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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cyclophosphamide
Bortezomib
Dexamethasone
Sponsored by
Janssen-Cilag G.m.b.H
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Untreated multiple myeloma, Bortezomib, VELCADE, Cyclophosphamide, Dexamethasone, Chemotherapy, Remission therapy, Induction therapy, Stem Cell Transplantation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyclophosphamide + Bortezomib + Dexamethasone

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis 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.
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)
Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)
Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible.

Full Information

First Posted
January 23, 2009
Last Updated
November 11, 2014
Sponsor
Janssen-Cilag G.m.b.H
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1. Study Identification

Unique Protocol Identification Number
NCT00833560
Brief Title
A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy
Official Title
Clinical Study on Induction of Remission Using Bortezomib (Vel), Cyclophosphamide (C), and Dexamethasone (D) in Patients Until 60 Years of Age With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy: (VelCD; Deutsche Studiengruppe Multiples Myelom [DSMM] XIa)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag G.m.b.H

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Untreated multiple myeloma, Bortezomib, VELCADE, Cyclophosphamide, Dexamethasone, Chemotherapy, Remission therapy, Induction therapy, Stem Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclophosphamide + Bortezomib + Dexamethasone
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
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
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
VELCADE
Intervention Description
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
Intervention Name(s)
Dexamethasone
Intervention Description
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).
Primary Outcome Measure Information:
Title
Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)
Description
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.
Time Frame
Up to Day 63
Secondary Outcome Measure Information:
Title
Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)
Description
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.
Time Frame
Up to Day 63
Title
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)
Description
Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible
Time Frame
Up to Day 63
Title
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)
Description
Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible.
Time Frame
Up to Day 63

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag G.m.b.H, Germany Clinical Trial
Organizational Affiliation
Janssen-Cilag G.m.b.H
Official's Role
Study Director
Facility Information:
City
Berg
Country
Germany
City
Berlin
Country
Germany
City
Bremen
Country
Germany
City
Dresden
Country
Germany
City
Erlangen
Country
Germany
City
Frankfurt / Main
Country
Germany
City
Freiburg
Country
Germany
City
Greifswald
Country
Germany
City
Göttingen
Country
Germany
City
Halle
Country
Germany
City
Hamburg
Country
Germany
City
Hamm
Country
Germany
City
Hannover
Country
Germany
City
Homburg
Country
Germany
City
Jena
Country
Germany
City
Karlsruhe
Country
Germany
City
Kiel
Country
Germany
City
Lübeck
Country
Germany
City
Magdeburg
Country
Germany
City
Mainz
Country
Germany
City
Muenchen
Country
Germany
City
Mutlangen
Country
Germany
City
München
Country
Germany
City
Münster
Country
Germany
City
Nürnberg
Country
Germany
City
Oldenburg
Country
Germany
City
Potsdam
Country
Germany
City
Regensburg
Country
Germany
City
Rehling
Country
Germany
City
Rostock
Country
Germany
City
Stuttgart
Country
Germany
City
Tübingen
Country
Germany
City
Ulm
Country
Germany
City
Villingen-Schwenningen
Country
Germany
City
Würzburg
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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