Clinical trial NCT05405166: SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Official title: A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Plasma Cell Myeloma Recurrent
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-06-06
Enrollment: 531
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms:

Arm SC: Isatuximab SC + Pd

Arm IV: Isatuximab IV + Pd

Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

Detailed description: Two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

Eligibility criteria: Inclusion Criteria:

* Participants with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
* Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (\<0.26 or \>1.65)).

Exclusion Criteria:

* Primary refractory multiple myeloma participants
* Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
* Prior therapy with pomalidomide
* Participants with inadequate biological tests.
* Significant cardiac dysfunction
* Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
* Concomitant plasma cell leukemia
* Active primary amyloid light -chain amyloidosis
* Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
* Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
* Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to approximately 2 years
measure: Observed concentration before dosing (Cthrough) at steady state
timeFrame: Predose at Cycle 6 Day 1 (duration of each cycle is 28 days)
Secondary outcomes:
measure: Very Good Partial Response or better rate (VGPR)
timeFrame: Up to approximately 2 years
measure: Observed concentration before dosing (Ctrough)
timeFrame: At 4 weeks i.e., predose at Cycle 2 Day 1 (duration of each cycle is 28 days)
measure: Incidence rate of infusion-reactions
timeFrame: Up to approximately 4 years
measure: Percentage of participants satisfied or very satisfied with the injection method used to administer study medication
timeFrame: At Cycle 5 Day 15
measure: Duration of response (DOR)
timeFrame: Up to approximately 2 years
measure: Time to first response (TT1R)
timeFrame: Up to approximately 2 years
measure: Time to best response (TTBR)
timeFrame: Up to approximately 2 years
measure: Progression free survival (PFS)
timeFrame: Up to approximately 4 years
measure: Overall survival (OS)
timeFrame: Up to approximately 4 years
measure: Progression free survival 2 (PFS2)
timeFrame: Up to approximately 4 years
measure: Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs).
timeFrame: Up to approximately 4 years
measure: Pharmacokinetic (PK) parameter
timeFrame: Up to approximately 4 years
measure: PK parameter
timeFrame: Up to approximately 4 years
measure: Successful injection rate
timeFrame: Up to approximately 4 years
measure: Percentage of participants with anti-drug antibodies (ADA) against isatuximab
timeFrame: Up to approximately 4 years
measure: Participant expectation questionnaire-baseline (PEQ-BL) score
timeFrame: Cycle 1 Day 1 ((duration of each cycle is 28 days)
measure: Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score
timeFrame: Up to approximately 4 years
measure: Patient experience and satisfaction questionnaire-end of treatment (PESQ-EOT) score
timeFrame: Up to approximately 4 years
measure: Patient's Assessment of Treatment (PAT) questionnaire score
timeFrame: Up to approximately 4 years
measure: Change from baseline in the Health Resource Utilization and Productivity Questionnaire (HRUPQ) scores
timeFrame: Baseline; up to approximately 4 years
measure: Change from baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score
timeFrame: Baseline; up to approximately 4 years
measure: Change from baseline in European Organization for Research and Treatment of Cancer quality of life myeloma module (EORTC QLQ-MY20)
timeFrame: Baseline; up to approximately 4 years
measure: Change from baseline in the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) scores
timeFrame: Baseline; up to approximately 4 years
measure: Number of participants with chromosomal abnormalities
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Bullhead City
country: United States
facility: Mohtaseb Cancer Center and Blood Disorders Site Number : 8400028
state: Arizona
city: Prescott Valley
country: United States
facility: Arizona Oncology Associates, PC - HAL- Site Number : 8400015
state: Arizona
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers, LLP- Site Number : 8400021
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic- Site Number : 8400008
state: Florida
city: Plantation
country: United States
facility: BRCR Medical Center Inc Site Number : 8400030
state: Florida
city: Bethesda
country: United States
facility: Centre for Cancer and Blood Disorders- Site Number : 8400026
state: Maryland
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Site Number : 8400006
state: Mississippi
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada- Site Number : 8400019
state: Nevada
city: Morristown
country: United States
facility: Atlantic Health System Site Number : 8400005
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.- Site Number : 8400017
state: New York
city: Charlotte
country: United States
facility: Novant Health- Site Number : 8400014
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center Site Number : 8400114
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Site Number : 8400027
state: Ohio
city: Cincinnati
country: United States
facility: Oncology_Hematology Care Clinical Trials, LLC- Site Number : 8400016
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates Of Oregon, P.C.- Site Number : 8400018
