A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma

Study Purpose

Primary Objectives:

  • - Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) - Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM.
Secondary Objectives: Safety run-in.
  • - To assess overall response rate (ORR) - To assess duration of response (DOR) - To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) - To assess time to diagnostic (SLiM CRAB) progression or death.
  • - To assess time to first-line treatment for multiple myeloma (MM) - To assess the potential immunogenicity of isatuximab.
  • - Impact of abnormal cytogenetic subtype.
Randomized Phase 3
  • - Key Secondary Objectives: To compare between the arms.
  • - MRD negativity.
  • - Sustained MRD negativity.
  • - Second progression-free survival (PFS2) - Overall survival.
Other Secondary Objectives: To evaluate in both arms.
  • - CR rate.
  • - ORR.
  • - DOR.
  • - Time to diagnostic (SLiM CRAB) progression.
  • - Time to first-line treatment for MM.
  • - Safety and tolerability.
  • - Pharmacokinetics (PK) - Potential of isatuximab immunogenicity.
- Clinical outcome assessments (COAs)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria:

  • - Participants who are diagnosed within 5 years with SMM (per International Myeloma Working Group [IMWG] criteria), defined as serum M-protein ≥30 g/L or urinary M-protein ≥500 mg per 24 hour or both, and/or clonal bone marrow plasma cells (BMPCs) 10% to <60%, and absence of myeloma defining events or other related conditions and with high-risk SMM.
  • - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or 2.
  • - Capable of giving voluntary written informed consent.

Exclusion criteria:

  • - Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): - Increased calcium levels: Corrected serum calcium >1 mg/dL above the ULN or >11 mg/dL.
  • - Renal insufficiency: Determined by glomerular filtration rate (GFR) <40 mL/min/1.73 m² (Modification of Diet in Renal Disease [MDRD] Formula) or serum creatinine >2 mg/dL.
  • - Anemia (hemoglobin 2 g/dL below lower limit of normal or <10 g/dL or both) transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted.
  • - ≥ 1 bone lytic lesion.
  • - BMPCs ≥60% - Serum involved/uninvolved FLC ratio ≥100 and an involved FLC ≥100mg/L.
  • - Whole body magnetic resonance imaging (WB-MRI) or positron emission tomography-computed tomography (PET-CT) with more than 1 bone focal lesion (≥5 mm in diameter by MRI) - Primary systemic amyloid light-chain (immunoglobulin light chain) amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), standard risk smoldering myeloma, soft tissue plasmacytoma, symptomatic myeloma.
  • - Uncontrolled infection within 28 days prior to randomization in Phase 3 or first study intervention administration in safety run-in.
  • - Clinically significant cardiac disease, including: - Myocardial infarction within 6 months with left ventricular dysfunction or uncontrolled ischemic cardiac disease before Cycle 1 Day 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV) - Uncontrolled cardiac arrhythmia (Grade 2 or higher by NCI-CTCAE Version 5.0) or clinically significant electrocardiogram (ECG) abnormalities.
  • - Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A (defined as positive hepatitis A antigen or positive IgM).
HIV serology at screening will be tested for German participants and any other country where required as per local regulations and serology hepatitis B and C at screening will be tested for all participants.
  • - Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV DNA.
Of note: Patient can be eligible if anti-HBc IgG positive (with or without positive anti-HBs) but HBsAg and HBV DNA are negative. If anti-HBV therapy in relation with prior infection was started before initiation of IMP, the anti-HBV therapy and monitoring should continue throughout the study treatment period. Patients with negative HBsAg and positive HBV DNA observed during screening period will be evaluated by a specialist for start of anti-viral treatment: study treatment could be proposed if HBV DNA becomes negative and all the other study criteria are still met. Active HCV infection: positive HCV RNA and negative anti-HCV. Of note: Patients with antiviral therapy for HCV started before initiation of IMP and positive HCV antibodies are eligible. The antiviral therapy for HCV should continue throughout the treatment period until seroconversion. Patients with positive anti-HCV and undetectable HCV RNA without antiviral therapy for HCV are eligible.
  • - Malabsorption syndrome or any condition that can significantly impact the absorption of lenalidomide.
  • - Any of the following within 3 months prior to randomization (or first study intervention administration in safety run-in cohort): treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
  • - Received treatment (eg surgery, radiotherapy, medication) for a malignancy within 3 years of randomization (or first study intervention administration in safety run-in cohort) - Prior exposure to approved or investigational treatments for SMM or MM (including but not limited to conventional chemotherapies, immunomodulatory imid drugs, or Proteasome inhibitors); concurrent use of bisphosphonates or receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor denosumab is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted.
  • - Ongoing treatment with corticosteroids with a dose >10 mg prednisone or equivalent per day at the time of randomization (or first study intervention administration in safety run-in cohort) - Women of childbearing potential or male participant with women of childbearing potential who do not agree to use a highly effective method of birth control.
  • - Vaccination with a live vaccine 4 weeks before the start of the study drug.
Seasonal flu vaccines that do not contain live virus are permitted. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04270409
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sanofi
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Sciences & Operations
Principal Investigator Affiliation Sanofi
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lithuania, New Zealand, Norway, Poland, Spain, Sweden, Turkey, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plasma Cell Myeloma
Additional Details

