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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier:
NCT00833560
First received: January 23, 2009
Last updated: January 15, 2014
Last verified: January 2014

January 23, 2009
January 15, 2014
March 2006
June 2009   (final data collection date for primary outcome measure)
Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set) [ Time Frame: Up to Day 63 ] [ Designated as safety issue: No ]
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.
Efficacy of an induction therapy with Bortezomib in combination with Cyclophosphamide and Dexamethasone (Combined complete and partial response assessed by EBMT criteria (Bladé 1998))
Complete list of historical versions of study NCT00833560 on ClinicalTrials.gov Archive Site
  • Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set) [ Time Frame: Up to Day 63 ] [ Designated as safety issue: No ]
    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 (CR) + Partial Response (PR) in Relation to Cytogenetic Subgroups (Efficacy Set) [ Time Frame: Up to Day 63 ] [ Designated as safety issue: No ]
    Percentage of participants who has achieved CR + PR in relation to cytogenetic changes ie, who had experienced specific cytogenetic changes is reported. According to European Group for Blood and Marrow Transplantation 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. Bone marrow evaluation was done for the assessment of cytogenetic response.
  • Percentage of Participants With Complete Response (CR) + Partial Response (PR) in Relation to Cytogenetic Subgroups (Per-protocol Set) [ Time Frame: Up to Day 63 ] [ Designated as safety issue: No ]
    Percentage of participants who has achieved CR + PR in relation to cytogenetic changes ie, who had experienced specific cytogenetic changes is reported. According to European Group for Blood and Marrow Transplantation 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. Bone marrow evaluation was done for the assessment of cytogenetic response.
Tolerability and comparison of response rates in different cytogenetic risk groups
Not Provided
Not Provided
 
A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy
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; DSMM XIa)

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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: 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.
  • 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).
    Other Name: VELCADE
  • 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).
Experimental: 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.
Interventions:
  • Drug: Cyclophosphamide
  • Drug: Bortezomib
  • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
401
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00833560
CR005242, 26866138MMY2031, 2005-003902-27
No
Janssen-Cilag G.m.b.H
Janssen-Cilag G.m.b.H
Not Provided
Study Director: Janssen-Cilag G.m.b.H, Germany Clinical Trial Janssen-Cilag G.m.b.H
Janssen-Cilag G.m.b.H
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP