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Home > "R" Clinical Trials Conditions > Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients with Relapsed Multiple Myeloma  Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients with Relapsed Multiple Myeloma
Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients with Relapsed Multiple Myeloma
For Condition: Multiple Myeloma
Status: Recruiting
Sponsor(s): Millennium Pharmaceuticals ,
Synopsis: The purpose of this study is to characterize the clinical pharmacokinetic and pharmacodynamic profiles of the 2 doses of VELCADE (bortezomib) for Injection. Patients who volunteer to participate in the pharmacogenetic portion of the study, an additional blood sample will be collected before the Cycle 1 Day 1 dose of bortezomib to assess the genotype of drug metabolizing enzymes.
Details: This is a prospective, multicenter, open-label, randomized, single- and multiple-dose, clinical pharmacokinetic and pharmacodynamic study in which approximately 40 adult patients with relapsed multiple myeloma will be enrolled (to obtain 12 evaluable patients at each of 2 doses). Eligible patients will be randomized to 1 of 2 bortezomib doses: 1.0 mg/m2 (Treatment arm A) or 1.3 mg/m2 (Treatment arm B). Bortezomib dosing will occur on Days 1, 4, 8, and 11 followed by a 10-day rest period (21 day cycle). Pharmacokinetic and pharmacodynamic assessments will be completed during the first 3 cycles. Blood samples will be obtained at 0 (predose), 5, 15, and 30 minutes, and then 1, 2, 4, 6, 8, 12, 24, and 48 hours following the Day 1 and Day 11 doses of Cycles 1 and 3 to characterize the single- and multiple-dose plasma pharmacokinetics of bortezomib and to determine the extent and time course of 20S proteasome inhibition. A blood sample also will be obtained just before the dose on Days 4 and 8 (trough concentrations) during Cycles 1 and 3; on Days 15, 17, and 19 during the rest period of Cycles 1 and 3; and at predose on Day 1 of Cycles 2 and 4. Upon completion of the PK/PD assessment portion of the study (Cycles 1 through 3), the patient may continue treatment with bortezomib at the discretion of the investigator during Cycles 4 through 8. The duration of treatment in this study is a maximum of 8 cycles. Patients randomized to Treatment arm A (1.0 mg/m2) but not responding to therapy after 3 cycles can have the dose of bortezomib increased to 1.3 mg/m2 if no prohibitive toxicity occurred at the lower dose. The focus of this study is to characterize the clinical pharmacokinetic and pharmacodynamic profiles of the 2 doses of bortezomib. Only limited efficacy data (investigator’s assessment of response and quantitation of serum and urine M-protein, including immunofixation) will be collected. For patients who volunteer to participate in the pharmacogenetic portion of the study, an additional blood sample will be collected before the Cycle 1 Day 1 dose of bortezomib to assess the genotype of drug metabolizing enzymes. Patients will remain at the study site for 4 days (Days 1, 2, 11, and 12) of Cycles 1 and 3 for the intensive sampling, and will return as outpatients for the other days of dosing and sampling.
Eligibility:
Study Type: Interventional, Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Must be male and female patients 18 years old or older. - Must have relapsed multiple myeloma (diagnosed using standard criteria) following at least one line of prior chemotherapy and who require additional treatment. - Must have life expectancy equal or greater then 3 months. - Resolution of toxicities considered related to prior antineoplastic therapy. - Must have KPS equal or greater than 70%. - The following laboratory values at Screening must be: Aspartate transaminase (AST) equal or less than x upper limit of normal range (ULN); Alanine transaminase (ALT) equal or less than 2 x ULN; Total bilirubin equal or less than 1.5 x ULN; Hemoglobin equal or greater than 10 g/dL; (transfusion allowed to meet this criterion); Platelets equal or greater than 50 x 109/L; Absolute neutrophil count (ANC) equal or greater than 1000/uL; Calculated creatinine clearance equal or greater than 50 mL/min; Normal serum calcium (serum calcium, corrected for serum albumin, equal or less than ULN; 8.6-10.3 mg/dL or 2.15-2.58 mmol/L). - Female patient must be either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. - Male patient must agree to use an acceptable method for contraception for the duration of the study. - Must have 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 patient at any time without prejudice to future medical care. - Patients must be willing to remain in the hospital for PK/PD assessments. Exclusion Criteria: - Patient must not have a history of allergic reaction attributable to compounds containing boron or mannitol. - Patient can not have an active systemic infection requiring treatment. - Female patient can not be pregnant or breast-feeding. Confirmation that the patient is not pregnant must be established by a negative serum b-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during Screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women. - Significant cardiac disease, including a myocardial infarction within the previous 6 months. - Neuropathy is equal or greater then Grade 2. Transfusion-dependence (red blood cells and/or platelets). Patients who receive one transfusion before Cycle 1 Day 1 but are not transfusion-dependent may be enrolled. Transfusion-dependent is the term applied to patients who, on average, have received 4 to 6 transfusions of red cells and/or platelets within 6 months of the first dose of the planned study (i.e., equal or greater then 1 transfusion/month). - Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment. - Serious medical or psychiatric illness likely to interfere with participation in this clinical study. - Must not have active hepatitis, HIV disease, secondary malignancy, POEMS syndrome, or plasma cell leukemia. - Can not have concurrent treatment with another investigational agent within 4 weeks of enrollment. Concurrent participation in non-treatment studies is allowed, if such participation will not interfere with participation in this study.
Total Enrollment: 40
Location and Contact Information:
The Sarah Cannon Cancer Center *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting
Royal Victoria Hospital *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting
Princess Margaret Hospital/Toronto Research Inst. *Recruiting*
Toronto, Ontario, M5G2M9
Canada
Recruiting
University of Pittsburgh Medical Center *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting
Additional Information:
Study ID Numbers: M34103-058;
Study Start Date: March 2004
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080405
Other Multiple Myeloma Studies:
1. Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
2. Chemotherapy Plus Biological Therapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
3. Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
4. Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
5. T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients with Relapsed Multiple Myeloma
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