A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (SubQSA)

February 20, 2026 updated by: Sanofi

A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The duration of the study for a participant will include a period for screening of up to 28 days, a study treatment period of 12 months (except early discontinuation), the end-of-treatment (EOT) visit about 30 days after the last dose of study treatment, and a study follow-up period until death or the final study cut-off date. A cycle duration is 28 days. After study treatment discontinuation, participants will return to the study site 30 days after the last dose of study treatment for the EOT visit or before further anti-myeloma therapy initiation, whichever comes first.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: contact-us@sanofi.com

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic in Arizona - Phoenix- Site Number : 8400058
    • California
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Los Angeles Hematology Oncology Medical Group- Site Number : 8400027
      • West Hollywood, California, United States, 90069
        • Recruiting
        • Private Practice - Dr. James R. Berenson- Site Number : 8400044
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Smilow Cancer Center at Yale-New Haven- Site Number : 8400020
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20017
        • Recruiting
        • Maryland Oncology Hematology- Site Number : 8400038
    • Florida
      • Coral Springs, Florida, United States, 33071
        • Recruiting
        • Life Clinical Trials - Coral Springs- Site Number : 8400055
      • Fort Lauderdale, Florida, United States, 33309
        • Recruiting
        • Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida- Site Number : 8400002
      • Lakeland, Florida, United States, 33812
        • Recruiting
        • The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054
      • Margate, Florida, United States, 33063
        • Recruiting
        • D&H Pompano Research Center- Site Number : 8400049
      • Pembroke Pines, Florida, United States, 33024
        • Recruiting
        • Millennium Oncology - Pembroke Pines- Site Number : 8400011
      • Plantation, Florida, United States, 33322
        • Recruiting
        • BRCR Global- Site Number : 8400008
      • St. Petersburg, Florida, United States, 33705
        • Recruiting
        • Florida Cancer Specialists - North- Site Number : 8400030
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Pontchartrain Cancer Center - Covington- Site Number : 8400046
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center - Boston- Site Number : 8400005
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Hematology Oncology Consultants - Royal Oak- Site Number : 8400039
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Recruiting
        • Alliance for Multispeciality Research - Kansas City- Site Number : 8400056
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University- Site Number : 8400007
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • Recruiting
        • San Juan Oncology Associates- Site Number : 8400016
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center- Site Number : 8400018
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center- Site Number : 8400010
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center- Site Number : 8400043
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Oncology Hematology Care - Kenwood- Site Number : 8400014
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Recruiting
        • Roper Saint Francis Healthcare- Site Number : 8400013
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute - Greenville- Site Number : 8400019
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Gibbs Cancer Center & Research Institute - Spartanburg- Site Number : 8400001
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center- Site Number : 8400006
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road- Site Number : 8400035
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology Nashville- Site Number : 8400012
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Northern Virginia Oncology Group- Site Number : 8400045
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • SSM Health Dean Medical Group - Wisconsin - Madison- Site Number : 8400009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have a documented diagnosis of MM.

  • Participants with measurable disease defined as at least one of the following:

    • Serum M-protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or
    • Urine M-protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or
    • Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
  • Participants with relapsed and/or refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy.

