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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
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

Full criteria on ClinicalTrials.gov

Sites (43)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University First Hospital
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BeijingChinaUnknown status
Beijing ChaoYang Hospital
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Peking Union Medical College Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
The Third Xiangya Hospital, Central South University
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ChangshaChinaUnknown status
West China Hospital Si Chuan University
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ChengduChinaUnknown status
Second Affiliated Hospital of Army Medical University
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ChongqingChinaUnknown status
Fujian Meidical University Union Hospital
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FuzhouChinaUnknown status
Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
Nanfang Hospital
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
First Affiliated Hospital Medical School of Zhejiang University
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HangzhouChinaUnknown status
First Affiliated Hospital of Zhejiang University
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Jiangsu Province Hospital
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NanjingChinaUnknown status
Zhongda Hospital Southeast University
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NanjingChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
Shanghai Changzheng Hospital
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ShanghaiChinaUnknown status
Renji Hospital, Shanghai Jiaotong University School of Medicine
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ShanghaiChinaUnknown status
Ruijin Hospital Shanghai Jiao Tong University
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ShanghaiChinaUnknown status
Shanghai Zhongshan Hospital
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ShanghaiChinaUnknown status
First Affiliated Hospital SooChow University
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SuzhouChinaUnknown status
Tianjin Cancer Hospital
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TianjinChinaUnknown status
Institute of Hematology and Blood Diseases Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Tongji Hospital Tongji Medical College of Hust
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WuhanChinaUnknown status
Tangdu Hospital
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Xi'anChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Queen Mary Hospital University of Hong Kong
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Hong KongHong Kong SAR ChinaUnknown status
Inje University Busan Paik Hospital
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BusanSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Hospital Ampang
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AmpangMalaysiaUnknown status
Hospital Pulau Pinang
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George TownMalaysiaUnknown status
Hospital Queen Elizabeth
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Kota KinabaluMalaysiaUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.