state: Oregon
city: Easton
country: United States
facility: Spoknwrd Clinical Trials Inc. Site Number : 8400023
state: Pennsylvania
city: Spartanburg
country: United States
facility: Gibbs Cancer Center-Spartanburg Medical Center- Site Number : 8400002
state: South Carolina
city: Dallas
country: United States
facility: Texas Oncology Baylor Sammons- Site Number : 8400022
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern- Site Number : 8400024
state: Texas
city: Kingwood
country: United States
facility: Lumi Research- Site Number : 8400029
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio- Site Number : 8400020
state: Texas
city: Salt Lake City
country: United States
facility: George E. Wahlen Salt Lake City VA Medical Center- Site Number : 8400011
state: Utah
city: Waukesha
country: United States
facility: UW Cancer Center at ProHealth Care Site Number : 8400001
state: Wisconsin
city: Caba
country: Argentina
facility: Investigational Site Number : 0320007
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320001
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
state: Buenos Aires
city: La Plata
country: Argentina
facility: Investigational Site Number : 0320006
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320003
state: Ciudad De Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320008
state: Ciudad De Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320005
state: Ciudad De Buenos Aires
city: Cordoba
country: Argentina
facility: Investigational Site Number : 0320010
state: Córdoba
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Mendoza
country: Argentina
facility: Investigational Site Number : 0320009
city: Liverpool
country: Australia
facility: Investigational Site Number : 0360007
state: New South Wales
city: Waratah
country: Australia
facility: Investigational Site Number : 0360004
state: New South Wales
city: Wollongong
country: Australia
facility: Investigational Site Number : 0360003
state: New South Wales
city: Adelaide
country: Australia
facility: Investigational Site Number : 0360008
state: South Australia
city: Fitzroy
country: Australia
facility: Investigational Site Number : 0360009
state: Victoria
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360006
state: Victoria
city: Richmond
country: Australia
facility: Investigational Site Number : 0360001
state: Victoria
city: Fortaleza
country: Brazil
facility: NOHC - Nucleo de Oncologia e Hematologia do Ceara- Site Number : 0760006
state: Ceará
city: Recife
country: Brazil
facility: OC ONCOCLINICAS MULTIHEMO ILHA DO LEITE Site Number : 0760007
state: Pernambuco
city: Niteroi
country: Brazil
facility: CHN - Complexo Hospitalar de Niteroi Site Number : 0760008
state: Rio De Janeiro
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus Site Number : 0760003
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Clínica São Germano- Site Number : 0760001
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Instituto COI de Educacao e Pesquisa- Site Number : 0760004
city: Toronto
country: Canada
facility: Investigational Site Number : 1240001
state: Ontario
city: Greenfield Park
country: Canada
facility: Investigational Site Number : 1240004
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number : 1240003
state: Quebec
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520006
state: Reg Metropolitana De Santiago
city: Viña del Mar
country: Chile
facility: Investigational Site Number : 1520005
state: Valparaíso
city: Santiago
country: Chile
facility: Investigational Site Number : 1520004
city: Temuco
country: Chile
facility: Investigational Site Number : 1520001
city: Beijing
country: China
facility: Investigational Site Number : 1560001
city: Beijing
country: China
facility: Investigational Site Number : 1560022
city: Changsha
country: China
facility: Investigational Site Number : 1560010
city: Guangzhou
country: China
facility: Investigational Site Number : 1560006
city: Hangzhou
country: China
facility: Investigational Site Number : 1560002
city: Nanchang
country: China
facility: Investigational Site Number : 1560020
city: Nanning
country: China
facility: Investigational Site Number : 1560019
city: Qingdao
country: China
facility: Investigational Site Number : 1560011
city: Shenyang
country: China
facility: Investigational Site Number : 1560013
city: Tianjin
country: China
facility: Investigational Site Number : 1560007
city: Tianjin
country: China
facility: Investigational Site Number : 1560009
city: Tianjin
country: China
facility: Investigational Site Number : 1560018
city: Wuhan
country: China
facility: Investigational Site Number : 1560003
city: Wuhan
country: China
facility: Investigational Site Number : 1560008
city: Zhengzhou
country: China
facility: Investigational Site Number : 1560004
city: Brno
country: Czechia
facility: Investigational Site Number : 2030005
city: Olomouc
country: Czechia
facility: Investigational Site Number : 2030003
city: Ostrava - Poruba
country: Czechia
facility: Investigational Site Number : 2030006
city: Praha 2
country: Czechia
facility: Investigational Site Number : 2030004
city: Nantes
country: France
facility: Investigational Site Number : 2500002
city: Paris
country: France
facility: Investigational Site Number : 2500005
city: Perigueux
country: France
facility: Investigational Site Number : 2500008
city: Poitiers
country: France
facility: Investigational Site Number : 2500001
city: Saint-Etienne Cedex 2
country: France
facility: Investigational Site Number : 2500009
