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An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)

Phase 1
18 Years
Not Enrolling
Multiple Myeloma, Non-Hodgkin's Lymphoma

Thank you

Trial Information

An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)

Inclusion Criteria:

- Male or female of at least 18 years of age.

- Has documented relapsed or refractory multiple myeloma or NHL following prior
anti-neoplastic treatment.

- Female patients must be post menopausal for at least 1 year (must not have had a
natural menses for at least 12 months), surgically sterile, abstinent, or, if
sexually active, be practicing an effective method of birth control (e.g.,
prescription oral contraceptives, contraceptive injections, intrauterine device,
double-barrier method, contraceptive patch, male partner sterilization) before entry
and throughout the study; have a negative serum β-HCG or a negative urine pregnancy
test at screening. (an alternative to oral contraceptives should be used if the
patient is randomized to Arm B with rifampicin).

- Male patients must agree to use an acceptable method of contraception (for themselves
or female partners as listed above) for the duration of the study.

- Must be able to swallow capsules/tablets whole (without chewing, crushing, or

- Agree to refrain from the use of any methylxanthine-containing products, including
caffeine (e.g., chocolate bars or beverages, coffee, teas, or colas), on Day 11 of
Cycles 2 and 3.

- Agree to refrain from the use of any products containing nicotine, alcohol, quinine,
grapefruit juice, or Seville oranges from 7 days before the first administration of
VELCADE through completion of the 72-hour PK blood sample collection (post Day 11
VELCADE dose) in Cycle 3.

Exclusion Criteria:

- Diagnosis or treatment of a malignancy other than multiple myeloma or NHL within 1
year of randomization, or who have previously been diagnosed with a malignancy other
than multiple myeloma or NHL and have any radiographic or biochemical marker evidence
of malignancy.

- History of clinically relevant liver or renal insufficiency; significant cardiac,
vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or
metabolic disturbances.

- Known or suspected hypersensitivity or intolerance to rifampicin and/or other
antibiotics, corticosteroids, boron or mannitol.

- Peripheral neuropathy or neuropathic pain Grade 2 or higher.

- Preplanned surgery or procedures that would interfere with the conduct of the study
or major surgery within 2 weeks before randomization.

- History of disallowed therapies:

- Prior treatment with VELCADE.

- Any drugs or agents that inhibit (e.g., cimetidine, erythromycin, fluoxetine,
ketoconazole, paroxetine) or induce (e.g., carbamazepine, glucocorticoids,
phenobarbital, phenytoin, St. John's Wort) CYP2C19 or CYP3A4 within 28 days
before the first administration of VELCADE.

- Any exposure to rifampicin or corticosteroids within 28 days of screening.

- Have received an investigational agent or used an investigational medical device
within 28 days before the planned start of treatment. Concurrent participation
in non-treatment studies is allowed, if it will not interfere with participation
in this study.

- Female patient who is pregnant or breastfeeding.

- Employees of the investigator or study center, with direct involvement in the
proposed study or other studies under the direction of that investigator or study
center, as well as family members of the employees or the investigator.

Type of Study:


Study Design:

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

Outcome Measure:

Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours

Outcome Time Frame:

Cycle 3 day 14 (72 hours post last dose)

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

April 2010

Related Keywords:

  • Multiple Myeloma
  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell