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

NCT00833560 | Completed Phase 2 Results

• 3 other identifiers: CR00524226866138MMY20312005-003902-27
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 34

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Untreated multiple myeloma; Bortezomib; VELCADE; Cyclophosphamide; Dexamethasone; Chemotherapy; Remission therapy; Induction therapy; Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)

  CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.

  Up to Day 63

Secondary Outcomes (3)

• Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)

  Up to Day 63

• Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)

  Up to Day 63

• Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)

  Up to Day 63

Study Arms (1)

Cyclophosphamide + Bortezomib + Dexamethasone

EXPERIMENTAL

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.

Drug: Cyclophosphamide; Drug: Bortezomib; Drug: Dexamethasone

Interventions

Cyclophosphamide 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.

Cyclophosphamide + Bortezomib + Dexamethasone

Bortezomib 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).

Also known as: VELCADE

Cyclophosphamide + Bortezomib + Dexamethasone

Dexamethasone 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).

Cyclophosphamide + Bortezomib + Dexamethasone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag G.m.b.H: lead

Study Sites (34)

Unknown Facility

Berg, Germany

Location

Unknown Facility

Berlin, Germany

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Bremen, Germany

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Dresden, Germany

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Erlangen, Germany

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Frankfurt am Main, Germany

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Freiburg im Breisgau, Germany

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Göttingen, Germany

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Greifswald, Germany

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Halle, Germany

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Hamburg, Germany

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Hamm, Germany

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Hanover, Germany

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Homburg, Germany

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Jena, Germany

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Karlsruhe, Germany

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Kiel, Germany

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Lübeck, Germany

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Magdeburg, Germany

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Mainz, Germany

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Mutlangen, Germany

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München, Germany

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Münster, Germany

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Nuremberg, Germany

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Oldenburg, Germany

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Potsdam, Germany

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Regensburg, Germany

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Rehling, Germany

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Rostock, Germany

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Stuttgart, Germany

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Tübingen, Germany

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Unknown Facility

Ulm, Germany

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Unknown Facility

Villingen-Schwenningen, Germany

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Unknown Facility

Würzburg, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Cyclophosphamide; Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Therapeutic Areas Director
• Organization: Jan-Cil Germany

+49 2137 955-492

Study Officials

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

  Janssen-Cilag G.m.b.H

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: February 2, 2009
• Study Start: March 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 21, 2014
• Results First Posted: March 3, 2014

Record last verified: 2014-11

Locations

DE (34)