Multiple Myeloma Clinical Trial

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients

Summary

Primary Objective:

To demonstrate the benefit of treatment-a-promising-new-option-for-relapsed-multiple-myeloma/" >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.

View Full Description

Full Description

The duration of the study for the participants included a period for screening of up to 21 days (or up to 28 days for women who can become pregnant). Participants continued study treatment until disease progression, unacceptable adverse reaction, participants' wish or other reason of discontinuation.

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria :

Age superior or equal to 18 years or country's legal age of majority if the legal age was superior to 18 years old.
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:

Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.
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 x 10^9/L).
Creatinine clearance inferior to 30 mL per minute (Modification of Diet in Renal Disease [MDRD] Formula).
Total bilirubin superior to 2 x 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 x 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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

307

Study ID:

NCT02990338

Recruitment Status:

Active, not recruiting

Sponsor:

Sanofi

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There are 106 Locations for this study

See Locations Near You

Investigational Site Number :8400002
Plantation Florida, 33324, United States
Investigational Site Number :8400006
Boston Massachusetts, 02215, United States
Investigational Site Number :0360004
St Leonards New South Wales, 2065, Australia
Investigational Site Number :0360001
Waratah New South Wales, 2298, Australia
Investigational Site Number :0360005
Melbourne Victoria, 3000, Australia
Investigational Site Number :0360002
Melbourne Victoria, 3004, Australia
Investigational Site Number :0360006
Richmond Victoria, 3121, Australia
Investigational Site Number :0560003
Antwerpen , 2060, Belgium
Investigational Site Number :0560002
Brussel , 1090, Belgium
Investigational Site Number :0560004
Gent , 9000, Belgium
Investigational Site Number :0560001
Leuven , 3000, Belgium
Investigational Site Number :1240001
Montreal Quebec, H1T 2, Canada
Investigational Site Number :1240004
Montreal Quebec, H4A 3, Canada
Investigational Site Number :1240005
Sherbrooke Quebec, J1H 5, Canada
Investigational Site Number :2030005
Brno , 62500, Czechia
Investigational Site Number :2030004
Hradec Kralove , 50005, Czechia
Investigational Site Number :2030001
Olomouc , 77900, Czechia
Investigational Site Number :2030002
Ostrava - Poruba , 70852, Czechia
Investigational Site Number :2030003
Praha 2 , 12808, Czechia
Investigational Site Number :2080002
Ålborg , 9100, Denmark
Investigational Site Number :2500021
Bayonne , 64100, France
Investigational Site Number :2500008
Caen , 14033, France
Investigational Site Number :2500009
Dijon , 21000, France
Investigational Site Number :2500017
Grenoble , 38043, France
Investigational Site Number :2500013
La Roche Sur Yon , 85925, France
Investigational Site Number :2500003
Lille , 59037, France
Investigational Site Number :2500023
Limoges , 87042, France
Investigational Site Number :2500019
Montpellier Cedex , 34295, France
Investigational Site Number :2500002
Nantes , 44093, France
Investigational Site Number :2500015
Paris , 75005, France
Investigational Site Number :2500016
Paris , 75743, France
Investigational Site Number :2500005
Pessac , 33600, France
Investigational Site Number :2500004
Pierre Benite , 69495, France
Investigational Site Number :2500007
POITIERS Cedex , 86021, France
Investigational Site Number :2500025
Reims , 51092, France
Investigational Site Number :2500014
Rennes , 35033, France
Investigational Site Number :2500001
TOULOUSE Cedex 9 , 31059, France
Investigational Site Number :2500012
Tours , 37044, France
Investigational Site Number :2500018
Vandoeuvre-les-nancy , 54511, France
Investigational Site Number :2760001
Leipzig , 04103, Germany
Investigational Site Number :3000002
Athens , 106 7, Greece
Investigational Site Number :3000005
Athens , 11527, Greece
Investigational Site Number :3000001
Athens , 11528, Greece
Investigational Site Number :3000004
Patra , 26504, Greece
Investigational Site Number :3000003
Thessaloniki , 57010, Greece
Investigational Site Number :3480001
Budapest , 1083, Hungary
Investigational Site Number :3480003
