Trial Outcomes & Findings for UARK 2005-05, Coagulation-Related Effects of Velcade Treatment in Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT00569868)

Results Overview

Goal is to evaluate changes in coagulation (blood clotting) in refractory/relapsing multiple myeloma patients during VELCADE treatment. Before and during treatment, participant will undergo routine tests/procedures following the Myeloma Institute's guidelines (physical exams, blood, urine, and bone tests, and bone marrow aspirates and biopsies) and will also receive a series of coagulation tests before treatment and after 1st and 3rd doses of each cycle. Response measured as: complete, partial, or minimal response, no change, progressive disease, or relapse from complete response.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

60 days

Results posted on

2011-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Velcade Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

UARK 2005-05, Coagulation-Related Effects of Velcade Treatment in Patients With Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Velcade n=11 Participants Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age Continuous	64 years STANDARD_DEVIATION 7.67 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days

Population: no analysis done, descriptive information on the magnitude, direction, and variability of changes in coagulation factors and platelet function in refractory/relapsing multiple myeloma patients during VELCADE treatment was collected

Goal is to evaluate changes in coagulation (blood clotting) in refractory/relapsing multiple myeloma patients during VELCADE treatment. Before and during treatment, participant will undergo routine tests/procedures following the Myeloma Institute's guidelines (physical exams, blood, urine, and bone tests, and bone marrow aspirates and biopsies) and will also receive a series of coagulation tests before treatment and after 1st and 3rd doses of each cycle. Response measured as: complete, partial, or minimal response, no change, progressive disease, or relapse from complete response.

Outcome measures

Outcome data not reported

Adverse Events

Velcade

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

Nathan M. Petty

University of Arkansas for Medical Sciences, Myeloma Institute

Phone: 5015266990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place