Know Cancer

or
forgot password

Comparison of Pharmacokinetics and Pharmacodynamics of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma


Phase 1
N/A
75 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

Comparison of Pharmacokinetics and Pharmacodynamics of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma


Inclusion Criteria:



- diagnosis of MM according to the SWOG criteria (annex I)

- symptomatic MM stage II or III according to Durie-Salmon staging system (annex II) or
stage I with one symptomatic osteolytic lesion

- with progressive disease after at least one prior therapy and who have already
undergone or are unsuitable for bone marrow transplantation

- with measurable levels of paraprotein in the serum (> 1g/dl) or in the urine (>
0.2g/24h)

- age < 75 years

- able to understand and to given an informed consent

- male, female without childbearing potential or negative urine pregnancy test within
72 hours prior to beginning the treatment. Women of childbearing potential must be
following adequate contraceptive measures. Men must agree to use an acceptable method
of contraception (for themselves or female partners) for the duration of the study

- no active systemic infection. In the presence of any active systemic infection,
adequate broad-spectrum or organism-specific antibiotic coverage must be
administered. Patients must be afebrile with stable vital signs while receiving
antibiotics for at least 48 hours prior to beginning the treatment with Bortezomib.

- Each subject will weigh ³50 kg and have a body mass index (BMI) of £30 kg/m2 (see
annex V for BMI formula).

Exclusion Criteria:

- life expectancy < 2 months

- ECOG performance status > 2 (annex III)

- proven amyloidosis

- positive HIV serology

- antecedents of severe psychiatric disease

- > NCI grade 2 peripheral neuropathy (Annex IV)

- History of clinically relevant cardiac disease, including prior myocardial
infarction, prior or existing heart failure, existing uncontrolled angina or
clinically significant pericardial disease Evidence of arrhythmia, 2nd degree or
greater AV block or prolonged QTc interval (>0.45 seconds in males, >0.47 seconds in
females) on screening ECG

- serum biochemical values as follow

- creatinine level > 200mmol/l

- bilirubin, transaminases or gGT > 3 the upper normal limit

- potassium, calcium or magnesium outside of upper or lower normal limits

- haematology values as follow

- platelet < 70x 109 /L within 14 days of enrollment

- absolute neutrophil count <1.0 x 109/L within 14 days of enrolment

- concomitant use of drugs able to modify QTc interval within 1 week prior to the first
dose of bortezomib and during Cycle 1 (Annex VI)

- concomitant use of potent inhibitors or inducers of the cytochrome P450 (CYP) enzymes
3A and 2C19 within 1 week prior to the first dose of bortezomib and during Cycle 1
(see annex VII list of representative drugs).

- use of any experimental drugs within 30 days of baseline

- hypersensitivity to bortezomib, boron, or mannitol

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

characterize the pharmacokinetics of the 2 routes of administration.

Principal Investigator

Jean-Luc HAROUSSEAU, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nantes UH

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD/05/9-B

NCT ID:

NCT00291538

Start Date:

February 2006

Completion Date:

October 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location