Clinical trial NCT03234972: A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Randomized, Multicenter, Open-label, Phase 3 Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Subjects With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to compare the efficacy of daratumumab when combined with Velcade (bortezomib) and dexamethasone (DVd) to that of Velcade and dexamethasone (Vd), in terms of progression free survival (PFS) in Chinese participants with relapsed or refractory multiple myeloma (MM).


Eligibility criteria: Inclusion Criteria:

* Documented multiple myeloma (MM) as defined by the criteria: monoclonal plasma cells in the bone marrow greater than or equal to (\>=) 10 percent (%) at some point in the participant's disease course or presence of a biopsy-proven plasmacytoma
* Received at least 1 prior line of therapy for MM
* Documented evidence of progressive disease (PD) based on investigator's determination of response as defined by the International Myeloma Working Group (IMWG) criteria on or after their last regimen
* Achieved a response (partial response \[PR\] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2

Exclusion Criteria:

* Received daratumumab or other anti-CD38 therapies
* Refractory to Velcade, or another proteasome inhibitor (PI), like ixazomib and carfilzomib (ie, participant had progression of disease while receiving Velcade therapy or within 60 days of ending Velcade therapy, or another PI, like ixazomib and carfilzomib, etc)
* Intolerant to Velcade (that is \[ie\], discontinued due to any adverse event while on Velcade treatment)
* Planning to undergo a stem cell transplant prior to progression of disease on this study, that is ie, these participants should not be enrolled in order to reduce disease burden prior to transplant
* History of malignancy (other than MM) within 3 years before the date of randomization

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From the date of randomization to either progressive disease (PD) or death, whichever occurs first (approximately up to 4.5 years)
Secondary outcomes:
measure: Time to Disease Progression (TTP)
timeFrame: From the date of randomization to the date of first documented evidence of PD (approximately up to 4.5 years)
measure: Overall Response Rate (ORR)
timeFrame: Approximately up to 4.5 years
measure: Percentage of Participants With a Very Good Partial Response (VGPR) or Better
timeFrame: Approximately up to 4.5 years
measure: Time to Response
timeFrame: From the date of randomization and the first efficacy evaluation that the participant has met all criteria for response (PR or better rate) (approximately up to 4.5 years)
measure: Duration of Response
timeFrame: From the date of initial documentation of a response (PR or better rate) to the date of first documented evidence of PD (approximately up to 4.5 years)
measure: Overall Survival
timeFrame: From date of randomization to the date of the participant's death (approximately up to 4.5 years)
measure: Change From Baseline in Euro Quality of Life 5-Dimensions 5-Level (EQ-5D-5L) Utility Score
timeFrame: Baseline up to Weeks 8 and 16 post PD (Approximately up to 4.5 years)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
timeFrame: Baseline up to Weeks 8 and 16 post PD (Approximately up to 4.5 years)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People s Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital Si Chuan University
city: Chongqing
country: China
facility: Xinqiao Hospital of the Third Military Medical University
city: Fuzhou
country: China
facility: Fujian Meidical University Union Hospital
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun Yat sen University
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Hangzhou
country: China
facility: First Affiliated Hospital Medical School of Zhejiang University
city: Hangzhou
country: China
facility: First affiliated Hospital of Zhejiang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University
city: Suzhou
country: China
facility: First Affiliated Hospital SooChow University
city: Tianjin
country: China
facility: Tianjin cancer hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
city: Xian
country: China
facility: Tangdu Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Lu J, Fu W, Li W, Hu J, An G, Wang Y, Fu C, Chen L, Jin J, Cen X, Ge Z, Cai Z, Niu T, Qi M, Sun S, Gai X, Liu W, Liu W, Yang X, Huang X. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Chinese Patients with Relapsed or Refractory Multiple Myeloma: Phase 3 LEPUS (MMY3009) Study. Clin Lymphoma Myeloma Leuk. 2021 Sep;21(9):e699-e709. doi: 10.1016/j.clml.2021.04.012. Epub 2021 Apr 24.