Trial Outcomes & Findings for A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma (NCT NCT00283439)

NCT ID: NCT00283439

Last Updated: 2011-06-20

Results Overview

Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

39 participants

Primary outcome timeframe

32 weeks

Results posted on

2011-06-20

Participant Flow

Participants were enrolled from 15 March 2006 through 28 April 2008

Participant milestones

Participant milestones
Measure	Romiplostim 100 µg Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 300 µg Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 700 µg Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 1000 µg Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Overall Study STARTED	8	11	11	9
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	8	11	11	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Romiplostim 100 µg Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 300 µg Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 700 µg Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 1000 µg Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Overall Study Adverse Event	0	0	0	1
Overall Study Death	0	0	1	0
Overall Study Disease progression	0	1	0	0
Overall Study Requirement for alternative therapy	1	2	5	2
Overall Study Stem cell transplant	6	6	4	3
Overall Study Treatment discontinued	0	2	1	3
Overall Study Other	1	0	0	0

Baseline Characteristics

A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Romiplostim 100 µg n=8 Participants Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 300 µg n=11 Participants Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 700 µg n=11 Participants Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 1000 µg n=9 Participants Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy	Total n=39 Participants Total of all reporting groups
Age Continuous	61.3 Year STANDARD_DEVIATION 6.2 • n=5 Participants	58.1 Year STANDARD_DEVIATION 9.5 • n=7 Participants	54.0 Year STANDARD_DEVIATION 16.3 • n=5 Participants	59.9 Year STANDARD_DEVIATION 10.6 • n=4 Participants	58.0 Year STANDARD_DEVIATION 11.5 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	15 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	24 Participants n=21 Participants
Race/Ethnicity, Customized White or Caucasian	6 Participant n=5 Participants	10 Participant n=7 Participants	10 Participant n=5 Participants	8 Participant n=4 Participants	34 Participant n=21 Participants
Race/Ethnicity, Customized Black or African American	0 Participant n=5 Participants	0 Participant n=7 Participants	1 Participant n=5 Participants	1 Participant n=4 Participants	2 Participant n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participant n=5 Participants	1 Participant n=7 Participants	0 Participant n=5 Participants	0 Participant n=4 Participants	3 Participant n=21 Participants

PRIMARY outcome

Timeframe: 32 weeks

Population: Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.

Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.

Outcome measures

Outcome measures
Measure	Romiplostim 100 µg n=8 Participants Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 300 µg n=11 Participants Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 700 µg n=10 Participants Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 1000 µg n=9 Participants Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Change in Platelet Nadir	17.1 10^9/L Standard Error 8.3	11.2 10^9/L Standard Error 6.1	5.1 10^9/L Standard Error 6.1	-5.2 10^9/L Standard Error 7.8

SECONDARY outcome

Timeframe: 32 weeks

Population: Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.

Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L, and \<25 x 10\^9/L)

Outcome measures

Outcome measures
Measure	Romiplostim 100 µg n=8 Participants Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 300 µg n=11 Participants Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 700 µg n=10 Participants Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 1000 µg n=9 Participants Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia	62.5 Percentage of participants	81.8 Percentage of participants	80.0 Percentage of participants	88.9 Percentage of participants

SECONDARY outcome

Timeframe: 32 weeks

Population: Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.

Duration of grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L and \<25 x 10\^9/L, respectively)

Outcome measures

Outcome measures
Measure	Romiplostim 100 µg n=8 Participants Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 300 µg n=11 Participants Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 700 µg n=10 Participants Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 1000 µg n=9 Participants Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Duration of Grade 3 or 4 Thrombocytopenia	3.9 Day Standard Error 1.3	3.6 Day Standard Error 0.9	6.0 Day Standard Error 1.5	8.3 Day Standard Error 2.1

SECONDARY outcome

Timeframe: 32 weeks

Population: Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.

Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle

Outcome measures

Outcome measures
Measure	Romiplostim 100 µg n=8 Participants Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 300 µg n=11 Participants Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 700 µg n=10 Participants Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy	Romiplostim 1000 µg n=9 Participants Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Percentage of Subjects That Received Platelet Transfusions	12.5 Percentage of participants	0.0 Percentage of participants	30.0 Percentage of participants	33.3 Percentage of participants

Adverse Events

Romiplostim 100 µg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Romiplostim 300 µg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Romiplostim 700 µg

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Romiplostim 1000 µg

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Romiplostim 100 µg n=8 participants at risk	Romiplostim 300 µg n=11 participants at risk	Romiplostim 700 µg n=11 participants at risk	Romiplostim 1000 µg n=9 participants at risk
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.2% 2/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 1/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Mucosal inflammation	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 1/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bacteraemia	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 1/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Clostridium difficile colitis	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 1/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Device related infection	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Staphylococcal infection	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 1/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 1/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Convulsion	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure acute	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 1/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 1/9 • From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER