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Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02474563
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Tracking Information
First Submitted Date June 15, 2015
First Posted Date June 17, 2015
Last Update Posted Date June 30, 2015
Study Start Date May 2011
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2015)
2-year Progression-free Survival Rate [ Time Frame: Up to 2 years ]
Progression-free survival rate: the length of time from the day when Bortezomib was first administered to disease progression or death, whichever comes first, in 2 years.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02474563 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 26, 2015)
  • Time to Response [ Time Frame: up to 2 years ]
    Time from the first day of Bortezomib administration to the day of confirmed first response in participants with confirmed response, or to the day of loss to follow-up, disease progression, death or completion of study therapy in participants without response.
  • Overall Response Rate [ Time Frame: up to 2 years ]
    Percentage of participants who achieved CR, VGPR or PR in 2 years.
  • Complete Response Rate [ Time Frame: up to 2 years ]
    Percentage of participants who achieved CR as best response.
  • Time to Next therapy [ Time Frame: up to 2 years ]
    The next therapy after the end of the study therapy was investigated, and the time from the day when the first therapy was started to the day when the next therapy was started was calculated.
  • Time to Disease Progression [ Time Frame: up to 2 years ]
    Time from the first day of Bortezomib administration to the day of disease progression or relapse from complete response, whichever comes first.
Original Secondary Outcome Measures
 (submitted: June 15, 2015)
  • Time to Response [ Time Frame: up to 2 years ]
    Time from the first day of Bortezomib administration to the day of confirmed first response in participants with confirmed response, or to the day of loss to follow-up, disease progression, death or completion of study therapy in participants without response.
  • Overall Response Rate [ Time Frame: up to 2 years ]
    Percentage of participants who achieved CR, VGPR or PR in 2 years.
  • Complete Response Rate [ Time Frame: up to 2 years ]
    Percenatge of participants who achieved CR as best response.
  • Time to Next therapy [ Time Frame: up to 2 years ]
    The next therapy after the end of the study therapy was investigated, and the time from the day when the first therapy was started to the day when the next therapy was started was calculated.
  • Time to Disease Progression [ Time Frame: up to 2 years ]
    Time from the first day of Bortezomib administration to the day of disease progression or relapse from complete response, whichever comes first.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma
Official Title A Prospective, Open-label, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone(VMP) for Initial Treatment in Patients With Multiple Myeloma Who do Not Undergo Autologous Stem Cell Transplantation
Brief Summary The purpose of this study is to assess the 2-year progression-free survival rate.
Detailed Description This was a prospective, open-label, multicenter, observational study. Participants who received bortezomib, Melphalan, Prednisone(VMP) therapy for Multiple myeloma (MM) that was not eligible for autologous stem cell transplantation will be enrolled in the study. The study will consist of Screening phase; VMP therapy phase (9cycles); Follow-up phase (2 years from the day when the first cycle was started). Participants visited each institution for evaluation for 2 years from the date of baseline evaluation and first VMP administration (duration of treatment, 9 cycles; follow-up visits, every 3 months after the end of the treatment). Participants receiving VMP therapy will be primarily evaluated for 2-year progression-free survival rate. Participants safety will be monitored throughout the study.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
Condition Multiple Myeloma
Intervention
  • Drug: Bortezomib
    Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study.
  • Drug: Melphalan
    Participants receiving Melphalan 9 mg/m^2 will be observed in this study.
  • Drug: Prednisone
    Participants receiving Prednisone 60 mg/m^2 will be observed in this study.
Study Groups/Cohorts Bortezomib, Melphalan, Prednisone (VMP) Group
Participants will not receive any intervention in this study. Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
Interventions:
  • Drug: Bortezomib
  • Drug: Melphalan
  • Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 15, 2015)
171
Original Actual Enrollment Same as current
Actual Study Completion Date May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants who are naïve to chemotherapy for multiple myeloma and not eligible for autologous stem cell transplantation
  • Participants with symptomatic multiple myeloma: a) Intramedullary monoclonal plasma cells greater than or equal to (>=) 10% or histologically confirmed plasmacytoma; b) Presence of monoclonal protein in the serum or urine; c) Myeloma-related organ impairment as defined in protocol
  • Participants with presence of an illness that is detectable by definitions as defined in protocol
  • Postmenopausal, sterilized or sexually inactive women, including women of childbearing potential who exercise effective contraceptive measures before and during the clinical trial

Exclusion Criteria:

  • Participants with previous experience of receiving a therapy for multiple myeloma (excluding radiotherapy and dexamethasone < 160mg in total)
  • Participants with severe peripheral neuropathy (Grade >= 2 by NCI CTC version 4.0)
  • Pregnant or breastfeeding mothers
  • Participants with mental illness that can interfere with his/her cooperation with the therapy or the monitoring conditions of the clinical trial
  • Participants with other serious medical conditions (such as uncontrolled hypertension, diabetes mellitus and active infections)
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02474563
Other Study ID Numbers CR018445
26866138MMY4056 ( Other Identifier: Janssen Korea, Ltd., Korea )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Janssen Korea, Ltd., Korea
Study Sponsor Janssen Korea, Ltd., Korea
Collaborators Not Provided
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
PRS Account Janssen Korea, Ltd., Korea
Verification Date June 2015