A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy

NCT ID: NCT00833560

Last Updated: 2014-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-06-30

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of bortezomib in combination with a standard regimen of cyclophosphamide and dexamethasone.

Detailed Description

This is open-label (both the participant and the investigator know what treatment participants will receive), prospective (participants are identified and then followed forward in time for the outcome of the study), multi-centre, and non-randomized (participants are assigned to different treatment groups by the investigator) study. The study will be conducted into 2 parts (Part 1 and Part 2). Approximately 400 participants will be enrolled (30 in Part 1 and 370 in Part 2). In Part 1 the optimum dose of cyclophosphamide will be evaluated and in Part 2 the selected dose of cyclophosphamide from Part 1 will be administered. Part 2 will include a screening period of a maximum of 14 days followed by chemotherapy (bortezomib, cyclophosphamide, and dexamethasone) of a maximum of three 21-day cycles. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, electrocardiogram, and clinical laboratory tests which will be monitored throughout the study.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyclophosphamide + Bortezomib + Dexamethasone

Part 1 will be the dose titration part for cyclophosphamide. Participants will receive cyclophosphamide, bortezomib, and dexamethasone for 3 cycles. In Part 2, participants will receive cyclophosphamide (dose determined in Part 1) with pre-defined dose of bortezomib and dexamethasone for 3 cycles.

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

In Part 1, cyclophosphamide with dose ranging from 900 to 1500 mg will be administered intravenously on Day 1 of each 21 day cycle for 3 cycles to determine optimal dose. In Part 2, optimal dose determined in Part 1 will be administered on Day 1 of each 21 day cycle for 3 cycles.

Bortezomib

Intervention Type: DRUG

Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1,4,8, and 11 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).

Dexamethasone

Intervention Type: DRUG

Participants will receive dexamethasone 40 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).

Interventions

Cyclophosphamide

In Part 1, cyclophosphamide with dose ranging from 900 to 1500 mg will be administered intravenously on Day 1 of each 21 day cycle for 3 cycles to determine optimal dose. In Part 2, optimal dose determined in Part 1 will be administered on Day 1 of each 21 day cycle for 3 cycles.

Intervention Type: DRUG

Bortezomib

Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1,4,8, and 11 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).

Intervention Type: DRUG

Dexamethasone

Participants will receive dexamethasone 40 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).

Intervention Type: DRUG

Other Intervention Names

VELCADE

Eligibility Criteria

Inclusion Criteria

• Cytologically or histologically diagnosed with multiple myeloma stage II/III
• Participants without preceding cytostatic (tending to retard cellular activity and multiplication) treatment (pretreatment with radiation or dexamethasone is allowed)
• Agree to use one of the contraception methods as defined in the protocol
• Karnofsky performance status 60 percent or more
• Adequate laboratory test values

Exclusion Criteria

• Non-secretory multiple myeloma
• Estimated life expectancy less than 3 months
• History of cancer (except basal cell carcinoma) in the last 5 years
• Peripheral neuropathy (disorder of the peripheral nerves) grade 2 or more
• Positive human immunodeficiency virus test and active hepatitis B and/or hepatitis C
• Pregnant or breast-feeding female participants

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag G.m.b.H

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag G.m.b.H, Germany Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag G.m.b.H

Locations

Berg, , Germany

Berlin, , Germany

Bremen, , Germany

Dresden, , Germany

Erlangen, , Germany

Frankfurt am Main, , Germany

Freiburg im Breisgau, , Germany

Göttingen, , Germany

Greifswald, , Germany

Halle, , Germany

Hamburg, , Germany

Hamm, , Germany

Hanover, , Germany

Homburg, , Germany

Jena, , Germany

Karlsruhe, , Germany

Kiel, , Germany

Lübeck, , Germany

Magdeburg, , Germany

Mainz, , Germany

Mutlangen, , Germany

München, , Germany

Münster, , Germany

Nuremberg, , Germany

Oldenburg, , Germany

Potsdam, , Germany

Regensburg, , Germany

Rehling, , Germany

Rostock, , Germany

Stuttgart, , Germany

Tübingen, , Germany

Ulm, , Germany

Villingen-Schwenningen, , Germany

Würzburg, , Germany

Countries

Germany

Other Identifiers

26866138MMY2031

Identifier Type: OTHER

Identifier Source: secondary_id

2005-003902-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR005242

Identifier Type: -

Identifier Source: org_study_id