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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Dexamethasone; Drug: Cyclophosphamide; Drug: Bortezomib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00833560

2005-003902-27 (EudraCT Number)

CR005242

26866138MMY2031 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 401 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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401 participants in 1 patient group

Cyclophosphamide + Bortezomib + Dexamethasone

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

Drug: Bortezomib

Drug: Cyclophosphamide