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: September 4, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: Cyclophosphamide
Drug: Bortezomib
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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; DSMM XIa)

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag G.m.b.H:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set) [ Time Frame: Up to Day 63 ] [ Designated as safety issue: No ]
    Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EMBT 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) [ Time Frame: Up to Day 63 ] [ Designated as safety issue: No ]
    Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EMBT 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.


Enrollment: 401
Study Start Date: March 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833560

Locations
Germany
Berg, Germany
Berlin, Germany
Bremen, Germany
Dresden, Germany
Erlangen, Germany
Frankfurt / Main, Germany
Freiburg, Germany
Greifswald, Germany
Göttingen, Germany
Halle, Germany
Hamburg, Germany
Hamm, Germany
Hannover, Germany
Homburg, Germany
Jena, Germany
Karlsruhe, Germany
Kiel, Germany
Lübeck, Germany
Magdeburg, Germany
Mainz, Germany
Muenchen, Germany
Mutlangen, Germany
München, Germany
Münster, Germany
Nürnberg, Germany
Oldenburg, Germany
Potsdam, Germany
Regensburg, Germany
Rehling, Germany
Rostock, Germany
Stuttgart, Germany
Tübingen, Germany
Ulm, Germany
Villingen-Schwenningen, Germany
Würzburg, Germany
Sponsors and Collaborators
Janssen-Cilag G.m.b.H
Investigators
Study Director: Janssen-Cilag G.m.b.H, Germany Clinical Trial Janssen-Cilag G.m.b.H
  More Information

No publications provided

Responsible Party: Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier: NCT00833560     History of Changes
Other Study ID Numbers: CR005242, 26866138MMY2031, 2005-003902-27
Study First Received: January 23, 2009
Results First Received: October 30, 2013
Last Updated: September 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

Keywords provided by Janssen-Cilag G.m.b.H:
Multiple Myeloma
Untreated multiple myeloma
Bortezomib
VELCADE
Cyclophosphamide
Dexamethasone
Chemotherapy
Remission therapy
Induction therapy
Stem Cell Transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Bortezomib
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Alkylating Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014