  • Contraceptive use by [men and women] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    • Male participants agree to practice true abstinence or agree to use contraception while receiving study treatment, during dose interruptions and at least 5 months following study treatment discontinuation, even if has undergone a successful vasectomy.
    • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP XE " FCBP " \f Abbreviation \t "female of childbearing potential" ) or agrees to practice complete abstinence or use contraception.
  • Capable of giving signed informed consent.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Primary refractory MM defined as participants who have never achieved at least a minimal response (MR) with any treatment during the disease course.
  • Participants with prior anti-CD38 treatment if: a) administered < 6 months before first isatuximab administration or, b) intolerant to the anti-CD38 previously received.
  • Participants who are refractory to carfilzomib.
  • Known history of allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib), prior hypersensitivity to sucrose, histidine (as base and hydrochloride salt), polysorbate 80, or any of the components (active substance or excipient) of study treatment that are not amenable to premedication with steroids, or intolerance to arginine and Poloxamer 188 that would prohibit further treatment with these agents.
  • Participants with contraindication to dexamethasone and/or to carfilzomib.
  • Any anti-myeloma drug treatment within 14 days before the first isatuximab administration, including dexamethasone.
  • Prior allogenic HSC transplant with active graft versus host disease (GvHD XE " GvHD " \f Abbreviation \t "graft versus host disease" ) (GvHD any grade and/or being under immunosuppressive treatment within the last 2 months).
  • Any major procedure within 14 days before the first isatuximab administration: plasmapheresis, major surgery (kyphoplasty is not considered a major procedure), radiotherapy.
  • Vaccination with a live vaccine within 4 weeks before the first isatuximab administration. Seasonal flu vaccines that do not contain live virus are permitted.
  • Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Isatuximab in combination with weekly carfilzomib and dexamethasone
Participants will receive isatuximab via SC-OBDS administration in combination with weekly carfilzomib and dexamethasone. Isatuximab will be administered on days 1, 8, 15 and 22 for Cycle 1 and then on days 1, 15 for subsequent cycles. Carfilzomib will be administered intravenously (IV) at a starting dose on Day 1 of Cycle 1 and then escalated dose on Days 8 and 15 of Cycle 1, followed by Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be given on Days 1, 8, 15, and 22 of Cycle 1 and then on Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be administered IV on Cycle 1 Day 1, and IV or PO in the subsequent administrations. 1 cycle = 28 days.
Drug: Isatuximab SC-OBDS
Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS
Other Names:
  • SAR650984
  • Sarclisa
Drug: Montelukast
Pharmaceutical form:As per local commercial product-Route of administration:Oral
Drug: Dexamethasone
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
Drug: Acetaminophen
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
Drug: Diphenhydramine
Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)
Drug: Methylprednisolone
Pharmaceutical form:As per local commercial product-Route of administration:IV
Drug: Carfilzomib
Pharmaceutical form:As per local commercial product-Route of administration:IV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 6 months after the Last Participant In (LPI) i.e., approximately 32 months
ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to IMWG criteria assessed by investigator.
6 months after the Last Participant In (LPI) i.e., approximately 32 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with infusion reactions (IRs)
Time Frame: From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable)
Time Frame: From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
Number of participants with injection site reactions (ISRs)
Time Frame: From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
CR or better
Time Frame: 12 months after the Last Participant In (LPI) i.e., approximately 38 months
CR or better assessed according to International Myeloma Working Group (IMWG) criteria assessed by investigator. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates, and a normal FLC ratio of 0.26-1.65 is required for FLC disease only. Two consecutive assessments are needed. No known evidence of progressive disease or new bone/soft tissue lesions if radiographic studies were performed.
12 months after the Last Participant In (LPI) i.e., approximately 38 months
VGPR or better
Time Frame: 12 months after the Last Participant In (LPI) i.e., approximately 38 months
VGPR or better assessed according to IMWG criteria assessed by investigator. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h, or ≥90% decrease in the sum of maximal perpendicular diameter compared to baseline in soft tissue plasmacytoma. FLC only: a ≥90% decrease in the difference between involved and uninvolved FLC levels. Two consecutive assessments are needed. No known evidence of progressive disease or new bone/soft tissue lesions if radiographic studies were performed.
12 months after the Last Participant In (LPI) i.e., approximately 38 months
Duration of response (DOR)
Time Frame: 12 months after the Last Participant In (LPI) i.e., approximately 38 months
DOR, defined as the time from date of first investigator determined response for achieving PR or better to first documentation of progressive disease (PD) determined by investigator or death, whichever occurred first.
12 months after the Last Participant In (LPI) i.e., approximately 38 months
Time to first response (TT1R)
Time Frame: 12 months after the Last Participant In (LPI) i.e., approximately 38 months
TT1R, defined as the time from first isatuximab administration to first investigator-determined response (PR or better) that is subsequently confirmed.
12 months after the Last Participant In (LPI) i.e., approximately 38 months
Time to best response (TTBR)
Time Frame: 12 months after the Last Participant In (LPI) i.e., approximately 38 months
TTBR, defined as the time from first isatuximab administration to first occurrence of investigator-determined best response (PR or better) that is subsequently confirmed.
12 months after the Last Participant In (LPI) i.e., approximately 38 months
Patient experience and Satisfaction Questionnaire v2 (PESQ v2)
Time Frame: Cycle 3/Day 15 and Cycle 6/Day 15
The PESQ v2 has been designed to follow up on participant experience and satisfaction regarding the treatment (side effects and recommendation) and the administration method (comfortability, pain, side effects and overall satisfaction). This questionnaire has been developed using industry standard for instrument development and has been debriefed and adapted based on qualitative interviews with oncology patients. The more general treatment expectations instrument (v1) was further adapted and debriefed with patients to assess manual and OBDS subcutaneous delivery (v2). The trial specific version of the PESQ v2 contains of items administered for the duration of treatment. Response options are presented as a 5-point Likert scale ranging from Strongly agree/very satisfied/definitely yes to strongly disagree/very dissatisfied/definitely no.
Cycle 3/Day 15 and Cycle 6/Day 15
Positivity titer of anti-drug antibodies (ADA) in a subset of approximately 30 participants
Time Frame: From Cycle 1 Day 1 to follow-up (90 days from last administration) i.e, approximately up to 15 months (1 cycle = 28 days)
Blood samples will be collected for assessing the presence of ADA against isatuximab in plasma from approximately 30 participants. Plasma samples will be screened for antibodies binding to isatuximab and the titer of confirmed positive samples will be reported.
From Cycle 1 Day 1 to follow-up (90 days from last administration) i.e, approximately up to 15 months (1 cycle = 28 days)
Maximum observed concentration (Cmax) of isatuximab in a subset of approximately 30 participants
Time Frame: Multiple timepoints in Cycle 1 (1 cycle = 28 days)
Multiple timepoints in Cycle 1 (1 cycle = 28 days)
Cumulative area under the curve over the first 4 weeks of isatuximab treatment (AUC4 weeks) in a subset of approximately 30 participants
Time Frame: Multiple timepoints in Cycle 1 (1 cycle = 28 days)
Multiple timepoints in Cycle 1 (1 cycle = 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LPS18183
  • U1111-1298-7348 (Other Identifier: WHO ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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