A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma (MoMMent)

A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.

Study Overview

• Status: Recruiting
• Conditions: Relapsed/Refractory Multiple Myeloma
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Austria
  • Leoben, Austria, 8700
    • Recruiting
    • LKH Leoben
  • Vienna, Austria, 1060
    • Recruiting
    • Krankenhaus der barmherzigen Schwestern
• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • UZ Antwerpen
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg
  • Leuven, Belgium, 3000
    • Completed
    • UZ Leuven
  • Mons, Belgium, 7000
    • Recruiting
    • Chu Helora Hospital De Mons Site Kennedy
  • Sint-Niklaas, Belgium, 9100
    • Recruiting
    • Vitaz
  • Yvoir, Belgium, 5530
    • Completed
    • Ucl de Mont-Godinne
• France
  • Lille, France, 59037
    • Completed
    • CHRU de Lille Hopital Claude Huriez
  • Montpellier, France, 34295
    • Completed
    • CHU de Montpellier Hopital Saint Eloi
  • Nantes, France, 44093
    • Completed
    • CHU de Nantes hotel Dieu
  • Pierre-Bénite, France, 69495
    • Completed
    • Centre Hospitalier Lyon-Sud
  • Toulouse, France, 31059
    • Completed
    • Pôle IUC Oncopole CHU
• Germany
  • Berin, Germany, 12203
    • Completed
    • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Cologne, Germany, 50397
    • Completed
    • Universitaetsklinikum Koeln
  • Dresden, Germany, 01307
    • Completed
    • Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden
  • Hamburg, Germany, 20251
    • Completed
    • Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik
  • Hamm, Germany, 59073
    • Completed
    • St. Barbara-Klinik Hamm GmbH
  • Heidelberg, Germany, 69120
    • Completed
    • Universitaetsklinikum Heidelberg
  • Karlsruhe, Germany
    • Completed
    • Staedtisches Klinikum Karlsruhe gGmbH
  • Leipzig, Germany, 04103
    • Completed
    • MVZ Mitte-Onkologische Schwerpunktpraxis
  • Leipzig, Germany, 4103
    • Completed
    • Universitaetsklinikum Leipzig
  • Tübingen, Germany, 72076
    • Completed
    • Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
  • Würzburg, Germany, 97080
    • Completed
    • Universitätsklinikum Würzburg
  • Zwickau, Germany, 08060
    • Completed
    • Heinrich-Braun-Klinikum gGmbH
• Greece
  • Alexandroupoli, Greece, 68100
    • Recruiting
    • University Hospital of Alexandroupolis
  • Athens, Greece, 115 26
    • Recruiting
    • Henry Dunant Hospital Center
  • Athens, Greece, 115 28
    • Recruiting
    • Alexandra Hospital
  • Athens, Greece, 115 27
    • Recruiting
    • Laiko General Hospital Of Athens 1
  • Athens, Greece, 115 27
    • Recruiting
    • Laiko General Hospital of Athens 2
  • Piraeus, Greece, 18537
    • Recruiting
    • Metaxa Cancer Center Hospital Of Piraeus
  • Rio, Greece, 265 04
    • Recruiting
    • General University Hospital of Patras
  • Thessaloniki, Greece, 54636
    • Recruiting
    • AHEPA University General Hospital of Thessaloniki
  • Thessaloniki, Greece, 546 39
    • Recruiting
    • Anticancer Hospital of Thessaloniki Theageneio
• Italy
  • Bari, Italy, 70124
    • Recruiting
    • U.O. Ematologia Istituto Tumori Giovanni Paolo II
  • Bari, Italy, 70124
    • Completed
    • Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
  • Bologna, Italy, 40138
    • Recruiting
    • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
  • Catania, Italy, 95128
    • Completed
    • Policlinico di Catania
  • Civitanova Marche, Italy, 62012
    • Recruiting
    • Ospedale Civile di Civitanova Marche
  • Genova, Italy, 16132
    • Recruiting
    • Ospedale Policlinico San Martino IRCCS
  • Genova, Italy, 16132
    • Completed
    • IRCCS Azienda Ospedaliera San Martino - IST
  • Lecce, Italy, 73100
    • Recruiting
    • Ospedale Vito Fazzi
  • Meldola, Italy, 47014
    • Completed
    • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
  • Padova, Italy, 35128
    • Completed
