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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

Brief Summary:
The purpose of this study is to assess the 2-year progression-free survival rate.

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Bortezomib Drug: Melphalan Drug: Prednisone

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.

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Study Type : Observational
Actual Enrollment : 171 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : May 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014


Group/Cohort Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Overall Response Rate [ Time Frame: up to 2 years ]
    Percentage of participants who achieved CR, VGPR or PR in 2 years.

  3. Complete Response Rate [ Time Frame: up to 2 years ]
    Percentage of participants who achieved CR as best response.

  4. 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.

  5. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474563


Locations
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Korea, Republic of
Anyang, Korea, Republic of
Busan, Korea, Republic of
Cheonan City, Korea, Republic of
Cheonan, Korea, Republic of
Chungcheongbuk-Do, Korea, Republic of
Dae-Gu, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Daejon, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Hwasun Gun, Korea, Republic of
Iksan, Korea, Republic of
Incheon, Korea, Republic of
Jeonju-Si, Korea, Republic of
Jinju-Si, Korea, Republic of
Pucheon, Korea, Republic of
Pusan, Korea, Republic of
Seongnam, Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Ulsan, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
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Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea

Additional Information:
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Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT02474563     History of Changes
Other Study ID Numbers: CR018445
26866138MMY4056 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Keywords provided by Janssen Korea, Ltd., Korea:
Multiple Myeloma
Bortezomib
Melphalan
Prednisone

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Bortezomib
Melphalan
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors