Trial Outcomes & Findings for Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy (NCT NCT01676961)
NCT ID: NCT01676961
Last Updated: 2018-10-15
Results Overview
Response is defined as platelet increases to greater than 50 x 10\^9/L for more than 2 weeks.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
8 weeks
Results posted on
2018-10-15
Participant Flow
Participant milestones
| Measure |
Supportive Care (Romiplostim)
Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count \> 50 x 10\^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..
romiplostim: Given SC
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Supportive Care (Romiplostim)
Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count \> 50 x 10\^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..
romiplostim: Given SC
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
Supportive Care (Romiplostim)
n=5 Participants
Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count \> 50 x 10\^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..
romiplostim: Given SC
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Data was not analyzed. Dr. Mazumder left institution and data was not analyzed.
Response is defined as platelet increases to greater than 50 x 10\^9/L for more than 2 weeks.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1.5 yearsPopulation: Patient data was not analyzefd
Outcome measures
Outcome data not reported
Adverse Events
Supportive Care (Romiplostim)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place