Study duration is expected to be approximately 10 years, including a 28-day screening period, followed by an up to 36-month treatment period, and a follow-up period of approximately 7 years.

Arms & Interventions

Arms

Experimental: Isatuximab, lenalidomide, and dexamethasone (ILd)

Isatuximab intravenous (IV) administration on Days 1, 8, 15, and 22 during Cycle 1 (28 days per cycle), and Days 1 and 15 during Cycles 2-12, and Day 1 during subsequent cycles; lenalidomide per os (PO) administration on Days 1 to 21; and dexamethasone IV administration only on Day 1 during Cycle 1 and PO on Days 8, 15 and 22 of Cycle 1 and Days 1, 8, 15, and 22 of subsequent cycles

Active Comparator: Lenalidomide and dexamethasone (Ld)

Lenalidomide PO administration on Days 1 to 21 and dexamethasone PO administration on Days 1, 8, 15, and 22 of every 28-day cycle

Interventions

Drug: - Isatuximab SAR650984

Pharmaceutical for: Solution for infusion Route of administration: Intravenous

Drug: - Lenalidomide

Pharmaceutical form: Capsules Route of administration: Oral

Drug: - Dexamethasone

Pharmaceutical form: Tablets and solution for injection Route of administration: Oral and intravenous

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Investigational Site Number :8400007, Denver, Colorado

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Recruiting

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Investigational Site Number :8400007

Denver, Colorado, 80218

Investigational Site Number :8400011, Jacksonville, Florida

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Investigational Site Number :8400011

Jacksonville, Florida, 32256

Investigational Site Number :8400012, Miami, Florida

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Investigational Site Number :8400012

Miami, Florida, 33136

Investigational Site Number :8400001, Boston, Massachusetts

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Investigational Site Number :8400001

Boston, Massachusetts, 02115

Investigational Site Number :8400008, Boston, Massachusetts

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Investigational Site Number :8400008

Boston, Massachusetts, 02215

Investigational Site Number :8400015, Charlotte, North Carolina

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Investigational Site Number :8400015

Charlotte, North Carolina, 28204

Investigational Site Number :8400006, Nashville, Tennessee

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Investigational Site Number :8400006

Nashville, Tennessee, 37203

Investigational Site Number :8400002, Houston, Texas

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Investigational Site Number :8400002

Houston, Texas, 77030

International Sites

Investigational Site Number :0360008, Liverpool, New South Wales, Australia

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Recruiting

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Investigational Site Number :0360008

Liverpool, New South Wales, 2170

Investigational Site Number :0360005, Waratah, New South Wales, Australia

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Investigational Site Number :0360005

Waratah, New South Wales, 2298

Investigational Site Number :0360001, Wollongong, New South Wales, Australia

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Investigational Site Number :0360001

Wollongong, New South Wales, 2500

Investigational Site Number :0360002, Fitzroy, Victoria, Australia

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Investigational Site Number :0360002

Fitzroy, Victoria, 3065

Investigational Site Number :0360007, Heidelberg West, Victoria, Australia

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Investigational Site Number :0360007

Heidelberg West, Victoria, 3081

Investigational Site Number :0360004, Richmond, Victoria, Australia

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Investigational Site Number :0360004

Richmond, Victoria, 3121

Investigational Site Number :0360006, Nedlands, Western Australia, Australia

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Investigational Site Number :0360006

