Multiple Myeloma Clinical Trial
Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant
Summary
Primary Objective:
-To demonstrate the benefit of treatment-a-promising-new-option-for-relapsed-multiple-myeloma/" >isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.
Secondary Objectives:
To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms:
Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria.
Minimal residual disease (MRD) negativity rate in patients with CR.
Very good partial response or better rate, as defined by the IMWG criteria.
Overall survival (OS).
To evaluate the overall response rate (ORR) as per IMWG criteria.
To evaluate the time to progression (TTP) overall and by MRD status.
To evaluate PFS by MRD status.
To evaluate the duration of response (DOR) overall and by MRD status.
To evaluate time to first response (TT1R).
To evaluate time to best response (TTBR).
To evaluate progression-free survival on next line of therapy (PFS2).
To evaluate the sustained MRD negativity >12 months rate.
To evaluate safety.
To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only).
To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (IVRd and crossover arms).
To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.
Full Description
The duration of the study for each patient will include a screening period of up to 4 weeks, an induction period of 24 weeks (4 cycles with a duration of 42 ± 3 days), a continuous treatment period and a crossover period (when applicable). The cycle duration is 28 ± 3 days during the continuous treatment and crossover periods.
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria :
Multiple myeloma (IMWG criteria).
Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or patients < 65 years with comorbidities impacting possibility of transplant.
Evidence of measurable disease.
Written informed consent.
Exclusion criteria:
Age < 18 years.
Prior treatment for multiple myeloma.
Any other prior or ongoing disease/health conditions incompatible with the study objectives.
Organ function values not met.
Eastern Cooperative Oncology Group (ECOG) Performance Status ( PS) > 2.
Hypersensitivity to the study medications.
Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods.
Male participants who disagree to follow the study contraceptive counseling.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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There are 101 Locations for this study
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33705, United States
Kansas City Missouri, 64132, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Liverpool New South Wales, 2170, Australia
Waratah New South Wales, 2298, Australia
Wollongong New South Wales, 2500, Australia
South Brisbane Queensland, 4101, Australia
Clayton Victoria, 3168, Australia
Heidelberg West Victoria, 3081, Australia
Nedlands Western Australia, 6009, Australia
West Perth Western Australia, 6005, Australia
Liège , 4000, Belgium
Beijing , 10003, China
Beijing , 10019, China
Changchun , 13002, China
Fuzhou , 35000, China
Guangzhou , 51006, China
Guangzhou , 51008, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Nanjing , 21002, China
Shanghai , 20002, China
Shenyang , 11002, China
Tianjin , 30002, China
Wuhan , 43002, China
Brno , 62500, Czechia
Hradec Kralove , 50005, Czechia
Olomouc , 77900, Czechia
Ostrava - Poruba , 70852, Czechia
Plzen , 30599, Czechia
Praha 2 , 12808, Czechia
Aalborg , 9000, Denmark
Aarhus N , 8200, Denmark
Odense C , 5000, Denmark
Bayonne , 64100, France
Caen , 14033, France
Dijon , 21000, France
La Roche Sur Yon , 85925, France
Lille , 59037, France
Nantes , 44093, France
Paris , 75012, France
Pessac , 33600, France
Pierre Benite , 69495, France
Poitiers Cedex , 86021, France
TOULOUSE Cedex 9 , 31059, France
Vandoeuvre-les-nancy , 54511, France
Berlin , 13125, Germany
Frankfurt am Main , 60590, Germany
Heidelberg , 69120, Germany
Tübingen , 72076, Germany
Athens , 10676, Greece
Athens , 11528, Greece
Thessaloniki , 57010, Greece
Ancona , 60032, Italy
Bergamo , 24127, Italy
Bologna , 40138, Italy
Brescia , 25123, Italy
Torino , 10126, Italy
Nagoya-shi Aichi, 467-8, Japan
Higashiibaraki-gun Ibaraki, 311-3, Japan
Konan-ku, Yokohama-shi Kanagawa, 234-0, Japan
Kumamoto-shi Kumamoto, 860-8, Japan
Sendai-shi Miyagi, 983-8, Japan
Okayama-shi Okayama, 701-1, Japan
Sunto-gun Shizuoka, 411-8, Japan
Shibuya-ku Tokyo, 150-8, Japan
Shinjuku-ku Tokyo, 162-8, Japan
Yamagata-shi , 990-9, Japan
Klaipeda , LT-92, Lithuania
Vilnius , 08661, Lithuania
Monterrey Nuevo León, 64460, Mexico
Takapuna Auckland, 1309, New Zealand
Hamilton Waikato, 3204, New Zealand
Auckland , 2025, New Zealand
Lodz Lódzkie, 93-51, Poland
Warszawa Mazowieckie, 02-78, Poland
Gdansk Pomorskie, 80-95, Poland
Poznan Wielkopolskie, 60-63, Poland
Braga , 4710-, Portugal
Coimbra , 3000-, Portugal
Lisboa , 1070, Portugal
Porto , 4200-, Portugal
Porto , 4200, Portugal
Moscow , 12528, Russian Federation
Moscow , 12930, Russian Federation
Barcelona Barcelona [Barcelona], 08035, Spain
Barcelona Barcelona [Barcelona], 08041, Spain
Madrid , 28034, Spain
Murcia , 30008, Spain
Lund , 221 8, Sweden
Stockholm , 14186, Sweden
Changhua , 500, Taiwan
Taichung , 40447, Taiwan
Taipei , 100, Taiwan
Adana , 01250, Turkey
Ankara , 06500, Turkey
Ankara , , Turkey
Istanbul , 34390, Turkey
Izmir , 35040, Turkey
Izmir , 35340, Turkey
Kayseri , 38039, Turkey
Samsun , 55139, Turkey
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