A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Subjects With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. This is a study to determine the adverse events, change in disease activity, and pharmacokinetics of Etentamig in adult participants with MM.

Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 2 phases; phase 2 with 3 study arms and phase 3 with 2 study arms. Participants in phase 2 will receive 1 of 3 doses of etentamig in combination with daratumumab. Participants in phase 3 will receive etentamig at RP3D in combination with daratumumab, or daratumumab, lenalidomide, and dexamethasone (DRd). Around 660 adult participants with MM will be enrolled at approximately 155 sites worldwide

Participants in phase 2 will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. Participants in phase 3 will receive RP3D doses of etentamig as IV infusions, combination with SC injections of daratumumab, or SC injections of daratumumab, capsules of lenalidomide, and tablet/ IV injections of dexamethasone (DRd). The study duration is approximately 16 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Etentamig; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Estimated): 660
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Hopital Saint-Louis /ID# 278429
  • Paris, France, 75012
    • Recruiting
    • Hopital Saint Antoine /ID# 278428
  • Auvergne-Rhône-Alpes
    • Epagny Metz Tessy, Auvergne-Rhône-Alpes, France, 74370
      • Recruiting
      • Centre Hospitalier Annecy Genevois /ID# 278406
  • Hauts-de-France
    • Dunkirk, Hauts-de-France, France, 59385
      • Recruiting
      • Centre Hospitalier De Dunkerque-Hospital Alexandra Lepeve /ID# 278399
    • Lille, Hauts-de-France, France, 59037
      • Recruiting
      • Chu De Lille - Hopital Claude Huriez /ID# 278413
  • Herault
    • Montpellier, Herault, France, 34295
      • Recruiting
      • CHU de Montpellier - Hopital Saint Eloi /ID# 278415
  • Indre-et-Loire
    • Tours, Indre-et-Loire, France, 37044
      • Recruiting
      • CHRU Tours - Hopital Bretonneau /ID# 279274
  • Morbihan
    • Vannes, Morbihan, France, 56000
      • Recruiting
      • CH Bretagne Atlantique /ID# 278422
  • New Aquitaine
    • Pessac, New Aquitaine, France, 33604
      • Recruiting
      • Centre Hospitalier Universitaire de Bordeaux /ID# 278419
    • Poitiers, New Aquitaine, France, 86021
      • Recruiting
      • Centre Hospitalier Universitaire de Poitiers /ID# 278398
  • Occitanie
    • Toulouse, Occitanie, France, 31059
      • Recruiting
      • IUCT Oncopole /ID# 278403
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44000
      • Recruiting
      • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 278402
    • St-Priest-en-Jarez, Pays de la Loire Region, France, 42270
      • Recruiting
      • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278421
  • Rhone
    • Pierre-Bénite, Rhone, France, 69495
      • Recruiting
      • HCL - Hopital Lyon Sud /ID# 282145
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75015
      • Recruiting
      • Hopital Universitaire Necker Enfants Malades /ID# 278426
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Recruiting
      • Nagoya City University Hospital /ID# 278188
  • Ehime
    • Matsuyama, Ehime, Japan, 790-8524
      • Recruiting
      • Matsuyama Red Cross Hospital /ID# 278660
  • Fukuoka
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Recruiting
      • Kurume University Hospital /ID# 278209
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Recruiting
      • Tokai University Hospital /ID# 278157
  • Kyoto
    • Kyoto, Kyoto, Japan, 602-8566
      • Recruiting
      • University Hospital Kyoto Prefectural University of Medicine /ID# 278156
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona /ID# 278532
  • León, Spain, 24071
    • Recruiting
    • Complejo Asistencial Universitario de Leon - Hospital de Leon /ID# 278534
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon y Cajal /ID# 278533
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre /ID# 278520
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Maranon /ID# 278551
  • Salamanca, Spain, 37007
    • Recruiting
    • Hospital Universitario de Salamanca /ID# 278530
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitari i Politecnic La Fe /ID# 278525
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Recruiting
      • Complejo Hospitalario Universitario de Santiago /ID# 278531
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Institut Catala d'Oncologia (ICO) - Badalona /ID# 278522
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla /ID# 278535
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
      • Recruiting
      • Hospital Universitario de Gran Canaria Doctor Negrín /ID# 278527
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Recruiting
      • Clinica Universidad de Navarra - Pamplona /ID# 278583
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic Hospital Scottsdale /ID# 278349
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center /ID# 278238
  • Colorado
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Colorado Blood Cancer Institute /ID# 279080
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Winship Cancer Institute of Emory University /ID# 277667
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Recruiting
      • Fort Wayne Medical Oncology And Hematology /ID# 278141
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Recruiting
      • Minnesota Oncology - Minneapolis Clinic /ID# 278720
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Hospital Rochester /ID# 277886
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai /ID# 277844
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine Myeloma Center /ID# 278216
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • University of North Carolina at Chapel Hill /ID# 277708
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Willamette Valley Cancer Institute and Research Center /ID# 278721
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI Oncology Partners /ID# 278353
  • Texas
    • The Woodlands, Texas, United States, 77380
      • Recruiting
      • Texas Oncology - The Woodlands /ID# 278726
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Texas Oncology - Northeast Texas /ID# 278725
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Virginia Cancer Specialists - Fairfax /ID# 278716
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Blue Ridge Cancer Care - Roanoke /ID# 278722

