A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)
NCT ID: NCT03217812
Last Updated: 2024-04-25
Study Results
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Basic Information
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COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2017-11-23
2024-03-08
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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Treatment A: VMP Alone
Participants will receive Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 (if serum creatine is greater than \[\>\]2 milligram per deciliter \[mg/dL\] at baseline, participants must be administrated 4.5 mg/m\^2 of melphalan, instead of 9 mg/m\^2) orally, once daily (on Days 1 to 4) and prednisone 60 mg/m\^2, orally, once daily on Days 1 to 4 of each cycle up to Cycle 9.
Velcade
Participants will receive velcade 1.3 mg/m\^2, SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9 of Treatment Arm A and B.
Melphalan
Participants will receive melphalan 9 mg/m\^2 (if serum creatine is \>2 mg/dL at baseline, participants must be administrated 4.5 mg/m\^2 of melphalan, instead of 9 mg/m\^2), orally, once daily on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.
Prednisone
Participants will receive prednisone 60 mg/m\^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.
Treatment B: D-VMP
Participants will receive Velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 (if serum creatine is \>2 mg/dL at baseline, participants must be administrated 4.5 mg/m\^2 of melphalan, instead of 9 mg/m\^2), orally, once daily (on Days 1-4) and prednisone 60 mg/m\^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9. In addition participants will also receive daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion or daratumumab Subcutaneously (SC) at the discretion of the investigator, once weekly, for 6 weeks in Cycle 1 and then every 3 weeks, in Cycles 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or the end of study. Participants will receive pre-infusion medications before each daratumumab infusion.
Velcade
Participants will receive velcade 1.3 mg/m\^2, SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9 of Treatment Arm A and B.
Melphalan
Participants will receive melphalan 9 mg/m\^2 (if serum creatine is \>2 mg/dL at baseline, participants must be administrated 4.5 mg/m\^2 of melphalan, instead of 9 mg/m\^2), orally, once daily on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.
Prednisone
Participants will receive prednisone 60 mg/m\^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.
Daratumumab
Participants will receive daratumumab 16 mg/kg as IV infusion or daratumumab SC, once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or the end of study in Treatment Arm B.
Interventions
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Velcade
Participants will receive velcade 1.3 mg/m\^2, SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9 of Treatment Arm A and B.
Melphalan
Participants will receive melphalan 9 mg/m\^2 (if serum creatine is \>2 mg/dL at baseline, participants must be administrated 4.5 mg/m\^2 of melphalan, instead of 9 mg/m\^2), orally, once daily on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.
Prednisone
Participants will receive prednisone 60 mg/m\^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.
Daratumumab
Participants will receive daratumumab 16 mg/kg as IV infusion or daratumumab SC, once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or the end of study in Treatment Arm B.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed and not considered candidate for high-dose chemotherapy with stem cell transplantation (SCT) due to: being age \>= 65 years, or in participants less than (\<) 65 years: presence of important comorbid conditions likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Meet the clinical laboratory criteria as specified in the protocol
* A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization
Exclusion Criteria
* Waldenstrom's disease, or other conditions in which Immunoglobulin M (IgM) M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
* Prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 milligram per day (mg/day) for 4 days) of corticosteroids before treatment
* Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute common terminology criteria for adverse events (NCI-CTCAE), Version 4.03
* History of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
* Radiation therapy within 14 days of randomization
* Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[Anti-HBc\] and/or antibodies to hepatitis B surface antigen \[Anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
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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Beijing Chaoyang Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Beijing Chaoyang Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
The Third Xiangya Hospital, Central South University
Changsha, , China
West China Hospital Si Chuan University
Chengdu, , China
Second Affiliated Hospital of Army 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
Harbin medical university cancer hospital
Harbin, , 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
Shanghai Zhongshan Hospital
Shanghai, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
First Affiliated Hospital SooChow University
Suzhou, , China
Tianjin cancer hospital
Tianjin, , China
Institute of Hematology and Blood Diseases Hospital
Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, , China
Tangdu Hospital
Xi'an, , China
Henan Cancer Hospital
Zhengzhou, , China
Queen Mary Hospital University of Hong Kong
Hong Kong, , Hong Kong
Hospital Ampang
Ampang, , Malaysia
Hospital Pulau Pinang
George Town, , Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, , Malaysia
Inje University Busan Paik Hospital
Busan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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References
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Fu W, Bang SM, Huang H, Kim K, Li W, An G, Lee JJ, Cai Z, Jin J, Wang Y, Chim CS, Carson R, Liu R, Zhao M, Chen X, Cui C, Hou J, Wang J. Health-related quality of life with daratumumab, bortezomib, melphalan, and prednisone versus bortezomib, melphalan, and prednisone alone in transplant-ineligible patients with newly diagnosed multiple myeloma: analysis of the phase 3 OCTANS study. Ann Hematol. 2025 May;104(5):2765-2776. doi: 10.1007/s00277-025-06303-3. Epub 2025 May 23.
Fu W, Bang SM, Huang H, Kim K, Li W, An G, Lee JJ, Cai Z, Jin J, Wang Y, Chim CS, Carson R, Liu R, Zhao M, Chen X, Cui C, Hou J, Wang J. Daratumumab, bortezomib, melphalan, and prednisone versus bortezomib, melphalan, and prednisone alone in transplant-ineligible Asian patients with newly diagnosed multiple myeloma: final analysis of the phase 3 OCTANS Study. Ann Hematol. 2025 Jan;104(1):515-525. doi: 10.1007/s00277-024-05958-8. Epub 2024 Sep 4.
Fu W, Bang SM, Huang H, Kim K, Li W, An G, Lee JJ, Cai Z, Jin J, Wang Y, Lin TL, Chim CS, Qi M, Wang J, Lu X, Song Y, Jia B, Yang X, Liu W, Zhou T, Yin L, Li Y, Zhang R, Hou J, Wang J. Bortezomib, Melphalan, and Prednisone With or Without Daratumumab in Transplant-ineligible Asian Patients With Newly Diagnosed Multiple Myeloma: The Phase 3 OCTANS Study. Clin Lymphoma Myeloma Leuk. 2023 Jun;23(6):446-455.e4. doi: 10.1016/j.clml.2023.02.009. Epub 2023 Mar 4.
Other Identifiers
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54767414MMY3011
Identifier Type: OTHER
Identifier Source: secondary_id
CR108340
Identifier Type: -
Identifier Source: org_study_id
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