A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide (MonumenTAL-6)

A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants With Relapsed or Refractory Myeloma Who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide

The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).

Study Overview

• Status: Recruiting
• Conditions: Relapsed or Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Pomalidomide; Drug: Teclistamab; Drug: Dexamethasone; Drug: Talquetamab; Drug: Elotuzumab; Drug: Bortezomib

• Study Type: Interventional
• Enrollment (Estimated): 795
• Phase: Phase 3

Contacts and Locations

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

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Recruiting
    • Royal Adelaide Hospital
  • Box Hill, Australia, 3128
    • Recruiting
    • Box Hill Hospital
  • Darlinghurst, Australia, 2010
    • Recruiting
    • St. Vincent's Hospital
  • Fitzroy, Australia, 3065
    • Recruiting
    • St. Vincent's Hospital Melbourne
  • Southport, Australia, 4215
    • Recruiting
    • Gold Coast University Hospital
  • Wollongong, Australia, 2500
    • Recruiting
    • Wollongong Hospital
• Belgium
  • Charleroi, Belgium, 6000
    • Recruiting
    • Grand Hopital de Charleroi, site Notre Dame
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg
  • Gent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
  • Sint-Niklaas, Belgium, 9100
    • Recruiting
    • AZ Nikolaas - Campus Sint-Niklaas Moerland
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V5C2
      • Recruiting
      • Juravinski Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • University Health Network (UHN) Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont
• China
  • Beijing, China, 100044
    • Recruiting
    • Peking University People s Hospital
• Czechia
  • Brno - Bohunice, Czechia, 625 00
    • Recruiting
    • Fakultni Nemocnice Brno
  • Hradec Kralove, Czechia, 500 05
    • Recruiting
    • Fakultni nemocnice Hradec Kralove
  • Ostrava, Czechia, 708 52
    • Recruiting
    • Fakultni Nemocnice Ostrava
• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
  • Odense C, Denmark, 5000
    • Recruiting
    • Odense University Hospital
  • Vejle, Denmark, 7100
    • Recruiting
    • Vejle Hospital
• France
  • Limoges, France, 87042
    • Recruiting
    • CHU de Limoges Hopital Dupuytren
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli Calmettes
  • Nantes, France, 44093
    • Recruiting
    • CHU Nantes
  • Pessac Cedex, France, 33604
    • Recruiting
    • CHU de Bordeaux - Hospital Haut-Leveque
  • Pierre-Benite, France, 69495
    • Recruiting
    • CHU Lyon Sud
  • TOURS Cedex 01, France, 37044
    • Recruiting
    • CHRU Tours Hopital Bretonneau
  • Toulouse Cedex 9, France, 31100
    • Recruiting
    • Institut Universitaire du Cancer Toulouse Oncopole
• Germany
  • Augsburg, Germany, 86156
    • Recruiting
    • Klinikum Augsburg
  • Halle (Saale), Germany, 06120
    • Recruiting
    • Universitaetsklinikum Halle (Saale)
  • München, Germany, 81675
    • Recruiting
    • Klinikum rechts der Isar der TU Muenchen
  • Tuebingen, Germany, 72076
    • Recruiting
    • Universitaetsklinikum Tuebingen
• India
  • Pune, India, 411004
    • Recruiting
    • Deenanath Mangeshkar Hospital and Research Centre
• Israel
  • Be'er Ya'akov, Israel, 70300
    • Recruiting
    • Shamir Medical Center (Assaf Harofeh)
  • Haifa, Israel, 3436212
    • Recruiting
    • Carmel Medical Center
  • Petah-Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical center - Petah-Tikva
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center
  • Tel Aviv-Yafo, Israel, 64239
    • Recruiting
    • Tel Aviv Sourasky Medical Center
• Italy
  • Alessandria, Italy, 15121
    • Recruiting
    • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