Nedlands, Western Australia, 6009

Investigational Site Number :0760002, Sao Paulo, São Paulo, Brazil

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Investigational Site Number :0760002

Sao Paulo, São Paulo, 04537-081

Investigational Site Number :1240004, Edmonton, Alberta, Canada

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Investigational Site Number :1240004

Edmonton, Alberta, T6G 1Z2

Investigational Site Number :1240005, Moncton, New Brunswick, Canada

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Recruiting

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Investigational Site Number :1240005

Moncton, New Brunswick, E1C 6Z8

Investigational Site Number :1240001, Montreal, Quebec, Canada

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Investigational Site Number :1240001

Montreal, Quebec, H1T 2M4

Investigational Site Number :1560002, Hangzhou, China

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Investigational Site Number :1560002

Hangzhou, , 310003

Investigational Site Number :1560003, Hangzhou, China

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Recruiting

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Investigational Site Number :1560003

Hangzhou, , 310003

Investigational Site Number :1560006, Nanchang, China

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Investigational Site Number :1560006

Nanchang, , 330006

Investigational Site Number :1560004, Shanghai, China

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Investigational Site Number :1560004

Shanghai, , 200032

Investigational Site Number :1560005, Shenyang, China

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Investigational Site Number :1560005

Shenyang, , 110022

Investigational Site Number :1560001, Tianjin, China

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Recruiting

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Investigational Site Number :1560001

Tianjin, , 300020

Investigational Site Number :2030004, Brno, Czechia

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Investigational Site Number :2030004

Brno, , 62500

Investigational Site Number :2030005, Hradec Kralove, Czechia

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Investigational Site Number :2030005

Hradec Kralove, , 50005

Investigational Site Number :2030002, Olomouc, Czechia

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Investigational Site Number :2030002

Olomouc, , 77900

Investigational Site Number :2030003, Ostrava - Poruba, Czechia

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Investigational Site Number :2030003

Ostrava - Poruba, , 70852

Investigational Site Number :2030001, Praha 2, Czechia

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Investigational Site Number :2030001

Praha 2, , 12808

Investigational Site Number :2080001, Aalborg, Denmark

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Investigational Site Number :2080001

Aalborg, , 9000

Investigational Site Number :2080003, Aarhus N, Denmark

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Investigational Site Number :2080003

Aarhus N, , 8200

Investigational Site Number :2080005, Hellerup, Denmark

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Investigational Site Number :2080005

Hellerup, , 2900

Investigational Site Number :2080002, Roskilde, Denmark

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Investigational Site Number :2080002

Roskilde, , 4000

Investigational Site Number :2500009, Ars-Laquenexy, France

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Investigational Site Number :2500009

Ars-Laquenexy, , 57085

Investigational Site Number :2500010, Bayonne Cedec, France

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Investigational Site Number :2500010

Bayonne Cedec, , 64109

Investigational Site Number :2500007, GRENOBLE Cedex 9, France

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Investigational Site Number :2500007

GRENOBLE Cedex 9, , 38043

Investigational Site Number :2500006, La Roche sur Yon, France

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Investigational Site Number :2500006

La Roche sur Yon, , 85925

Investigational Site Number :2500003, Lille, France

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Investigational Site Number :2500003

Lille, , 59037

Investigational Site Number :2500005, Paris, France

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Investigational Site Number :2500005

Paris, , 75012

Investigational Site Number :2500011, Paris, France

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Investigational Site Number :2500011

Paris, , 75013

Investigational Site Number :2500002, Poitiers Cedex, France

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Investigational Site Number :2500002

Poitiers Cedex, , 86021

Investigational Site Number :2500001, RENNES Cedex 09, France

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Investigational Site Number :2500001

RENNES Cedex 09, , 35033

Investigational Site Number :2760001, Hamburg, Germany

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Investigational Site Number :2760001

Hamburg, , 20246

Investigational Site Number :2760002, Heidelberg, Germany

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Investigational Site Number :2760002

Heidelberg, , 69120

Investigational Site Number :3000002, Athens, Greece

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Investigational Site Number :3000002

Athens, , 10676

Investigational Site Number :3000001, Athens, Greece

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Investigational Site Number :3000001

Athens, , 11528

Investigational Site Number :3000003, Thessaloniki, Greece

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Investigational Site Number :3000003

