NCT03217812CompletedPhase 3
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)
A Phase 3, Multicenter, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)
Source: ClinicalTrials.gov · Last updated 25 Apr 2024
Brief summary (registry, in English)
The purpose of this study is to determine if the addition of daratumumab to VELCADE-melphalan-prednisone (VMP) will improve very good partial response (VGPR) or better compared with VMP alone.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (actual)
- First submitted
- 13 Jul 2017
- Start date
- 23 Nov 2017
- Primary completion date
- 2 Jul 2020
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Multiple myeloma
- NCT number
- NCT03217812
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 220
- From 23 Nov 2017 to the primary completion date, 2 Jul 2020
- 43 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
- 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)
Other
- Primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma
Who the study is looking for
- Documented multiple myeloma satisfying the calcium elevation, renal insufficiency, anemia, and bone abnormalities (CRAB) diagnostic criteria, monoclonal plasma cells in the bone marrow greater than or equal to (\>=) 10 percent (%) or presence of a biopsy proven plasmacytomas, and measurable secretory disease, as assessed by the central laboratory, and defined in protocol
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (43)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing ChaoYang Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Third Xiangya Hospital, Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital Si Chuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Second Affiliated Hospital of Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Meidical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| First Affiliated Hospital Medical School of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| First Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Zhongda Hospital Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Renji Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| First Affiliated Hospital SooChow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tianjin Cancer Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Institute of Hematology and Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Tongji Hospital Tongji Medical College of Hust Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tangdu Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Queen Mary Hospital University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Inje University Busan Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Hospital Ampang Coordinator of this site? Confirm its status | Ampang | Malaysia | Unknown status |
| Hospital Pulau Pinang Coordinator of this site? Confirm its status | George Town | Malaysia | Unknown status |
| Hospital Queen Elizabeth Coordinator of this site? Confirm its status | Kota Kinabalu | Malaysia | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.