A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT03234972
Last Updated: 2024-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
213 participants
INTERVENTIONAL
2017-11-30
2024-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Daratumumab, Velcade, and Dexamethasone (DVd)
Participants will receive daratumumab weekly for the first 3 cycles, every 3 weeks (q3w) on Day 1 of Cycles 4-9 as an intravenous (IV) infusion at a dose of 16 milligram per kilogram (mg/kg) or will have the option to switch to daratumumab subcutaneously (SC) on Day 1 of any cycle, and then every 4 weeks (q4w) thereafter, Velcade at a dose of 1.3 milligram per square meter (mg/m\^2) subcutaneous (SC) on Days 1, 4, 8 and 11 of each 21-day cycle (up to 8 treatment cycles) and dexamethasone (Dex) orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the 8 Velcade treatment cycles.
Daratumumab
Daratumumab will be administered on Day 1 of Cycles 4-9, and then q4w thereafter.
Velcade
Velcade will be administered at a dose of 1.3 mg/m\^2 SC on Days 1, 4, 8 and 11 of each 21-day cycle.
Dexamethasone
Dex will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 Velcade treatment cycles.
Arm B: Velcade and Dexamethasone (Vd)
Participants will receive Velcade SC at a dose of 1.3 mg/m\^2 SC on Days 1, 4, 8 and 11 of each 21-day cycle and Dex 20 mg PO on Days 1, 2, 4, 5, 8, 9, 11, 12 (up to 8 cycles). Participants who have sponsor-confirmed disease progression while being treated with Vd or on observation, will be offered the option for treatment with daratumumab monotherapy (16 mg/kg weekly for Cycles 1 and 2, every other week for Cycles 3 to 6, and every 4 weeks for Cycles 7 and onwards until disease progression, unacceptable toxicity, pregnancy, loss of follow-up, withdrawal of consent, or death \[each cycle is 28 days\]), if recommended by the site investigator.
Daratumumab
Daratumumab will be administered on Day 1 of Cycles 4-9, and then q4w thereafter.
Velcade
Velcade will be administered at a dose of 1.3 mg/m\^2 SC on Days 1, 4, 8 and 11 of each 21-day cycle.
Dexamethasone
Dex will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 Velcade treatment cycles.
Interventions
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Daratumumab
Daratumumab will be administered on Day 1 of Cycles 4-9, and then q4w thereafter.
Velcade
Velcade will be administered at a dose of 1.3 mg/m\^2 SC on Days 1, 4, 8 and 11 of each 21-day cycle.
Dexamethasone
Dex will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 Velcade treatment cycles.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Peking Union Medical College Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Peking University People s Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
West China Hospital Si Chuan University
Chengdu, , China
Xinqiao Hospital of the Third Military Medical University
Chongqing, , China
Fujian Meidical University Union Hospital
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, , China
Nanfang Hospital
Guangzhou, , China
First Affiliated Hospital Medical School of Zhejiang University
Hangzhou, , China
First affiliated Hospital of Zhejiang University
Hangzhou, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Zhongda Hospital Southeast University
Nanjing, , China
Jiangsu Province Hospital
Nanjing, , China
Shanghai Changzheng Hospital
Shanghai, , China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, , China
First Affiliated Hospital SooChow University
Suzhou, , China
Tianjin cancer hospital
Tianjin, , China
Tianjin Medical University General Hospital
Tianjin, , China
Institute of Hematology and Blood Diseases Hospital
Tianjin, , China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, , China
Tangdu Hospital
Xi'an, , China
Henan Cancer Hospital
Zhengzhou, , China
National Taiwan University Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Countries
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References
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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, Gai X, Li Q, Liu W, Liu W, Yang X, Chen X, Lu J. Daratumumab, Bortezomib, and Dexamethasone versus Bortezomib and Dexamethasone in Chinese Patients With Relapsed or Refractory Multiple Myeloma: Updated Analysis of LEPUS. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):e51-e58. doi: 10.1016/j.clml.2022.10.007. Epub 2022 Oct 23.
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.
Other Identifiers
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54767414MMY3009
Identifier Type: OTHER
Identifier Source: secondary_id
CR104378
Identifier Type: -
Identifier Source: org_study_id
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