NCT00569868 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2011-08-12

To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma.

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Patients with myeloma who had relapsed after one prior treatment and who have demonstrated resistance to their last treatment, who are candidate to receive Velcade and had normal PT and PTT, will be evaluated for inclusion in the present study. Exclusion Criteria: * Previous history of venous thromboembolism, myocardial infarction, stroke, TIA * Hypercoagulable state (deficit ATIII, Factor V Leiden, deficit protein S, deficit protein C, prothrombin gene mutation), antiphospholipid syndrome. * Von Willebrand disease, inherited platelet abnormalities. * Familiar history of hypercoagulable state. * Anticoagulant therapy, aspirin, non-steroidal anti-inflammatory drugs, beta blockers, tricyclic antidepressant, hormone replacement therapy, BCPs, and all other agents able to interfere with platelet function in the previous two weeks. * Non-secretory MM, unless the patient has measurable lesions on CT, MRI and/or PET.
healthy Volunteers: true
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days. After you have gone off study, you will be followed every three months for approximately 2 years. Each cycle will consist of 3 weeks (21 days) according to the schedule below. DRUG ROUTE DOSE DAYS Velcade IV 1.3 mg/m2 1,4,8, and 11 This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a two cycles.
intervention Names
Drug: Velcade
label
Velcade
type
EXPERIMENTAL

interventions

arm Group Labels
Velcade
description
Except for the two PCR-based genotyping assays, which will be conducted only on baseline samples, tests will be assessed at baseline, 1-3 hours after the first dose of Velcade day 1 and on day 11 of the first cycle of Velcade. The platelet Aggregation Test will be done only if Platelet count is 100 000.
name
Velcade
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

Enrollment

count: 11
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma.
time Frame
60 days

Full study description

brief Summary: To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.
detailed Description: Cardiovascular complications during the treatment of patients with multiple myeloma are not uncommon, (10%) and the frequency clearly increases with the use of regimens containing thalidomide in combination with glucocorticosteroids or chemotherapy especially adriamycin. Even with prophylactic anticoagulation, DVT still occurs in 10% of such patients. The use of full anticoagulation raises considerable concern of bleeding especially during the post chemotherapy thrombocytopenic period. We observed no thromboembolic episodes when Velcade was added to thalidomide and adriamycin containing chemotherapy. Therefore, we would like to investigate this protective antithrombotic effect of VELCADE in a malignancy associated with a hypercoagulable state in a group of 10 patients with Relapsed/Refractory Multiple Myeloma.

Source references

references

citation
Zangari M, Yaccoby S, Pappas L, Cavallo F, Kumar NS, Ranganathan S, Suva LJ, Gruenwald JM, Kern S, Zhan F, Esseltine D, Tricot G. A prospective evaluation of the biochemical, metabolic, hormonal and structural bone changes associated with bortezomib response in multiple myeloma patients. Haematologica. 2011 Feb;96(2):333-6. doi: 10.3324/haematol.2010.031302. Epub 2010 Oct 15.
pmid
20952514
type
DERIVED