    • Universita degli Studi di Padova Azienda Ospedaliera di Pa
  • Palermo, Italy, 90146
    • Recruiting
    • Ospedale Villa Sofia-Cervello
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
  • Pescara, Italy, 65124
    • Recruiting
    • Presidio Ospedaliero Pescara
  • Reggio Calabria, Italy, 89124
    • Recruiting
    • Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A Gemelli IRCCS
  • Roma, Italy, 00161
    • Completed
    • Università di Roma La Sapienza
  • Roma, Italy, 128
    • Recruiting
    • Campus Bio Medico di Roma
  • San Giovanni Rotondo, Italy, 71013
    • Recruiting
    • Casa Sollievo Della Sofferenza IRCCS
  • San Giovanni Rotondo, Italy, 71013
    • Completed
    • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Tricase, Italy, 73039
    • Completed
    • Ospedale Cardinale G. Panico
  • Vicenza, Italy, 36100
    • Recruiting
    • Azienda Ulss 8 Berica- Ospedale Di Vicenza
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Completed
    • VU Medisch Centrum
  • Groningen, Netherlands, 9713 GZ
    • Completed
    • UMCG
• Portugal
  • Chaves, Portugal, 5400 482
    • Recruiting
    • Ulstmad - Hosp. Chaves
  • Coimbra, Portugal, 3004 561
    • Recruiting
    • Uls Coimbra - Hosp. Univ. Coimbra
  • Porto, Portugal, 4200 319
    • Recruiting
    • Uls Sao Joao - Hosp. Sao Joao
• Romania
  • Bucharest, Romania, 022328
    • Recruiting
    • Fundeni Clinical Institute
  • Cluj-Napoca, Romania, 400015
    • Recruiting
    • Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca 1
• Spain
  • Barcelona, Spain, 08908
    • Completed
    • Inst. Cat. Doncologia-H Duran I Reynals
  • Gijón, Spain, 33394
    • Recruiting
    • Hosp. de Cabuenes
  • Granada, Spain, 18014
    • Recruiting
    • Hosp. Univ. Virgen de Las Nieves
  • Jerez de la Frontera, Spain, 11407
    • Completed
    • Hosp. de Jerez de La Frontera
  • León, Spain, 24008
    • Recruiting
    • Hosp. de Leon
  • Madrid, Spain, 28034
    • Completed
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28041
    • Completed
    • Hosp. Univ. 12 de Octubre
  • Palma, Spain, 7120
    • Recruiting
    • Hosp. Univ. Son Espases
  • Pamplona, Spain, 31008
    • Completed
    • Clinica Univ. de Navarra
  • Salamanca, Spain, 37007
    • Recruiting
    • Hosp Clinico Univ de Salamanca
  • Santander, Spain, 39008
    • Recruiting
    • Hosp. Univ. Marques de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Completed
    • Hosp. Clinico Univ. de Santiago
  • Valencia, Spain, 46010
    • Recruiting
    • Hosp. Clinico Univ. de Valencia
  • Valencia, Spain, 46017
    • Recruiting
    • Hosp. Univ. Dr. Peset
  • Valladolid, Spain, 47003
    • Completed
    • Hosp. Clinico Univ. de Valladolid
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hosp. Univ. Miguel Servet
• Switzerland
  • Chur, Switzerland, 7000
    • Recruiting
    • Kantonsspital Graubünden
  • Winterthur, Switzerland, 8400
    • Recruiting
    • Kantonsspital Winterthur, Medizinische Onkologie
  • Zurich, Switzerland, 8091
    • Recruiting
    • Universitatsspital Zurich
  • Zurich, Switzerland, 8032
    • Recruiting
    • Hirslanden Klinik Hirslanden
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Completed
    • Southmead Hospital
  • London, United Kingdom, NW1 2PG
    • Completed
    • University College Hospital
  • London, United Kingdom, SE5 9RS
    • Completed
    • Kings College Hospital
  • London, United Kingdom, SW17 OQT
    • Completed
    • St Georges Hospital
  • Maidstone, United Kingdom, ME16 9QQ
    • Completed
    • Maidstone Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Completed
    • Nottingham University Hospitals NHS Trust
  • Surrey, United Kingdom, SM2 5PT
    • Completed
    • The Royal Marsden NHS Trust Sutton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of participants with previously treated multiple myeloma, having received standard of care (SOC) antimyeloma treatments during local clinical practices.

