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International Single-Arm Protocol to Provide Expanded Access to Bortezomib for Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma


N/A
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

International Single-Arm Protocol to Provide Expanded Access to Bortezomib for Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma


Multiple myeloma is uniformly fatal. Responses achieved after multiple lines of therapy are
normally of short duration. Therefore, all patients with multiple myeloma will eventually
relapse, having become refractory to therapy and subsequently will die of their cancer. The
rationale of this study is that bortezomib as a novel agent may allow additional periods of
response due to its different mechanisms of action. This is an open-label, single-arm,
multicenter, non-comparative study to provide expanded access to bortezomib to patients with
multiple myeloma that have received at least two previous lines of therapy and are
refractory to or have relapsed after their last treatment. Patients will receive treatment
with bortezomib 1.3 mg/m2 on day 1, 4, 8 and 11 of a 3-week cycle. No treatment will be
administered on the last 10 days of each cycle. Treatment may be repeated for up to 8 cycles
with possible extension if patient is still responding at the end of the 8 cycle period.
Bortezomib 1.3 mg/m2 will be administered as an IV bolus


Inclusion Criteria:



- Patients with previous diagnosis of multiple myeloma based on standard criteria

- patient has received at least 2 previous lines of therapy for multiple myeloma and,
currently requires therapy because of relapsed or progressive disease

- If female, the patient is either postmenopausal or surgically sterilized or willing
to use an acceptable method of birth control (i.e., a hormonal contraceptive,
intrauterine device, diaphragm with spermicide, or condom with spermicide, or
abstinence) from Screening through the Final Visit

- If male, the patient agrees to use an acceptable barrier method for contraception
from Screening through the Final Visit

- patient has a Karnofsky performance status >= 60

- patient meets defined pretreatment laboratory criteria

Exclusion Criteria:

- If patient received bortezomib in a previous clinical trial, the patient's best
response to bortezomib was progressive disease

- Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks
before enrollment, corticosteroids (>10 mg/day prednisone or equivalent) within 3
weeks before enrollment, immunotherapy or antibody therapy within 4 weeks before
enrollment

- Patient has peripheral neuropathy of Grade 2 or greater intensity, as defined by the
NCI CTC

- Patient had a myocardial infarction within 6 months of 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

- Patient has cardiac amyloidosis

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Janssen-Cilag International NV Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag International NV

Authority:

Belgium: Ministry of Social Affairs, Public Health and the Environment

Study ID:

CR002185

NCT ID:

NCT00440635

Start Date:

January 2004

Completion Date:

October 2006

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • bortezomib, Hematology
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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