Thessaloniki, , PC 54007

Investigational Site Number :3480003, Budapest, Hungary

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Investigational Site Number :3480003

Budapest, , 1083

Investigational Site Number :3480001, Budapest, Hungary

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Recruiting

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Investigational Site Number :3480001

Budapest, , 1097

Investigational Site Number :3480002, Debrecen, Hungary

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Investigational Site Number :3480002

Debrecen, , 4032

Investigational Site Number :3480004, Kaposvár, Hungary

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Investigational Site Number :3480004

Kaposvár, , 7400

Investigational Site Number :3720003, Dublin 7, Dublin, Ireland

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Investigational Site Number :3720003

Dublin 7, Dublin,

Investigational Site Number :3720002, Dublin 8, Dublin, Ireland

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Investigational Site Number :3720002

Dublin 8, Dublin,

Investigational Site Number :3720001, Dublin 9, Dublin, Ireland

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Investigational Site Number :3720001

Dublin 9, Dublin,

Investigational Site Number :3760004, Ashdod, Israel

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Investigational Site Number :3760004

Ashdod, , 7747629

Investigational Site Number :3760001, Jerusalem, Israel

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Investigational Site Number :3760001

Jerusalem, , 91031

Investigational Site Number :3760002, Jerusalem, Israel

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Investigational Site Number :3760002

Jerusalem, , 91120

Investigational Site Number :3760005, Petah-Tikva, Israel

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Investigational Site Number :3760005

Petah-Tikva, , 49100

Investigational Site Number :3760003, Tel Aviv, Israel

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Investigational Site Number :3760003

Tel Aviv, , 64239

Investigational Site Number :3800006, Meldola, Forlì-Cesena, Italy

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Investigational Site Number :3800006

Meldola, Forlì-Cesena, 47014

Investigational Site Number :3800001, Rozzano, Milano, Italy

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Investigational Site Number :3800001

Rozzano, Milano, 20089

Investigational Site Number :3800005, Ancona, Italy

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Investigational Site Number :3800005

Ancona, , 60032

Investigational Site Number :3800003, Bologna, Italy

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Investigational Site Number :3800003

Bologna, , 40138

Investigational Site Number :3800002, Terni, Italy

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Investigational Site Number :3800002

Terni, , 05100

Investigational Site Number :3920002, Nagoya-shi, Aichi, Japan

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Investigational Site Number :3920002

Nagoya-shi, Aichi, 467-8602

Investigational Site Number :3920006, Kamogawa-shi, Chiba, Japan

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Investigational Site Number :3920006

Kamogawa-shi, Chiba, 296-8602

Investigational Site Number :3920008, Maebashi-shi, Gunma, Japan

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Recruiting

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Investigational Site Number :3920008

Maebashi-shi, Gunma, 371-8511

Investigational Site Number :3920010, Sapporo-shi, Hokkaido, Japan

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Recruiting

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Investigational Site Number :3920010

Sapporo-shi, Hokkaido, 060-8543

Investigational Site Number :3920005, Higashiibaraki-gun, Ibaraki, Japan

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Recruiting

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Investigational Site Number :3920005

Higashiibaraki-gun, Ibaraki, 311-3193

Investigational Site Number :3920004, Konan-ku, Yokohama-shi, Kanagawa, Japan

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Recruiting

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Investigational Site Number :3920004

Konan-ku, Yokohama-shi, Kanagawa, 234-0054

Investigational Site Number :3920003, Okayama-shi, Okayama, Japan

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Recruiting

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Investigational Site Number :3920003

Okayama-shi, Okayama, 701-1192

Investigational Site Number :3920007, Osaka-shi, Osaka, Japan

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Recruiting

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Investigational Site Number :3920007

Osaka-shi, Osaka, 543-8555

Investigational Site Number :3920009, Sunto-gun, Shizuoka, Japan

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Investigational Site Number :3920009

Sunto-gun, Shizuoka, 411-8777

Investigational Site Number :3920001, Shibuya-ku, Tokyo, Japan

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Recruiting

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Investigational Site Number :3920001

Shibuya-ku, Tokyo, 150-8935

Investigational Site Number :4100004, Gangnam-gu, Seoul-teukbyeolsi, Korea, Republic of

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Recruiting

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Investigational Site Number :4100004

Gangnam-gu, Seoul-teukbyeolsi, 06351

Investigational Site Number :4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of

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Recruiting

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Investigational Site Number :4100001

Seoul, Seoul-teukbyeolsi, 03722

Investigational Site Number :4100003, Seoul, Seoul-teukbyeolsi, Korea, Republic of

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Investigational Site Number :4100003

Seoul, Seoul-teukbyeolsi, 110-744

Investigational Site Number :4100002, Seoul, Korea, Republic of

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Investigational Site Number :4100002

Seoul, , 06591

Investigational Site Number :4400001, Vilnius, Lithuania

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Investigational Site Number :4400001

Vilnius, , 08661

Investigational Site Number :5540004, Christchurch, Canterbury, New Zealand

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Investigational Site Number :5540004

Christchurch, Canterbury,

Investigational Site Number :5540001, Hamilton, Waikato, New Zealand

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Recruiting

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Investigational Site Number :5540001

Hamilton, Waikato, 3204

Investigational Site Number :5540003, Auckland, New Zealand

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Investigational Site Number :5540003

Auckland, , 1023

Investigational Site Number :5780002, Bergen, Norway

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Investigational Site Number :5780002

Bergen, , 5021

Investigational Site Number :5780001, Oslo, Norway

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Investigational Site Number :5780001

Oslo, , 0450

Investigational Site Number :6160006, Bydgoszcz, Kujawsko-pomorskie, Poland

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Investigational Site Number :6160006

Bydgoszcz, Kujawsko-pomorskie, 85-168

Investigational Site Number :6160002, Lodz, Lódzkie, Poland

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Recruiting

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Investigational Site Number :6160002

Lodz, Lódzkie, 93-510

Investigational Site Number :6160008, Gdansk, Pomorskie, Poland

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Investigational Site Number :6160008

Gdansk, Pomorskie, 80-214

Investigational Site Number :6160005, Chorzow, Slaskie, Poland

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Investigational Site Number :6160005

Chorzow, Slaskie, 41-500

Investigational Site Number :7240004, Barcelona, Barcelona [Barcelona], Spain

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Investigational Site Number :7240004

Barcelona, Barcelona [Barcelona], 08036

Investigational Site Number :7240001, Barcelona, Barcelona [Barcelona], Spain

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Recruiting

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Investigational Site Number :7240001

Barcelona, Barcelona [Barcelona], 08041

Investigational Site Number :7240006, Pamplona, Navarra, Spain

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Recruiting

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Investigational Site Number :7240006

Pamplona, Navarra, 31008

Investigational Site Number :7240002, Valencia, Valenciana, Comunidad, Spain

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Investigational Site Number :7240002

Valencia, Valenciana, Comunidad, 46017

Investigational Site Number :7240005, Madrid, Spain

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Investigational Site Number :7240005

Madrid, , 28041

Investigational Site Number :7240007, Salamanca, Spain

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Investigational Site Number :7240007

Salamanca, , 37007

Investigational Site Number :7240003, Zaragoza, Spain

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Investigational Site Number :7240003

Zaragoza, , 50009

Investigational Site Number :7520003, Helsingborg, Sweden

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Investigational Site Number :7520003

Helsingborg, , 251 87

Investigational Site Number :7920005, Ankara, Turkey

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Investigational Site Number :7920005

Ankara, , 06010

Investigational Site Number :7920001, Ankara, Turkey

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Investigational Site Number :7920001

Ankara, ,

Investigational Site Number :7920004, Istanbul, Turkey

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Investigational Site Number :7920004

Istanbul, , 34214

Investigational Site Number :7920002, Istanbul, Turkey

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Investigational Site Number :7920002

Istanbul, , 34390

Investigational Site Number :7920003, Izmir, Turkey

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Investigational Site Number :7920003

Izmir, , 35040

Investigational Site Number :8260002, Bournemouth, Hampshire, United Kingdom

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Recruiting

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Investigational Site Number :8260002

Bournemouth, Hampshire, BH7 7DW

Investigational Site Number :8260003, London, London, City Of, United Kingdom

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Recruiting

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Investigational Site Number :8260003

London, London, City Of, SE1 7EH

Investigational Site Number :8260001, Leicester, United Kingdom

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Recruiting

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Investigational Site Number :8260001

Leicester, , LE15WW