city: TOULOUSE Cedex 9
country: France
facility: Investigational Site Number : 2500003
city: Tours
country: France
facility: Investigational Site Number : 2500007
city: Dresden
country: Germany
facility: Investigational Site Number : 2760005
city: Hamburg
country: Germany
facility: Investigational Site Number : 2760001
city: Heidelberg
country: Germany
facility: Investigational Site Number : 2760003
city: Lübeck
country: Germany
facility: Investigational Site Number : 2760006
city: Nürnberg
country: Germany
facility: Investigational Site Number : 2760007
city: Athens
country: Greece
facility: Investigational Site Number : 3000002
city: Athens
country: Greece
facility: Investigational Site Number : 3000001
city: Ioannina
country: Greece
facility: Investigational Site Number : 3000005
city: Patra
country: Greece
facility: Investigational Site Number : 3000003
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000004
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480002
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480004
city: Kaposvár
country: Hungary
facility: Investigational Site Number : 3480003
city: Pécs
country: Hungary
facility: Investigational Site Number : 3480008
city: Szekesfehervar
country: Hungary
facility: Investigational Site Number : 3480005
city: Szombathely
country: Hungary
facility: Investigational Site Number : 3480006
city: Meldola
country: Italy
facility: Investigational Site Number : 3800001
state: Forlì-Cesena
city: Rome
country: Italy
facility: Investigational Site Number : 3800006
state: Roma
city: Ancona
country: Italy
facility: Investigational Site Number : 3800004
city: Bologna
country: Italy
facility: Investigational Site Number : 3800002
city: Brescia
country: Italy
facility: Investigational Site Number : 3800005
city: Napoli
country: Italy
facility: Investigational Site Number : 3800007
city: Palermo
country: Italy
facility: Investigational Site Number : 3800008
city: Pavia
country: Italy
facility: Investigational Site Number : 3800003
city: Nagoya-shi
country: Japan
facility: Investigational Site Number : 3920001
state: Aichi
city: Kamogawa-shi
country: Japan
facility: Investigational Site Number : 3920007
state: Chiba
city: Higashiibaraki-gun
country: Japan
facility: Investigational Site Number : 3920005
state: Ibaraki
city: Shiwa-gun
country: Japan
facility: Investigational Site Number : 3920010
state: Iwate
city: Kamakura-shi
country: Japan
facility: Investigational Site Number : 3920012
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Investigational Site Number : 3920003
state: Kyoto
city: Natori-shi
country: Japan
facility: Investigational Site Number : 3920006
state: Miyagi
city: Okayama-shi
country: Japan
facility: Investigational Site Number : 3920002
state: Okayama
city: Osaka-shi
country: Japan
facility: Investigational Site Number : 3920011
state: Osaka
city: Sunto-gun
country: Japan
facility: Investigational Site Number : 3920008
state: Shizuoka
city: Shibuya-ku
country: Japan
facility: Investigational Site Number : 3920004
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Investigational Site Number : 3920009
city: Oslo
country: Norway
facility: Investigational Site Number : 5780001
city: Ålesund
country: Norway
facility: Investigational Site Number : 5780002
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6160004
state: Dolnoslaskie
city: Krakow
country: Poland
facility: Investigational Site Number : 6160005
state: Malopolskie
city: Lublin
country: Poland
facility: Investigational Site Number : 6160001
city: Santander
country: Spain
facility: Investigational Site Number : 7240003
state: Cantabria
city: Badalona
country: Spain
facility: Investigational Site Number : 7240004
state: Catalunya [Cataluña]
city: Madrid
country: Spain
facility: Investigational Site Number : 7240007
state: Madrid, Comunidad De
city: Pamplona
country: Spain
facility: Investigational Site Number : 7240001
state: Navarra
city: Madrid
country: Spain
facility: Investigational Site Number : 7240005
city: Murcia
country: Spain
facility: Investigational Site Number : 7240006
city: Salamanca
country: Spain
facility: Investigational Site Number : 7240002
city: Borås
country: Sweden
facility: Investigational Site Number : 7520001
city: Stockholm
country: Sweden
facility: Investigational Site Number : 7520003
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number : 1580001
city: Tainan
country: Taiwan
facility: Investigational Site Number : 1580005
city: Taipei
country: Taiwan
facility: Investigational Site Number : 1580002
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920007
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920009
city: Bornova
country: Turkey
facility: Investigational Site Number : 7920004
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920003
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920005
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920008
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920001
city: Leicester
country: United Kingdom
facility: Investigational Site Number : 8260002
state: Leicestershire
city: London
country: United Kingdom
facility: Investigational Site Number : 8260005
state: London, City Of
city: Norwich
country: United Kingdom
facility: Investigational Site Number : 8260001
state: Norfolk
city: Birmingham
country: United Kingdom
facility: Investigational Site Number : 8260004
city: Derby
country: United Kingdom
facility: Investigational Site Number : 8260003
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: