Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
NCT ID: NCT02990338
Last Updated: 2025-01-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
307 participants
INTERVENTIONAL
2016-12-22
2023-11-01
Brief Summary
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To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM).
Secondary Objectives:
* To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm.
* To compare the Overall Survival (OS) between the two arms.
* To evaluate the Time To Progression (TTP) in each arm.
* To evaluate the PFS in high risk cytogenetic population in each arm.
* To evaluate the Duration of Response (DOR) in each arm.
* To evaluate the safety in both treatment arms.
* To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.
* To evaluate the immunogenicity of isatuximab.
* To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.
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Detailed Description
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During follow-up, participants who discontinued the study treatment due to progression of the disease were followed every 3 months (12 weeks) for survival (or until cut-off date), and participants who discontinued the study treatment prior to documentation of disease progression were followed-up every 4 weeks until disease progression, and then every 3 months (12 weeks) for survival (or until cut-off date).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pd (pomalidomide + dexamethasone)
Participants received pomalidomide 4 milligrams (mg) Per os (PO) on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants greater than or equal to (\>=) 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 306.6 weeks).
Pomalidomide
Pharmaceutical form: capsule Route of administration: oral
Dexamethasone
Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous
IPd (isatuximab + pomalidomide + dexamethasone)
Participants received isatuximab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 311.0 weeks).
Isatuximab
Pharmaceutical form: solution for infusion Route of administration: intravenous
Pomalidomide
Pharmaceutical form: capsule Route of administration: oral
Dexamethasone
Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous
Interventions
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Isatuximab
Pharmaceutical form: solution for infusion Route of administration: intravenous
Pomalidomide
Pharmaceutical form: capsule Route of administration: oral
Dexamethasone
Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants had a documented diagnosis of multiple myeloma with evidence of measurable disease i.e. serum M protein superior or equal to 0.5 grams per decilitre (g/dL) measured using serum protein immunoelectrophoresis and or urine M protein superior or equal to 200 mg per 24 hours measured using urine protein immunoelectrophoresis.
* Participants had received at least 2 prior lines of anti-myeloma therapy, which must include at least 2 consecutive cycles of lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination.
* Participants had failed treatment with lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib, or ixazomib) alone or in combination (Intolerant, progression within 6 months after reaching Partial Response or better).
* Participants had progressed on or within 60 days after end of previous therapy before to study entry, i.e., refractory to the last line of treatment.
Exclusion Criteria
* Free Light Chain measurable disease only.
* Prior therapy with pomalidomide.
* Any anti-myeloma drug treatment within 14 days before randomization, including dexamethasone.
* Eastern Cooperative Oncology Group performance status superior to 2.
* Platelets inferior to 75 000 cells per microliter (mcL) if inferior to 50% of bone marrow (BM) nucleated cells are plasma cells, and inferior to 30 000 cells per mcL if superior or equal to 50% of BM nucleated cells are plasma cells. Platelet transfusion was not allowed within three days before the screening visit.
* Absolute neutrophil count inferior to 1000 per mcL (1\*10\^9/L).
* Creatinine clearance inferior to 30 mL per minute (Modification of Diet in Renal Disease \[MDRD\] Formula).
* Total bilirubin superior to 2\*ULN (Upper Limit of Normal).
* Corrected serum calcium superior to 14 milligrams per deciliter (mg/dL) (superior to 3.5 millimoles per liter (mmol/L).
* Aspartate aminotransferase (AST) and/or Alanine Aminotransferase (ALT) superior to 3\*ULN.
* Hypersensitivity to immunomodulatory drugs (IMiDs) (thalidomide or lenalidomide) defined as any hypersensitivity reaction leading to stop IMiDs within the 2 first cycles or toxicity, which does meet intolerance definition.
* Hypersensitivity to dexamethasone, sucrose histidine (as base and hydrochloride salt), and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids, or H2 blockers that would prohibit further treatment with these agents.
* Significant cardiac dysfunction; myocardial infarction within 12 months; unstable, poorly controlled angina pectoris.
* Pregnant or breastfeeding woman or female who intends to become pregnant during the participation in the study.
* Male participants who disagreed to practice true abstinence or disagreed to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and at least 3 or 5 months following study treatment discontinuation, even if he had undergone a successful vasectomy.