Description

Inclusion Criteria:

• For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and/or refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date
• For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1. For Period 3: Have ECOG performance status of 0,1 or 2
• For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period
• For Period 1,2 and 3: Participants must sign an ICF indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection
• For Period 1 and 2: Received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy
• For Period 1 and 2: Must have documented evidence of progressive disease based on participating physician's determination of response by the IMWG response criteria on or after the last regimen. Participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible
• For Period 1 and 2: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level 1.0 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
• Period 1: Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens)
• Period 2: Received as part of previous therapy a PI, an IMiD, an anti-CD38 antibody, and BCMA-targeted therapy (prior exposure can be from different monotherapy or combination regimens)
• For period 3: At least one of the following prior to the start of talquetamab: a. Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) or urine M-protein level >= 200 milligram (mg) /24 hours; or b. serum immunoglobulin free light chain >= 10 milligrams per deciliter (mg/dL) and abnormal ratio of involved and uninvolved free light chains or c. presence of bone lesions or plasmacytomas (>=1 lesion has 2 diameters >= 1 centimeter [cm])

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with Relapsed/Refractory Multiple Myeloma; Participants with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The primary data source will be medical records of each participant.	Other: No intervention; There is no interventional treatment component for participants with RRMM in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC).	Up to 52 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Very Good Partial Response (VGPR) Rate	VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria.	Up to 52 months
Complete Response (CR) Rate	CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria.	Up to 52 months
Stringent Complete Response (sCR) Rate	sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria.	Up to 52 months
Minimal Residual Disease (MRD) Negative Rate	MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria.	Up to 52 months
Clinical Benefit Rate (CBR)	CBR is defined as the percentage of participants with clinical benefit. CBR=ORR (sCR + CR + VGPR + PR) + minimal response (MR).	Up to 52 months
Duration of Response (DOR)	DOR is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease as defined in the IMWG criteria.	Up to 52 months
Time to Response (TTR)	TTR is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the participant has met all criteria for PR or better response.	Up to 52 months
Time to Best Response	Time to best response is defined as the time between the date of Day 1 of Cycle 1 and best objective response.	Up to 52 months
Time to Next Treatment (TTNT)	TTNT is defined as the time from diagnosis to the start of the next-line treatment.	Up to 52 months
Progression-free Survival (PFS)	PFS is defined as the time from the date of Day 1 of Cycle 1 to the date of first documented disease progression (as defined in the IMWG response criteria) or death due to any cause, whichever occurs first.	Up to 52 months
Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2)	PFS2 is defined as the time from the date of Day 1 of Cycle 1 to progression on the next line of subsequent antimyeloma therapy or death, whichever occurs first.	Up to 52 months
Overall Survival (OS)	OS is the duration from the date of Day 1 of Cycle 1 to the date of the participant's death or study completion, whichever occurs first.	Up to 52 months
Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score	The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.	Baseline up to 52 months
Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)	The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	Baseline up to 52 months
Period 1 and 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39	EORTC QLQ-IL39 (four single items from the EORTC QLQMY20) will be performed to assess emotional health status (feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future) on scale of 1 (not at all) to 4 (very much).	Baseline up to 52 months
Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 52 months
Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)	Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death related to adverse event.	Up to 52 months
Period 3: Number of Participants Reporting Oral Toxicities Using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	PRO-CTCAE consist of 1-8 questions of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. The following items were selected for inclusion for patients with multiple myeloma: nausea, vomiting, diarrhea, shortness of breath, rash, dizziness, headache, taste changes, and fatigue/tiredness/lack of energy.	Up to 52 months
Period 3: Number of Participants Reporting Oral Toxicity Symptoms Using the Epstein Taste Survey (ETS)	The Epstein Taste Survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. Developed for use in patients with head and neck cancer.	Up to 52 months
Period 3: Percentage of Participants with Overall Response to Subsequent Therapies	Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC). Overall response for subsequent therapies, including BCMA-targeted therapies after treatment with talquetamab will be reported.	Up to 52 months

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutica N.V., Belgium
• Investigators: Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial, Janssen Pharmaceutica N.V., Belgium

Publications and helpful links

General Publications

• Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez-Lopez J, Rodriguez-Otero P, Dytfeld D, Diels J, Strulev V, Haddad I, Renaud T, Ammann E, Cabrieto J, Perualila N, Gan R, Zhang Y, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Apr;41(4):1576-1593. doi: 10.1007/s12325-024-02797-x. Epub 2024 Feb 24.
• Moreau P, Mateos MV, Gonzalez Garcia ME, Einsele H, De Stefano V, Karlin L, Lindsey-Hill J, Besemer B, Vincent L, Kirkpatrick S, Delforge M, Perrot A, van de Donk NWCJ, Pawlyn C, Manier S, Leleu X, Martinez-Lopez J, Ghilotti F, Diels J, Morano R, Albrecht C, Strulev V, Haddad I, Pei L, Kobos R, Smit J, Slavcev M, Marshall A, Weisel K. Comparative Effectiveness of Teclistamab Versus Real-World Physician's Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Feb;41(2):696-715. doi: 10.1007/s12325-023-02738-0. Epub 2023 Dec 19.
• Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez Lopez J, Rodriguez-Otero P, Dytfeld D, Jakubowiak A, Schinke C, Besemer B, Anguille S, Manier S, Rasche L, Teipel R, Scheid C, Pawlyn C, Cavo M, Diels J, Ghilotti F, Lau BW, Renaud T, Orel O, Ong F, Ramos DF, Ammann E, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent. Adv Ther. 2026 Jan;43(1):333-355. doi: 10.1007/s12325-025-03409-y. Epub 2025 Nov 28.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: CR109118; 64407564MMY4001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No