  • Brindisi, Italy, 72100
    • Recruiting
    • oncologia medica - Oncology
  • Legnano, Italy, 20025
    • Recruiting
    • Asst Ovest Milanese - Ospedale Di Legnano
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
  • Pescara, Italy, 65124
    • Recruiting
    • Presidio Ospedaliero Pescara
  • Ravenna, Italy, 48121
    • Recruiting
    • Ospedale S. Maria Delle Croci
• Japan
  • Bunkyo Ku, Japan, 113 8431
    • Recruiting
    • Juntendo University Hospital
  • Kanazawa, Japan, 920-8641
    • Recruiting
    • Kanazawa University Hospital
  • Kyoto, Japan, 602-8566
    • Recruiting
    • University Hospital Kyoto Prefectural University of Medicine
  • Niigata, Japan, 951-8566
    • Recruiting
    • Niigata Cancer Center Hospital
  • Shiwa-gun, Japan, 028-3695
    • Recruiting
    • Iwate Medical University Hospital
  • Suita-City, Japan, 565-0871
    • Recruiting
    • Osaka University Hospital
  • Tottori, Japan, 683-0824
    • Recruiting
    • Tottori University Hospital
  • Yokohama City, Japan, 241 8515
    • Recruiting
    • Kanagawa Cancer Center
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Recruiting
    • Dong-A University Hospital
  • Busan, Korea, Republic of, 49241
    • Recruiting
    • Pusan National University Hospital
  • Jeollanam-do, Korea, Republic of, 58128
    • Recruiting
    • Chonnam National University Hwasun Hospital
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • Recruiting
    • The Catholic University of Korea Seoul St. Mary's Hospital
  • Ulsan, Korea, Republic of, 44033
    • Recruiting
    • Ulsan University Hospital
• Netherlands
  • Almere, Netherlands, 1315RA
    • Recruiting
    • Flevoziekenhuis
  • Den Haag, Netherlands, 2545 CH
    • Recruiting
    • Haga ziekenhuis
  • Eindhoven, Netherlands, 5623 EJ
    • Recruiting
    • Catharinaziekenhuis
  • Nieuwegein, Netherlands, 3435 CM
    • Recruiting
    • St. Antonius Ziekenhuis Nieuwegein
  • Zwolle, Netherlands, 8025 AB
    • Recruiting
    • Isala Kliniek
• Poland
  • Brzozow, Poland, 36-200
    • Recruiting
    • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
  • Kielce, Poland, 25-734
    • Recruiting
    • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • Lublin, Poland, 20-090
    • Recruiting
    • Centrum Onkologii Ziemii Lubelskiej
  • Szczecin, Poland, 71-252
    • Recruiting
    • Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
  • Wroclaw, Poland, 52-007
    • Recruiting
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
• Spain
  • Asturias, Spain, 33394
    • Recruiting
    • Hosp. de Cabuenes
  • Burgos, Spain, 09003
    • Recruiting
    • Hosp. Univ. de Burgos
  • Cáceres, Spain, 10003
    • Recruiting
    • Hosp. San Pedro de Alcantara
  • Granada, Spain, 18014
    • Recruiting
    • Hosp. Univ. Virgen de Las Nieves
  • Lugo, Spain, 27003
    • Recruiting
    • Hosp. Univ. Lucus Augusti
  • Madrid, Spain, 28046
    • Recruiting
    • Hosp. Univ. La Paz
  • Palma de Mallorca, Spain, 07120
    • Recruiting
    • Hosp. Univ. Son Espases
  • Pamplona, Spain, 31008
    • Recruiting
    • Clinica Univ. de Navarra
  • Salamanca, Spain, 37007
    • Recruiting
    • Hosp. Clinico Univ. de Salamanca
  • San Sebastian, Spain, 20014
    • Recruiting
    • Hosp. Univ. Donostia
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Hosp. Clinico Univ. de Santiago
• Sweden
  • Lund, Sweden, 221 85
    • Recruiting
    • Skanes universitetssjukhus
  • Uppsala, Sweden, 75185
    • Recruiting
    • Akademiska Sjukhuset
  • Varberg, Sweden, 432 81
    • Recruiting
    • Varberg Hospital
• United Kingdom
  • Cardiff, United Kingdom, CF14 4HY
    • Recruiting
    • University Hospital of Wales
  • Plymouth, United Kingdom, PL6 8DH
    • Recruiting
    • University Hospitals Plymouth NHS Trust

