Multiple Myeloma Clinical Trial
A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma
Summary
The purpose of this study is to determine if the addition of daratumumab to velcade (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared with VMP alone in participants with previously untreated multiple myeloma who are ineligible for high dose chemotherapy and autologous stem cell transplant (ASCT).
Full Description
The study consists of 3 phases: Screening Phase (within 21 days prior to randomization), Treatment Phase (Cycle 1 Day 1 to discontinuation of all study treatment), and Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, withdrawal of consent, or the study ends, whichever occurs first). Treatment phase will include 2 treatments (Treatment A: participants will receive Velcade MelphalanPrednisone (VMP) alone and Treatment B: participants will receive daratumumab in combination with VMP).Two interim analyses are planned. The first will be to evaluate safety after a total of approximately 100 participants have been treated for at least 2 cycles or discontinued the study treatment. The second will be to evaluate cumulative interim safety and efficacy data, and will be performed when approximately 216 PFS events have been accumulated. The final OS analysis will occur when approximately 382 deaths have occurred. Efficacy will be primarily measured by comparison of PFS between the two treatment arms. Participants' safety will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria:
Participant must have 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 plasmacytoma, and measurable secretory disease, as assessed by the central laboratory, and defined in protocol
Participants who are newly diagnosed and not considered candidate for high-dose chemotherapy with stem cell transplantation (SCT) due to: being age >=65 years, or in participants <65 years: presence of important comorbid conditions likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation
Participant must have an 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 pregnancy test at screening within 14 days prior to randomization
Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy
Exclusion Criteria:
Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma
Participant has a diagnosis of Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
Participant has 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 mg/day for 4 days) of corticosteroids before treatment
Participant has 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
Participant has a 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)
Participant has had radiation therapy within 14 days of randomization
Participant has had plasmapheresis within 28 days of randomization
Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second [FEV1] <50% of predicted normal), known moderate or severe persistent asthma within the last 2 years or currently has uncontrolled asthma of any classification (controlled intermittent asthma or controlled mild persistent asthma is allowed)
Participants with known or suspected COPD must have a FEV1 test during screening
Participant is known to be seropositive for human immunodeficiency virus (HIV), known to have hepatitis B surface antigen positivity, or history of to have a history of hepatitis C
Participant has any concurrent medical or psychiatric condition or disease (example active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
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There is 1 Location for this study
California City California, , United States
Corona California, , United States
Fountain Valley California, , United States
Los Angeles California, , United States
Hialeah Florida, , United States
Orange Park Florida, , United States
Chicago Illinois, , United States
Springfield Missouri, , United States
Cleveland Ohio, , United States
Fredericksburg Virginia, , United States
Buenos Aires , , Argentina
Ciudad Autonoma Buenos Aires , , Argentina
Córdoba , , Argentina
Santa Fe , , Argentina
Adelaide , , Australia
Bendigo , , Australia
Camperdown N/a , , Australia
Geelong , , Australia
Gosford , , Australia
Greenslopes , , Australia
Hobart , , Australia
North Adelaide , , Australia
Parkville , , Australia
Antwerpen , , Belgium
Antwerp , , Belgium
Brussel , , Belgium
Charleroi , , Belgium
Gent , , Belgium
Kortrijk , , Belgium
Roeselare , , Belgium
Turnhout , , Belgium
Yvoir , , Belgium
Barretos , , Brazil
Cuiaba - Mount , , Brazil
Fortaleza , , Brazil
Goiania , , Brazil
Natal , , Brazil
Porto Alegre , , Brazil
Ribeirao Preto , , Brazil
Rio de Janeiro , , Brazil
Sao Paulo , , Brazil
São Paulo , , Brazil
Pleven , , Bulgaria
Plovdiv , , Bulgaria
Sofia , , Bulgaria
Varna , , Bulgaria
Vratsa , , Bulgaria
Zadar , , Croatia
Zagreb , , Croatia
Brno , , Czechia
Hradec Kralove , , Czechia
Olomouc , , Czechia
Ostrava-Poruba , , Czechia
Praha 10 , , Czechia
Praha 2 , , Czechia
Tbilisi , , Georgia
Berlin , , Germany
Dortmund , , Germany
Karlsruhe , , Germany
Potsdam , , Germany
Saarbrücken , , Germany
Stuttgart , , Germany
Würzburg , , Germany
Athens Attica , , Greece
Athens , , Greece
Patra , , Greece
Thessaloniki , , Greece
Budapest , , Hungary
Debrecen , , Hungary
Kaposvar , , Hungary
Pecs N/a , , Hungary
Chiba , , Japan
Hitachi , , Japan
Kanazawa , , Japan
Kawasaki , , Japan
Kobe , , Japan
Kurume , , Japan
Matsuyama , , Japan
Nagoya , , Japan
Narita , , Japan
Ohgaki , , Japan
Okayama , , Japan
Osaka , , Japan
Sendai-shi , , Japan
Shibukawa , , Japan
Shibuya , , Japan
Tachikawa , , Japan
Toyohashi , , Japan
Busan , , Korea, Republic of
Gyeonggi-do , , Korea, Republic of
Hwasun , , Korea, Republic of
Incheon , , Korea, Republic of
Seongnam , , Korea, Republic of
Seoul , , Korea, Republic of
Skopje , , North Macedonia
Bialystok , , Poland
Bydgoszcz , , Poland
Chorzow , , Poland
Gdansk , , Poland
Legnica , , Poland
Lublin , , Poland
Opole , , Poland
Slupsk , , Poland
Warszawa Ul , , Poland
Warszawa , , Poland
Wroclaw , , Poland
Lisboa , , Portugal
Lisbon , , Portugal
Porto , , Portugal
Brasov , , Romania
Bucharest , , Romania
Iasi , , Romania
Arkhangelsk , , Russian Federation
Dzerzhinsk , , Russian Federation
Ekaterinbourg , , Russian Federation
Nizhny Novgorod , , Russian Federation
Ryazan , , Russian Federation
Saint-Petersburg , , Russian Federation
Saratov , , Russian Federation
Sochi , , Russian Federation
St Petersburg , , Russian Federation
Volgograd , , Russian Federation
Belgrade , , Serbia
Nis , , Serbia
Novi Sad , , Serbia
Sremska Kamenica , , Serbia
Zemun , , Serbia
Andalucía , , Spain
Badalona , , Spain
Barcelona , , Spain
Córdoba , , Spain
Girona , , Spain
La Laguna , , Spain
Madrid , , Spain
Maranon , , Spain
Murcia N/a , , Spain
Ourense , , Spain
Pamplona , , Spain
Salamanca , , Spain
Sevilla , , Spain
Toledo , , Spain
Valencia , , Spain
Zaragoza , , Spain
Altindag , , Turkey
Ankara , , Turkey
Aydin , , Turkey
Izmir , , Turkey
Kayseri , , Turkey
Samsun , , Turkey
Tekirdag , , Turkey
Cherkassy , , Ukraine
Dnepropetrovsk , , Ukraine
Ivano-Frankivsk , , Ukraine
Kharkov , , Ukraine
Khmelnitskiy , , Ukraine
Lviv , , Ukraine
Zaporizhzhia , , Ukraine
Birmingham , , United Kingdom
Cambridge , , United Kingdom
Colchester , , United Kingdom
Harlow , , United Kingdom
Leicester , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
Woolwich , , United Kingdom
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