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and autologous stem cell transplants (ASCT).
• IMWG Myeloma Frailty Index Score of >= 1

• All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:

  • Serum M-protein >= 0.5 g/dL (>= 5 g/L).
  • Urine M-protein >= 200 mg/24 hours.
  • Serum free light chain (FLC) >= 100 mg/L (>= 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein.

Exclusion Criteria:

• Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
• Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study
• Participant who has known active central nervous system involvement of MM.
• Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2: Etentamig + Daratumumab Dose A; Participants will receive etentamig dose A in combination with daratumumab until the recommended phase 3 dose (RP3D), as part of the approximately 16 year study duration.	Drug: Daratumumab; Subcutaneous Injection; Drug: Etentamig; Intravenous (IV) Infusion
Experimental: Phase 2: Etentamig + Daratumumab Dose B; Participants will receive etentamig dose B in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.	Drug: Daratumumab; Subcutaneous Injection; Drug: Etentamig; Intravenous (IV) Infusion
Experimental: Phase 2: Etentamig + Daratumumab Dose C; Participants will receive etentamig dose C in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.	Drug: Daratumumab; Subcutaneous Injection; Drug: Etentamig; Intravenous (IV) Infusion
Experimental: Phase 3: Etentamig + Daratumumab RP3D; Participants will receive etentamig at the RP3D in combination with daratumumab, as part of the approximately 16 year study duration.	Drug: Daratumumab; Subcutaneous Injection; Drug: Etentamig; Intravenous (IV) Infusion
Experimental: Phase 3: Daratumumab, Lenalidomide, and Dexamethasone (DRd); Participants will receive DRd, as part of the approximately 16 year study duration.	Drug: Daratumumab; Subcutaneous Injection; Drug: Dexamethasone; Oral Tablet; Drug: Lenalidomide; Oral Capsule; Drug: Dexamethasone; IV Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 2 and 3: Percentage of Participants with Adverse Events (AE)s	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to Approximately 16 Years
Phase 2: Change in Clinical Activity	Clinical activity is defined as change in response rates [Overall Response Rate (ORR), Complete Response (CR) or Better, Very Good Partial Response (VGPR), Partial Response (PR)] as determined International Myeloma Working Group (IMWG (2016).	Up to Approximately 52 weeks
Phase 3: Minimal Residual Disease (MRD) Negative CR Rate	MRDnegCR rate, is defined as the percentage of participants who have achieved stringent complete response (sCR) or CR as assessed by independent review committee (IRC) and have negative MRD defined at 10^-5 threshold as assessed by next generation sequencing (NGS).	Up to Approximately 52 weeks
Phase 3: Progression-Free Survival (PFS)	PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by IRC per IMWG (2016) response criteria, or death, whichever occurs first.	Up to Approximately 130 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 2: MRD Negative CR Rate	MRDnegCR rate, is defined as the percentage of participants who have achieved sCR or CR and have negative MRD defined at 10^-5 threshold as assessed by NGS.	Up to Approximately 52 Weeks
Phase 2: PFS	PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by IRC per IMWG (2016) response criteria, or death, whichever occurs first.	Up to Approximately 130 Months
Phase 2: Sustained MRD Negativity Rate	The rate of sustained MRD-negativity is defined as the percentage of participants with maintenance of MRD negativity status in bone marrow confirmed >=12 months apart prior to initiation of new anti-MM therapy.	Up to Approximately 12 Months
Phase 2: Area Under the Serum Concentration-Time Curve (AUC)	Area under the plasma concentration-time curve (AUC).	Up to Approximately 12 Months
Phase 2: Overall Survival (OS)	OS is defined as the duration from the date of randomization to the date of the participant's death.	Up to Approximately 16 Years
Phase 2: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability	Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)	Up to Approximately 16 Years
Phase 2: Maximum Observed Serum Concentration (Cmax)	Maximum observed serum concentration (Cmax).	Up to Approximately 12 Months
Phase 2: Time to Cmax (Time to Maximum Observed Concentration, Tmax)	Time to Cmax.	Up to Approximately 12 Months
Phase 2: Positive Anti-Drug Antibodies (ADAs)	Positive ADAs.	Up to Approximately 90 days after the last dose of study treatment
Phase 2: Negative ADAs	Negative ADAs.	Up to Approximately 90 days after the last dose of study treatment
Phase 2: Neutralizing Anti-Drug Antibodies (NAbs)	Neutralizing anti-drug antibodies (NAbs).	Up to Approximately 90 days after the last dose of study treatment
Phase 3: OS	OS is defined as the duration from the date of randomization to the date of the participant's death.	Up to Approximately 16 Years
Phase 3: Sustained MRD Negativity Rate	The rate of sustained MRD-negativity is defined as the percentage of participants with maintenance of MRD negativity status in bone marrow confirmed >=12 months apart prior to initiation of new anti-MM therapy.	Up to Approximately 12 Months
Phase 3: Rate of >= CR	The rate of >= CR is defined as the percentage of participants who achieve a sCR or CR determined by IMWG (2016) response criteria, per IRC assessment, prior to the initiation of new anti-myeloma therapy.	Up to Approximately 12 Months
Phase 3: Rate of >= VGPR or Better	The rate of >= VGPR is defined as the percentage of participants who achieve a VGPR or better determined by IMWG (2016) response criteria, per IRC assessment, prior to the initiation of new anti-myeloma therapy.	Up to Approximately 12 Months
Phase 3: ORR	ORR is defined as percentage of participants with a response of PR or better per IMWG criteria.	Up to Approximately 52 Weeks
Phase 3: Time to Response (TTR)	TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria as assessed by investigator.	Up to Approximately 12 Months
Phase 3: Duration of Response (DOR)	DOR is defined as the number of days from the day the response criteria are met to the date that disease progression.	Up to Approximately 16 Years
Phase 3: Time-to-Progression (TTP)	Time to progression is defined as the number of days from the date of study drug start to the date of the first documented disease progression or relapse.	Up to Approximately 16 Years
Phase 3: Event Free Survival (EFS)	EFS will be measured as the number of days between the initiation of the studied line of therapy and disease progression, or refractory disease, or death.	Up to Approximately 16 Years
Phase 3: Progression-Free Survival on Subsequent Therapy (PFS2)	PFS2 is defined as the duration from the date of randomization to the date of confirmed disease progression or death on the next line of therapy.	Up to Approximately 16 Years
Phase 3: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability	Incidence, severity, seriousness, and causality of TEAEs	Up to Approximately 16 Years
Phase 3: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Score	The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Subjects rate items on a 4- point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).	Up to Approximately 16 Years
Phase 3: Change from Baseline in EORTC QLQ-C30 Global Health Status/QoL Score	The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Subjects rate items on a 4- point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).	Up to Approximately 16 Years
Phase 3: Change from Baseline and Time to Deterioration in the Remaining Scales and Items of EORTC QLQ-C30	The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Subjects rate items on a 4- point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).	Up to Approximately 16 Years
Phase 3: Symptomatic AEs as Assessed by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0/1 for absent/present).	Up to Approximately 16 Years
Phase 3: Overall Bother Due to Treatment Side Effects as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) GP5	The FACT-G GP5 Item is a part of the FACT-G which is a 27-item questionnaire that measures four domains of health-related quality of life (HRQOL) in cancer patients: physical, social, emotional and functional well-being. The FACT-G GP5 item ("I am bothered by side effects of treatment") is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on patients. This item is rated on a 5-point Likert scale from "not at all" to "very much.".	Up to Approximately 16 Years
Phase 3: Change from Baseline in Patient Global Impression of Severity (PGIS) Scores	The PGIS scale asks the patient to assess their overall QoL, as well as difficulty of doing physical activities due to MM over the past 7 days. Each item employs a 5-point Likert scale from "not at all" to "very much."	Up to Approximately 16 Years
Phase 3: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores	The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.	Up to Approximately 16 Years

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: IFM (Intergroupe Français du Myélome); PETHEMA (Program for the Study and Treatment of Haematological Malignances)
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2026
• Primary Completion (Estimated): January 1, 2042
• Study Completion (Estimated): January 1, 2042

Study Registration Dates

• First Submitted: July 24, 2025
• First Submitted That Met QC Criteria: July 24, 2025
• First Posted (Actual): July 31, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Daratumumab; Lenalidomide; Dexamethasone; Etentamig
• 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; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Polycyclic Compounds; Piperidines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; Dexamethasone; daratumumab
• Other Study ID Numbers: M25-586; 2025-520897-21 (Other Identifier: EUCT); 2025-520897-21-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No