* All participants who disagreed to refrain from donating blood while on study treatment and for 4 weeks after discontinuation from this study treatment.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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BRCR Medical Center Inc. Site Number : 8400002
Plantation, Florida, United States
Dana Farber Site Number : 8400006
Boston, Massachusetts, United States
Investigational Site Number : 0360004
St Leonards, New South Wales, Australia
Investigational Site Number : 0360001
Waratah, New South Wales, Australia
Investigational Site Number : 0360005
Melbourne, Victoria, Australia
Investigational Site Number : 0360002
Melbourne, Victoria, Australia
Investigational Site Number : 0360006
Richmond, Victoria, Australia
Investigational Site Number : 0560003
Antwerp, , Belgium
Investigational Site Number : 0560002
Brussels, , Belgium
Investigational Site Number : 0560004
Ghent, , Belgium
Investigational Site Number : 0560001
Leuven, , Belgium
Investigational Site Number : 1240001
Montreal, Quebec, Canada
Investigational Site Number : 1240004
Montreal, Quebec, Canada
Investigational Site Number : 1240005
Sherbrooke, Quebec, Canada
Investigational Site Number : 2030005
Brno, , Czechia
Investigational Site Number : 2030004
Hradec Králové, , Czechia
Investigational Site Number : 2030001
Olomouc, , Czechia
Investigational Site Number : 2030002
Ostrava - Poruba, , Czechia
Investigational Site Number : 2030003
Prague, , Czechia
Investigational Site Number : 2080002
Aalborg, , Denmark
Investigational Site Number : 2500021
Bayonne, , France
Investigational Site Number : 2500008
Caen, , France
Investigational Site Number : 2500009
Dijon, , France
Investigational Site Number : 2500017
Grenoble, , France
Investigational Site Number : 2500013
La Roche-sur-Yon, , France
Investigational Site Number : 2500003
Lille, , France
Investigational Site Number : 2500023
Limoges, , France
Investigational Site Number : 2500019
Montpellier, , France
Investigational Site Number : 2500002
Nantes, , France
Investigational Site Number : 2500015
Paris, , France
Investigational Site Number : 2500016
Paris, , France
Investigational Site Number : 2500005
Pessac, , France
Investigational Site Number : 2500004
Pierre-Bénite, , France
Investigational Site Number : 2500007
Poitiers, , France
Investigational Site Number : 2500025
Reims, , France
Investigational Site Number : 2500014
Rennes, , France
Investigational Site Number : 2500001
Toulouse, , France
Investigational Site Number : 2500012
Tours, , France
Investigational Site Number : 2500018
Vandœuvre-lès-Nancy, , France
Investigational Site Number : 2760001
Leipzig, , Germany
Investigational Site Number : 3000002
Athens, , Greece
Investigational Site Number : 3000005
Athens, , Greece
Investigational Site Number : 3000001
Athens, , Greece
Investigational Site Number : 3000004
Pátrai, , Greece
Investigational Site Number : 3000003
Thessaloniki, , Greece
Investigational Site Number : 3480001
Budapest, , Hungary
Investigational Site Number : 3480003
Budapest, , Hungary
Investigational Site Number : 3480002
Debrecen, , Hungary
Investigational Site Number : 3800001
Bologna, , Italy
Investigational Site Number : 3800010
Catania, , Italy
Investigational Site Number : 3800009
Florence, , Italy
Investigational Site Number : 3800008
Genova, , Italy
Investigational Site Number : 3800007
Milan, , Italy
Investigational Site Number : 3800002
Milan, , Italy
Investigational Site Number : 3800006
Padua, , Italy
Investigational Site Number : 3800004
Terni, , Italy
Investigational Site Number : 3800003
Torino, , Italy
Investigational Site Number : 3920001
Nagoya, Aichi-ken, Japan
Investigational Site Number : 3920005
Shibukawa-shi, Gunma, Japan
Investigational Site Number : 3920004
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920006
Kyoto, Kyoto, Japan
Investigational Site Number : 3920008
Suwa-shi, Nagano, Japan
Investigational Site Number : 3920003
Okayama, Okayama-ken, Japan
Investigational Site Number : 3920007
Sunto-gun, Shizuoka, Japan
Investigational Site Number : 3920002
Shibuya-ku, Tokyo, Japan
Investigational Site Number : 5540001
Takapuna, Auckland, New Zealand
Investigational Site Number : 5540004
Dunedin, Otago, New Zealand
Investigational Site Number : 5540003
Hamilton, Waikato Region, New Zealand
Investigational Site Number : 5540002
Auckland, , New Zealand
Investigational Site Number : 5780001
Oslo, , Norway
Investigational Site Number : 6160005
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160003
Lublin, Lubusz Voivodeship, Poland
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160002
Chorzów, Silesian Voivodeship, Poland
Investigational Site Number : 6200004
Coimbra, , Portugal
Investigational Site Number : 6200002
Lisbon, , Portugal
Investigational Site Number : 6200001
Porto, , Portugal
