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NCT01720043 · REGISTRY CONDITION SEARCH

Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients

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

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-09-05

To evaluate the effect of VELCADE on platelet aggregation at baseline, 24 hours and 48 hours after infusion in patients with multiple myeloma

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

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baseline

Baseline characteristics

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outcome · POSTED

Efficacy of Velcade

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patients with the diagnosis of multiple myeloma * Patients should have not have received VELCADE for at least 2 weeks before receiving treatment with VELCADE for platelet aggregation testing * Patients are to be instructed not to take aspirin or ibuprofen 7-10 days prior to the platelet aggregations testing. * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of VELCADE, or agree to completely abstain from heterosexual intercourse. * Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse. Exclusion Criteria: * Patients who have received Velcade within 2 weeks prior to study registration * Patient has a platelet count of \< 150,000 within 7 days before enrollment. * Patient has an absolute neutrophil count of \< 1000 within 7 days before enrollment. * Patient has \> 1.5 x ULN Total Bilirubin * Patient has \> Grade 2 peripheral neuropathy * Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant. * Currently receiving medication with Coumadin, heparin, low molecular weight heparin, or NSAIDS. Concomitant use with any of these medications must be discontinued within two weeks prior to beginning protocol treatment. * Patient has hypersensitivity to VELCADE, boron, or mannitol. * Female subject is pregnant or lactating. Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women. * Female patients who are lactating or have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on Day 1 before first dose of study drug, if applicable. * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. * Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial. * Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    All participants enrolled
    intervention Names
    1. Drug: Velcade
    label
    All participants
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. All participants
    description
    Single dose of Velcade (1.0-1.3 mg/m2 dose)
    name
    Velcade
    other Names
    1. Bortezomib
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
8
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.
    measure
    Efficacy of Velcade
    time Frame
    48 hours
Full study description
brief Summary
To evaluate the effect of VELCADE on platelet aggregation at baseline, 24 hours and 48 hours after infusion in patients with multiple myeloma
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      requested nct id
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      primary nct id
      NCT01720043
      source kind
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      source record id
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      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
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      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-c34bce09a8a261055d4f
      link basis
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      nct id
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      occurrences
      1. context exact
        NCT01720043
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        11
        exact text
        NCT01720043
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      35f187f1f8bf33e7e7ffb183500b5bfa299e6c414221fb0a8cf30e8e92a9a621

    Preserved source evidence · Not medical advice