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level >= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
• Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
• Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by IMWG criteria on or after their last regimen
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
• A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6months after the last dose of study treatment

Exclusion Criteria:

• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
• Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
• Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
• A maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
• Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Talquetamab + Pomalidomide (Tal-P); Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.	Drug: Pomalidomide; Pomalidomide will be administered orally.; Other Names: Pomalyst; Imnovid; Drug: Dexamethasone; Dexamethasone will be administered either orally or intravenously.; Drug: Talquetamab; Talquetamab will be administered as a SC injection.; Other Names: JNJ-64407564; Talvey
Experimental: Arm B: Talquetamab + Teclistamab (Tal-Tec); Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.	Drug: Teclistamab; Teclistamab will be administered as a SC injection.; Other Names: JNJ-64007957; Tecvayli; Drug: Dexamethasone; Dexamethasone will be administered either orally or intravenously.; Drug: Talquetamab; Talquetamab will be administered as a SC injection.; Other Names: JNJ-64407564; Talvey
Active Comparator: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd); Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication.	Drug: Pomalidomide; Pomalidomide will be administered orally.; Other Names: Pomalyst; Imnovid; Drug: Dexamethasone; Dexamethasone will be administered either orally or intravenously.; Drug: Elotuzumab; Elotuzumab will be administered intravenously.; Other Names: Empliciti; Drug: Bortezomib; Bortezomib will be administered as a SC injection.; Other Names: Velcade

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first.	Up to 6 years 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR is defined as the percentage of participants with best overall response of partial response (PR) or better according to international myeloma working group (IMWG) response criteria.	Up to 6 years 5 months
Complete Response (CR) or Better Rate	CR or better is defined as the percentage of participants with best overall response of CR or better according to IMWG response criteria.	Up to 6 years 5 months
Very Good Partial Response (VGPR) or Better Rate	VGPR or better is defined as the percentage of participants with best overall response of VGPR or better rate according to IMWG response criteria.	Up to 6 years 5 months
Minimal Residual Disease (MRD)-negative CR Rate	MRD-negative CR is defined as the percentage of participants who achieve both CR or better and MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy (SST).	Up to 6 years 5 months
Overall Survival (OS)	OS is defined as the time from randomization to the date of participant's death.	Up to 6 years 5 months
Progression Free Survival on Next-line Therapy (PFS2)	PFS2 is defined as time from randomization to progression on the next line of therapy or death, whichever comes first.	Up to 6 years 5 months
Time to Next Treatment (TTNT)	TTNT is defined as the time from randomization to the start of SST.	Up to 6 years 5 months
Serum Concentration of Talquetamab and Teclistamab	Serum concentration of talquetamab and teclistamab will be reported.	Up to 6 years 5 months
Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab	Number of participants with ADAs to talquetamab and teclistamab will be reported.	Up to 6 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)	Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.	Up to 6 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30	Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and 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.	Up to 6 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)	Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	Up to 6 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)	Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."	Up to 6 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey	Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. 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 as a composite of the Vanderbilt Head and Neck Symptom Survey.	Up to 6 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q	Change from baseline in symptoms, functioning, and HRQoL as assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.	Up to 6 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30	Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and 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 or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.	Up to 6 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L	Change from baseline in symptoms, functioning, and HRQoL as assessed by EQ-5D-5L will be reported. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	Up to 6 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S	Change from baseline in symptoms, functioning, and HRQoL as assessed by PGI-S will be reported. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."	Up to 6 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey	Change from baseline in symptoms, functioning, and HRQoL as assessed by epstein taste survey will be reported. 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 as a composite of the Vanderbilt Head and Neck Symptom Survey.	Up to 6 years 5 months
Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30	Percentage of participants with meaningful improvement in HRQol as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and 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 or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.	Up to 6 years 5 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): April 23, 2026
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Pomalidomide; Bortezomib; Elotuzumab
• Other Study ID Numbers: 64407564MMY3009 (Other Identifier: Janssen Research & Development, LLC); 2022-502446-27-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/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: Yes
• Studies a U.S. FDA-regulated device product: No