCT00400686)
NCT ID: NCT00400686
Last Updated: 2018-02-22
Results Overview
Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Baseline to Day 28
Results posted on
2018-02-22
Participant Flow
From 9/2003 to 6/2008, a total of 31 patients were enrolled.
Participant milestones
| Measure |
Epoetin Alfa - 80,000 U sc
Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Epoetin Alfa - 80,000 U sc
n=31 Participants
Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
|
|---|---|
|
Age, Continuous
|
61.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.
Outcome measures
| Measure |
Epoetin Alfa - 80,000 U sc
n=31 Participants
Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
|
|---|---|
|
Change From Baseline in Hemoglobin at Day 28
|
1.3 g/dL
Interval -3.0 to 4.4
|
PRIMARY outcome
Timeframe: Baseline to Day 28Outcome measures
| Measure |
Epoetin Alfa - 80,000 U sc
n=31 Participants
Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
|
|---|---|
|
Number of Patients With an at Least 1gm/dL Increase in Hgb
|
13 participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Outcome measures
| Measure |
Epoetin Alfa - 80,000 U sc
n=31 Participants
Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
|
|---|---|
|
Number of Patients With an at Least 2gm/dL Increase in Hgb
|
9 participants
|
Adverse Events
Epoetin Alfa - 80,000 U sc
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epoetin Alfa - 80,000 U sc
n=31 participants at risk
Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
|
|---|---|
|
Blood and lymphatic system disorders
Venous Thromboembolic Event (VTE)
|
9.7%
3/31 • Number of events 3 • AE data highlights development of VTEs in patients receiving one of the following: 1. lenalidomide, high dose dexamethasone & Aspirin 325mg daily 2. thalidomide & doxil based therapy with aspirin 81mg daily 3. cyclophosphamide & prednisone without VTE
Only immediately reportable Serious Adverse Events (SAE) \& Venous thrombolytic event (VTE) were captured for the purpose of this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place