Budapest , 1097, Hungary
Investigational Site Number :3480002
Debrecen , 4032, Hungary
Investigational Site Number :3800001
Bologna , 40138, Italy
Investigational Site Number :3800010
Catania , 95123, Italy
Investigational Site Number :3800009
Firenze , 50134, Italy
Investigational Site Number :3800008
Genova , 16132, Italy
Investigational Site Number :3800007
Milano , 20132, Italy
Investigational Site Number :3800002
Milano , 20133, Italy
Investigational Site Number :3800006
Padova , 35128, Italy
Investigational Site Number :3800004
Terni , 05100, Italy
Investigational Site Number :3800003
Torino , 10126, Italy
Investigational Site Number :3920001
Nagoya-shi Aichi, 467-8, Japan
Investigational Site Number :3920005
Shibukawa-shi Gunma, 377-0, Japan
Investigational Site Number :3920004
Sapporo-shi Hokkaido, 060-8, Japan
Investigational Site Number :3920006
Kyoto-shi Kyoto, 603-8, Japan
Investigational Site Number :3920008
Suwa-shi Nagano, 392-8, Japan
Investigational Site Number :3920003
Okayama-shi Okayama, 701-1, Japan
Investigational Site Number :3920007
Sunto-gun Shizuoka, 411-8, Japan
Investigational Site Number :3920002
Shibuya-ku Tokyo, 150-8, Japan
Investigational Site Number :4100007
Hwasun-gun Jeollanam-do, 58128, Korea, Republic of
Investigational Site Number :4100001
Seoul Seoul-teukbyeolsi, 03080, Korea, Republic of
Investigational Site Number :4100002
Seoul Seoul-teukbyeolsi, 06351, Korea, Republic of
Investigational Site Number :4100006
Incheon , 21565, Korea, Republic of
Investigational Site Number :4100005
Seoul , 06591, Korea, Republic of
Investigational Site Number :5540001
Takapuna Auckland, 1309, New Zealand
Investigational Site Number :5540004
Dunedin Otago, 9016, New Zealand
Investigational Site Number :5540003
Hamilton Waikato, 3204, New Zealand
Investigational Site Number :5540002
Auckland , 2025, New Zealand
Investigational Site Number :5780001
Oslo , 0450, Norway
Investigational Site Number :6160003
Lublin Lubuskie, 20-08, Poland
Investigational Site Number :6160005
Krakow Malopolskie, 31-50, Poland
Investigational Site Number :6160001
Warszawa Mazowieckie, 02-77, Poland
Investigational Site Number :6160002
Chorzow Slaskie, 41-50, Poland
Investigational Site Number :6200004
Coimbra , 3000-, Portugal
Investigational Site Number :6200002
Lisboa , 1070, Portugal
Investigational Site Number :6200001
Porto , 4200, Portugal
Investigational Site Number :6430004
Moscow , 12516, Russian Federation
Investigational Site Number :6430001
Moscow , 12528, Russian Federation
Investigational Site Number :6430002
Moscow , 12930, Russian Federation
Investigational Site Number :7030001
Bratislava , 83310, Slovakia
Investigational Site Number :7240005
Santiago de Compostela A Coruña [La Coruña], 15706, Spain
Investigational Site Number :7240001
Barcelona Barcelona [Barcelona], 08035, Spain
Investigational Site Number :7240006
Santander Cantabria, 39008, Spain
Investigational Site Number :7240002
Pamplona Navarra, 31008, Spain
Investigational Site Number :7240003
Madrid , 28006, Spain
Investigational Site Number :7240004
Salamanca , 37007, Spain
Investigational Site Number :7520004
Luleå , 97180, Sweden
Investigational Site Number :7520005
Uddevalla , 451 8, Sweden
Investigational Site Number :1580004
Kaohsiung , 833, Taiwan
Investigational Site Number :1580002
Taichung , 40447, Taiwan
Investigational Site Number :1580001
Taipei , 100, Taiwan
Investigational Site Number :1580003
Taoyuan , 333, Taiwan
Investigational Site Number :7920001
Ankara , , Turkey
Investigational Site Number :7920002
Antalya , , Turkey
Investigational Site Number :7920005
Istanbul , 34010, Turkey
Investigational Site Number :7920006
Istanbul , 34381, Turkey
Investigational Site Number :7920003
Istanbul , 34390, Turkey
Investigational Site Number :7920004
Istanbul , , Turkey
Investigational Site Number :7920008
Izmir , 35040, Turkey
Investigational Site Number :7920010
Izmir , 35340, Turkey
Investigational Site Number :7920009
Kayseri , 38039, Turkey
Investigational Site Number :7920007
Kocaeli , 41400, Turkey
Investigational Site Number :8260002
London , EC1A , United Kingdom
Investigational Site Number :8260003
London , SE1 9, United Kingdom
Investigational Site Number :8260001
London , WC1E6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

307

Study ID:

NCT02990338

Recruitment Status:

Active, not recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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