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

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

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

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 weeks

Population: 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 years

Population: 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

Amitabha Mazumder, MD

NYU Clinical Cancer Center

Phone: (212) 731-5757

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place