Investigational Site Number : 6430004
Moscow, , Russia
Investigational Site Number : 6430001
Moscow, , Russia
Investigational Site Number : 6430002
Moscow, , Russia
Investigational Site Number : 7030001
Bratislava, , Slovakia
Investigational Site Number : 4100007
Hwasun-gun, Jeollanam-do, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100006
Incheon, , South Korea
Investigational Site Number : 4100005
Seoul, , South Korea
Investigational Site Number : 7240005
Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006
Santander, Cantabria, Spain
Investigational Site Number : 7240002
Pamplona, Navarre, Spain
Investigational Site Number : 7240003
Madrid, , Spain
Investigational Site Number : 7240004
Salamanca, , Spain
Investigational Site Number : 7520004
Luleå, , Sweden
Investigational Site Number : 7520005
Uddevalla, , Sweden
Investigational Site Number : 1580004
Kaohsiung City, , Taiwan
Investigational Site Number : 1580002
Taichung, , Taiwan
Investigational Site Number : 1580001
Taipei, , Taiwan
Investigational Site Number : 1580003
Taoyuan District, , Taiwan
Investigational Site Number : 7920001
Ankara, , Turkey (Türkiye)
Investigational Site Number : 7920002
Antalya, , Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920006
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920003
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920004
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920008
Izmir, , Turkey (Türkiye)
Investigational Site Number : 7920010
Izmir, , Turkey (Türkiye)
Investigational Site Number : 7920009
Kayseri, , Turkey (Türkiye)
Investigational Site Number : 7920007
Kocaeli, , Turkey (Türkiye)
Investigational Site Number : 8260002
London, London, City of, United Kingdom
Investigational Site Number : 8260003
London, London, City of, United Kingdom
Investigational Site Number : 8260001
London, London, City of, United Kingdom
Countries
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References
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Beksac M, Spicka I, Hajek R, Bringhen S, Jelinek T, Martin T, Mikala G, Moreau P, Symeonidis A, Rawlings AM, van de Velde H, Richardson PG. Evaluation of isatuximab in patients with soft-tissue plasmacytomas: An analysis from ICARIA-MM and IKEMA. Leuk Res. 2022 Nov;122:106948. doi: 10.1016/j.leukres.2022.106948. Epub 2022 Sep 6.
Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Mace S, Corzo KP, Campana F, Le-Guennec S, Dubin F, Anderson KC; ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019 Dec 7;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14.
Richardson PG, Perrot A, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Malinge L, Dubin F, van de Velde H, Anderson KC. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study. Lancet Oncol. 2022 Mar;23(3):416-427. doi: 10.1016/S1470-2045(22)00019-5. Epub 2022 Feb 10.
Richardson PG, Perrot A, Miguel JS, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang SY, Minarik J, Cavo M, Prince HM, Mace S, Zhang R, Dubin F, Morisse MC, Anderson KC. Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: final overall survival analysis. Haematologica. 2024 Jul 1;109(7):2239-2249. doi: 10.3324/haematol.2023.284325.
Sunami K, Ikeda T, Huang SY, Wang MC, Koh Y, Min CK, Yeh SP, Matsumoto M, Uchiyama M, Iyama S, Shimazaki C, Lee JH, Kim K, Kaneko H, Kim JS, Lin TL, Campana F, Tada K, Iida S, Suzuki K; ICARIA-MM study group. Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis. Clin Lymphoma Myeloma Leuk. 2022 Aug;22(8):e751-e761. doi: 10.1016/j.clml.2022.04.005. Epub 2022 Apr 8.
Wilmoth J, Colson K, Dubin F, Kellam C. Isatuximab: Nursing Considerations for Use in the Treatment of Multiple Myeloma. Clin J Oncol Nurs. 2021 Dec 1;25(6):706-712. doi: 10.1188/21.CJON.706-712.
Bringhen S, Pour L, Vorobyev V, Vural F, Warzocha K, Benboubker L, Koh Y, Maisnar V, Karlin L, Pavic M, Campana F, Le Guennec S, Menas F, van de Velde H, Richardson PG. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma according to prior lines of treatment and refractory status: ICARIA-MM subgroup analysis. Leuk Res. 2021 May;104:106576. doi: 10.1016/j.leukres.2021.106576. Epub 2021 Mar 29.
Schjesvold FH, Richardson PG, Facon T, Alegre A, Spencer A, Jurczyszyn A, Sunami K, Frenzel L, Min CK, Guillonneau S, Lin PL, Le-Guennec S, Campana F, van de Velde H, Bensfia S, Bringhen S. Isatuximab plus pomalidomide and dexamethasone in elderly patients with relapsed/refractory multiple myeloma: ICARIA-MM subgroup analysis. Haematologica. 2021 Apr 1;106(4):1182-1187. doi: 10.3324/haematol.2020.253450. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1180-6262
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-003097-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC14335
Identifier Type: -
Identifier Source: org_study_id
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