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NCT Number: NCT02474563

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

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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anyang, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

bortezomib

Drug

Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study.

melphalan

Drug

Participants receiving Melphalan 9 mg/m^2 will be observed in this study.

Prednisone

Drug

Participants receiving Prednisone 60 mg/m^2 will be observed in this study.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 17, 2015
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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