VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Millennium Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Mantle Cell Lymphoma

Treatments

Drug: VELCADE TM (bortezomib) for Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00063713

M34103-053

Details and patient eligibility

About

The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse.

Full description

VELCADE is approved in multiple myeloma for patients who have received two prior therapies and their disease came back or got worse while on their second therapy. VELCADE is currently being studied in other types of cancers.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

18 years of age or older
Confirmed diagnosis of mantle cell lymphoma
Documented relapse or progressive disease following 1 or 2 prior lines of anti-cancer therapy. At least one of those regimens must have included an anthracycline or mitoxantrone. Relapsed or progressive disease, since last therapy must be documented by new lesions or objective evidence of the progression of existing lesions.
At least 1 measurable or evaluable site of disease
Voluntary consent

Exclusion Criteria

Previous treatment with VELCADE
Any experimental or anti-cancer therapy within 3 weeks before the first dose of study drug
Radiation therapy within 3 weeks before the first dose of study drug
Major surgery with 2 weeks before the first dose of study drug
Rituximab, Campath, or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug
Radioimmunotherapy or other toxin immunoconjugates such as Zevalin or Bexxar within 10 weeks before the first dose of study drug
History of allergic reactions to boron or mannitol compounds
Diagnosed or treated for another malignancy other than mantle cell lymphoma with 5 years before the first dose of study drug
Active systemic infection requiring treatment
Women patients must not be pregnant or breast-feeding, confirmed through pregnancy test obtained during screening (this test is not required for women who are post-menopausal or surgically sterile)
Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Concurrent treatment with another investigational drug or participation in non-treatment studies is not allowed if it interferes with participation in this clinical study