Trial Outcomes & Findings for Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma (NCT NCT01484314)

NCT ID: NCT01484314

Last Updated: 2017-03-15

Results Overview

To determine the proportion of patients with relapsed multiple myeloma in whom eltrombopag maintains platelet counts at \> 90% of baseline platelet counts with no more than 4 units of platelet transfusions at day 1 of Cycle 3 of chemotherapy

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

2 years

Results posted on

2017-03-15

Participant Flow

Participant milestones

Participant milestones
Measure
Migration Arm
Administration of eltrombopag to support platelets during chemotherapy Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy
Overall Study
STARTED
1
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Terminated with 1 patient enrolled; no data due to patient privacy.

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 2 years

Population: Terminated with 1 patient enrolled; no data due to patient privacy.

To determine the proportion of patients with relapsed multiple myeloma in whom eltrombopag maintains platelet counts at \> 90% of baseline platelet counts with no more than 4 units of platelet transfusions at day 1 of Cycle 3 of chemotherapy

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 years

Population: Terminated with 1 patient enrolled; no data due to patient privacy.

To determine whether eltrombopag administration results in an increased number of participants with adverse events.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Terminated with 1 patient enrolled; no data due to patient privacy.

To assess whether eltrombopag decreases the incidence of grade 3/4 thrombocytopenic events by day 1 of Cycle 3 of chemotherapy

Outcome measures

Outcome data not reported

Adverse Events

Migration Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nancy Berliner

Brigham and Womens Hospital/ Dana Farber Cancer Institute

Phone: 617-732-5840

Results disclosure agreements

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