Multiple Myeloma
Conditions
Keywords
multiple myeloma
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
Interventions
DRUGVelcade
Single dose of Velcade (1.0-1.3 mg/m2 dose)
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Velcade | 48 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants enrolled
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose) | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Efficacy of Velcade
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.
Time frame: 48 hours
Population: One patient withdrew before receiving the 24 hour dose, leaving 7 patients evaluable for response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Efficacy of Velcade | ADP.10.M, 48 hrs | -3.429 percentage | Standard Deviation 7.044 |
| All Participants | Efficacy of Velcade | Collagen 5.g.ml, 24 hrs | -4.143 percentage | Standard Deviation 7.244 |
| All Participants | Efficacy of Velcade | Collagen 2.g.ml, 24 hrs | -4.429 percentage | Standard Deviation 7.39 |
| All Participants | Efficacy of Velcade | ADP.10.M, 24 hrs | -4.571 percentage | Standard Deviation 6.949 |
| All Participants | Efficacy of Velcade | ADP.5.M, 24 hrs | -6.429 percentage | Standard Deviation 7.591 |
| All Participants | Efficacy of Velcade | ADP.3.M, 24 hrs | -7.571 percentage | Standard Deviation 16.4 |
| All Participants | Efficacy of Velcade | Arach.Acid.0.5.mg.ml, 24 hrs | -11.143 percentage | Standard Deviation 15.507 |
| All Participants | Efficacy of Velcade | Ristocetin1.5.mg.ml, 24 hrs | -1.429 percentage | Standard Deviation 7.345 |
| All Participants | Efficacy of Velcade | Ristocetin.0.5.mg.ml, 24 hrs | -2.429 percentage | Standard Deviation 6.803 |
| All Participants | Efficacy of Velcade | Collagen.5.g.mL, 48 hrs | -2.429 percentage | Standard Deviation 10.13 |
| All Participants | Efficacy of Velcade | Collagen.2.g.mL, 48 hrs | -0.857 percentage | Standard Deviation 10.605 |
| All Participants | Efficacy of Velcade | ADP.5.M, 48 hrs | -3.571 percentage | Standard Deviation 10.845 |
| All Participants | Efficacy of Velcade | ADP.3.M, 48 hrs | 1.571 percentage | Standard Deviation 13.587 |
| All Participants | Efficacy of Velcade | Arach.Acid.0.5.mg.mL, 48 hrs | -2.286 percentage | Standard Deviation 11.368 |
| All Participants | Efficacy of Velcade | Ristocetin.1.5.mg.mL, 48 hrs | .0143 percentage | Standard Deviation 9.353 |
| All Participants | Efficacy of Velcade | Ristocetin.0.5.mg.mL, 48 hrs | -2.000 percentage | Standard Deviation 4.041 |
Comparison: Collagen.5.g.ml, 24 hrsp-value: 0.181t-test, 2 sided
Comparison: Collagen.2.g.mlp-value: 0.164t-test, 2 sided
Comparison: ADP.10.M, 24 hrsp-value: 0.132t-test, 2 sided
Comparison: ADP.5.Mp-value: 0.066t-test, 2 sided
Comparison: ADP.3.M, 24 hrsp-value: 0.268t-test, 2 sided
Comparison: Arach.Acid.0.5.mg.mlp-value: 0.106t-test, 2 sided
Comparison: Ristocetin.1.5.mg.mlp-value: 0.625t-test, 2 sided
Comparison: Ristocetin.0.5.mg.mlp-value: 0.381t-test, 2 sided
Comparison: Collagen.5.g.ml, 48 hrsp-value: 0.549t-test, 2 sided
Comparison: Collagen.2.g.ml, 48 hrsp-value: 0.838t-test, 2 sided
Comparison: ADP.10.Mp-value: 0.245t-test, 2 sided
Comparison: ADP.5.Mp-value: 0.417t-test, 2 sided
Comparison: ADP.3.M, 48 hrsp-value: 0.77t-test, 2 sided
Comparison: Arach.Acid.0.5.mg.ml, 48 hrsp-value: 0.614t-test, 2 sided
Comparison: Ristochetin.1.5.mg.mlp-value: 0.969t-test, 2 sided
Comparison: Ristocetin.0.5.mg.ml, 48 hrsp-value: 0.238t-test, 2 sided