Completed

VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma

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What is being tested

VELCADE and rituximab

Drug
Who is being recruted

B-Cell Lymphoma

+ Follicular Lymphoma
+ Marginal Lymphoma
Over 18 Years
+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2004

See protocol details

Summary

Principal SponsorMillennium Pharmaceuticals, Inc.
Last updated: February 11, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.

Official TitleA Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma 
Principal SponsorMillennium Pharmaceuticals, Inc.
Last updated: February 11, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
66 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
B-Cell Lymphoma
Follicular Lymphoma
Marginal Lymphoma
Criteria
8 inclusion criteria required to participate
Male or female subject 18 years or older
Diagnosis of B-cell lymphoma (CD20+) of
follicular lymphoma (grades 1, 2, and 3) or
marginal zone lymphoma (extranodal, nodal, and splenic)

Show More Criteria

16 exclusion criteria prevent from participating
Previous treatment with VELCADE
Any anti-neoplastic or experimental therapy within 3 weeks before the first dose of study drug
Any treatment with nitrosoureas within 6 weeks before the first dose of study drug
Treatment with Zevalin™ or Bexxar® within 10 weeks before the first dose of study drug

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 13 locations
Suspended
UCLA School of MedicineLos Angeles, United StatesSee the location
Suspended
Florida Cancer SpecialistsFort Myers, United States
Suspended
Emory University Cancer Institute, Winship Cancer InstituteAtlanta, United States
Suspended
Georgia Cancer SpecialistsMarietta, United States
Completed13 Study Centers