Clinical trial NCT02474563: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Bortezomib
Melphalan
Prednisone
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2015-06-17
Enrollment: 171
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: 2-year Progression-free Survival Rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Time to Response
timeFrame: up to 2 years
measure: Overall Response Rate
timeFrame: up to 2 years
measure: Complete Response Rate
timeFrame: up to 2 years
measure: Time to Next therapy
timeFrame: up to 2 years
measure: Time to Disease Progression
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Cheonan City
country: Korea, Republic of
city: Cheonan
country: Korea, Republic of
city: Chungcheongbuk-Do
country: Korea, Republic of
city: Dae-Gu
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Daejon
country: Korea, Republic of
city: Gyeonggi-Do
country: Korea, Republic of
city: Hwasun Gun
country: Korea, Republic of
city: Iksan
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeonju-Si
country: Korea, Republic of
city: Jinju-Si
country: Korea, Republic of
city: Pucheon
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seongnam
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Ulsan
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: