MonumenTAL-3: A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05455320
• Collaborator: (none)
• Enrollment: 810
• Locations: 192
• Arms: 3
• Anticipated Duration (Months): 78.1
• Patients Per Site: 4.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab in combination with pomalidomide and dexamethasone (DPd).

Condition or Disease	Intervention/Treatment	Phase
Relapsed or Refractory Multiple Myeloma	Drug: Talquetamab; Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone	Phase 3

Detailed Description

Multiple myeloma is a malignant plasma cell disorder that accounts for approximately 10 percent (%) of all hematologic cancers, making it the second most common hematologic malignancy. Overall rationale of study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first). Efficacy, safety (physical examinations, neurologic examinations, Eastern Cooperative Oncology Group [ECOG] performance status, clinical laboratory tests, vital signs, and AE monitoring), pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Total duration of study will be up to 6 years 6 months.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 810 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy
• Anticipated Study Start Date: Oct 3, 2022
• Anticipated Primary Completion Date: Feb 6, 2026
• Anticipated Study Completion Date: Apr 6, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP) Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: JNJ-64407564 ; Drug: Daratumumab; Daratumumab will be administered subcutaneously.; Drug: Pomalidomide; Pomalidomide will be administered orally.; Drug: Dexamethasone; Dexamethasone will be administered orally or intravenously.
Experimental: Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd) Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication.	Drug: Pomalidomide; Pomalidomide will be administered orally.; Drug: Dexamethasone; Dexamethasone will be administered orally or intravenously.
Experimental: Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D) Participants will receive talquetamab and daratumumab as injection SC injection.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: JNJ-64407564 ; Drug: Daratumumab; Daratumumab will be administered subcutaneously.; Drug: Dexamethasone; Dexamethasone will be administered orally or intravenously.

Outcome Measures

Primary Outcome Measures

1. Progression-Free Survival (PFS) [Up to 6 years 6 months]

   PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first.

Secondary Outcome Measures

1. Overall Response (Partial Response [PR] or Better) [Up to 6 years 6 months]

   Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria.

2. Very Good Partial Response (VGPR) or Better Rate [Up to 6 years 6 months]

   VGPR or better rate is defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria.

3. Complete Response (CR) or Better Rate [Up to 6 years 6 months]

   CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria.

4. Overall Minimal Residual Disease (MRD) Negative Status [Up to 6 years 6 months]

   Overall MRD negative status is defined as percentage of participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy.

5. Overall Survival (OS) [Up to 6 years 6 months]

   OS is defined as the time from the date of first dose of study drug to the date of the participant's death.

6. Progression-free Survival on Next-line Therapy (PFS2) [Up to 6 years 6 months]

   PFS2 is defined as the time interval between the date of first dose of study drug and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.

7. Time to Next Therapy (TTNT) [Up to 6 years 6 months]

   TTNT is defined as the time from first dose of study drug to the start of subsequent antimyeloma treatment.

8. Number of Participants with Adverse Events (AEs) [Up to 6 years 6 months]

   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.

9. Number of Participants with AEs by Severity [Up to 6 years 6 months]

   Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

10. Serum Concentrations of Talquetamab [Up to 6 years 6 months]

    Serum concentrations of talquetamab will be reported.

11. Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab [Up to 6 years 6 months]

    Number of participants with presence ADAs to talquetamab will be reported.

12. Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab [Up to 6 years 6 months]

    Number of participants with presence of ADAs to daratumumab will be reported.

13. Time to Worsening in Symptoms, Functioning, and Overall Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) [Up to 6 years 6 months]

    The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30).

14. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c [Up to 6 years 6 months]

    The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed--length short form derived from the PROMIS Physical Function item bank.

15. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 [Up to 6 years 6 months]

    Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.

16. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE [Up to 6 years 6 months]

    The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.

17. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) [Up to 6 years 6 months]

    The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.

18. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S) [Up to 6 years 6 months]

    The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.

19. Change From Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) [Baseline up to 6 years 6 months]

    The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30.

20. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c [Baseline up to 6 years 6 months]

    The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed-length short form derived from the PROMIS Physical Function item bank.

21. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 [Baseline up to 6 years 6 months]

    Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.

22. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE [Baseline up to 6 years 6 months]

    The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.

23. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) [Baseline up to 6 years 6 months]

    The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.

24. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S) [Baseline up to 6 years 6 months]

    The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg)/24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio

• Relapsed or refractory disease as defined: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment; b) Refractory disease is defined as less than (<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (=<) 60 days after cessation of treatment

• Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed

• Documented evidence of progressive disease based on investigator's determination of response by the 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

Exclusion Criteria:

• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients

• Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)

• A maximum cumulative dose of corticosteroids to >=140 milligrams (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

• Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Arizona Cancer Center	Tucson	Arizona	United States	85719
2	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	City of Hope	Duarte	California	United States	91010
4	University of California San Francisco	San Francisco	California	United States	94143
5	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
6	University of Miami Health System	Miami	Florida	United States	33136
7	Grady Memorial Hospital	Atlanta	Georgia	United States	30303
8	University of Kansas	Westwood	Kansas	United States	66205
9	Oschner Health System	New Orleans	Louisiana	United States	70121-2429
10	University Of Maryland Medical Center	Baltimore	Maryland	United States	21201
11	Massachusetts General	Boston	Massachusetts	United States	02114
12	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655
13	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
14	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
15	Washington University School of Medicine	Saint Louis	Missouri	United States	63110-1032
16	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
17	NYU Langone Health	New York	New York	United States	10016
18	University of North Carolina	Chapel Hill	North Carolina	United States	27599
19	Levine Cancer Institute, Carolinas HealthCare System	Charlotte	North Carolina	United States	28204
20	Novant Health	Charlotte	North Carolina	United States	28204
21	The Ohio State University Wexner Medical Center - James Cancer Hospital	Columbus	Ohio	United States	43210
22	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107-4215
23	Baptist Cancer Center	Memphis	Tennessee	United States	38120
24	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
25	Houston Methodist Hospital	Houston	Texas	United States	77030
26	Virginia Commonwealth University - Massey Cancer Center	Richmond	Virginia	United States	23219
27	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
28	UZ Brussel	Brussel		Belgium	1090
29	UZA	Edegem		Belgium	2650
30	Virga Jessa Ziekenhuis	Hasselt		Belgium	3500
31	CHC MontLegia	Liège		Belgium	4000
32	Clinique Saint Pierre	Ottignies		Belgium	1340
33	UCL Mont Godinne	Yvoir		Belgium	5530
34	DF Star	Brasilia		Brazil	70390-140
35	Fundação Universidade de Caxias do Sul	Caxias do Sul		Brazil	95070 560
36	Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer	Curitiba		Brazil	81520-060
37	Centro de Pesquisas Oncológicas - CEPON	Florianópolis		Brazil	88034-000
38	Liga Norte Riograndense Contra O Cancer	Natal		Brazil	59062-000
39	Santa Casa Porto Alegre	Porto Alegre		Brazil	90050-170
40	Oncoclínicas	Rio de Janeiro		Brazil	22250 905
41	Instituto COI de Pesquisa, Educacao e Gestao	Rio de Janeiro		Brazil	22793-080
42	Hospital Sao Rafael	Salvador		Brazil	41253-190
43	Instituto de Ensino E Pesquisa Sao Lucas	Sao Paulo		Brazil	01236-030
44	Fundação Antônio Prudente - A.C. Camargo Cancer Center	Sao Paulo		Brazil	01509-010
45	Hospital Sirio Libanes	São Paulo		Brazil	01308901
46	Hospital Paulistano	São Paulo		Brazil	01321-001
47	Clinica Sao Germano	São Paulo		Brazil	01455-010
48	Hospital Das Clinicas de Ribeirão Preto - Usp	São Paulo		Brazil	14051-140
49	Instituto D'Or de Pesquisa e Ensino (IDOR)	São Paulo		Brazil	4501000
50	Beijing Chaoyang Hospital	Beijing		China	100020
51	Peking University First Hospital	Beijing		China	100034
52	Peking Union Medical College Hospital	Beijing		China	100730
53	The First Hospital of Jilin University	Changchun		China	130021
54	The second Xiangya Hospital of Central South University	Changsha		China	410011
55	Sichuan Academy of Medical Science Sichuan Provincial People's Hospital	Chengdu		China	610072
56	Xinqiao Hospital. Army Medical University	Chongqing		China	400037
57	Fujian Medical University Union Hospital	Fuzhou		China	350001
58	Sun Yat-Sen University Cancer Center	Guangzhou		China	510060
59	Guangdong Provincial People's Hospital	Guangzhou		China	510080
60	The First Affiliated Hospital, Zhejiang University College of Medicine	Hangzhou		China	310003
61	Nanjing Drum Tower Hospital	Nanjing		China	210008
62	Tongji Hospital of Tongji University	Shanghai		China	200065
63	Peking University Shenzhen Hospital	Shenzhen		China	518036
64	First Affiliated Hospital, SooChow University	Su Zhou		China	215006
65	Tianjin cancer hospital	Tianjin		China	300060
66	Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science	Tianjin		China	300320
67	Tongji Hospital, Tongji Medical College of HUST	Wuhan		China	430030
68	The First Affiliated Hospital of Xi'an Jiaotong University	Xi' An		China	710061
69	Henan Cancer Hospital	Zhengzhou		China	450008
70	Fakultni nemocnice Brno	Brno		Czechia	625 00
71	Fakultni nemocnice Hradec Kralove	Hradec Kralove		Czechia	500 05
72	Fakultní nemocnice Olomouc	Olomouc		Czechia	779 00
73	Fakultni nemocnice Ostrava	Ostrava		Czechia	70852
74	Fakultni nemocnice Kralovske Vinohrady	Praha 10		Czechia	100 34
75	Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie	Praha 2		Czechia	128 08
76	APHP - Hopital Henri Mondor	Creteil		France	94010
77	CHU Dijon	Dijon		France	21000
78	Centre Leon Bérard	Lyon		France	69008
79	CHU de Montpellier - Hopital Saint-Eloi	Montpellier Cedex 5		France	34295
80	C.H.U. Hotel Dieu - France	Nantes		France	44093
81	CHU HOPITAL DE L'ARCHET - Hematology	Nice N/a		France	06202
82	CHU Hôpital Saint Antoine	Paris Cedex 12		France	75571
83	CHRU - Hôpital du Haut Lévêque - Centre François Magendie	Pessac		France	33604
84	Chu Rennes - Hopital Pontchaillou	Rennes		France	35000
85	Institut Universitaire du cancer de Toulouse-Oncopole	TOULOUSE Cedex 9		France	31059
86	Charite Campus Benjamin Franklin	Berlin		Germany	12203
87	Universitatsklinikum Essen	Essen		Germany	D-45147
88	Asklepios Klinik Altona	Hamburg		Germany	22763
89	Universitaetsklinikum Heidelberg	Heidelberg		Germany	69120
90	Universitaetsklinikum Koeln	Koeln		Germany	50937
91	Universitatsklinikum Leipzig	Leipzig		Germany	04103
92	Universitätsmedizin der Johannes Gutenberg Universität	Mainz		Germany	55131
93	Klinikum rechts der Isar der TU Munchen	Munchen		Germany	81675
94	Universitätsklinikum Würzburg	Würzburg		Germany	97080
95	Alexandra General Hospital of Athens	Athens Attica		Greece	115 28
96	University of Athens - Evaggelismos Hospital (Evangelismos Hospital)	Athens		Greece	106 76
97	'G. Papanikolaou' Hospital of Thessaloniki	Thessalonikis		Greece	570 10
98	Anticancer Hospital of Thessaloniki 'Theageneio'	Thessaloniki		Greece	546 39
99	Bnai Zion Medical Center	Haifa		Israel	31048
100	Rambam Medical Center	Haifa		Israel	31096
101	Carmel Medical Center	Haifa		Israel	34362
102	Shaare Zedek Medical Center	Jerusalem		Israel	9103102
103	Hadassah Medical Center	Jerusalem		Israel	91120
104	Galilee Medical Center	Nahariya		Israel	22100
105	Beilinson medical center	Petah Tikva		Israel	49100
106	Sheba Medical Center	Ramat Gan		Israel	52621
107	Ziv Medical Center	Safed		Israel	13100
108	Sourasky (Ichilov) Medical Center	Tel Aviv		Israel	6423906
109	A.O. Universitaria Ospedali Riuniti di Ancona	Ancona		Italy	60126
110	Policlinico di Bari	Bari		Italy	70124
111	Azienda Ospedaliera Policlinico S. Orsola-Malpighi	Bologna		Italy	40138
112	Azienda Ospedaliera Spedali Civili di Brescia	Brescia		Italy	25123
113	PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania	Catania		Italy	95123
114	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano		Italy	20133
115	ASST Grande Ospedale Metropolitano Niguarda	Milano		Italy	20162
116	Azienda Ospedaliera Universitaria di Padova	Padova		Italy	35128
117	Ospedale Villa Sofia-Cervello	Palermo		Italy	90146
118	Arcispedale Santa Maria Nuova - IRCCS	Reggio Emilia		Italy	42123
119	Presidio Ospedaliero Santo Spirito in Sassia	Roma		Italy	00193
120	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo		Italy	71013
121	A.O.U. Città della Salute e della Scienza	Torino		Italy	10126
122	Chiba Cancer Center	Chiba		Japan	260-8717
123	Ogaki Municipal Hospital	Gifu		Japan	503-8502
124	Gunma University Hospital	Gunma		Japan	371-0034
125	Kansai Medical University Hospital	Hirakata		Japan	573-1191
126	Kobe City Medical Center General Hospital	Hyogo		Japan	650-0047
127	Hyogo Medical University Hospital	Hyôgo		Japan	663-8501
128	Shonan Kamakura General Hospital	Kamakura-shi		Japan	247-8533
129	National Cancer Center Hospital East	Kashiwa		Japan	277-8577
130	Kumamoto University Hospital	Kumamoto		Japan	860-8556
131	Kyoto Kuramaguchi Medical Center	Kyoto		Japan	603-8151
132	National Hospital Organization Matsumoto Medical Center	Matsumoto		Japan	399-8701
133	Niigata Cancer Center Hospital	Niigata		Japan	951-8566
134	Hokkaido University Hospital	Sapporo-shi		Japan	060-8648
135	Tohoku University Hospital	Sendai		Japan	980-8574
136	Iwate Medical University Hospital	Shiwa-gun		Japan	028-3695
137	Osaka University Hospital	Suita-shi		Japan	565-0871
138	The Cancer Institute Hospital of JFCR	Tokyo		Japan	135-8550
139	National Cancer Center	Gyeonggi-do		Korea, Republic of	10408
140	Gachon University Gil Medical Center	Incheon		Korea, Republic of	21565
141	Chonnam National University Hwasun Hospital	Jeollanam-do		Korea, Republic of	58128
142	Seoul National University Hospital	Seoul		Korea, Republic of	03080
143	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
144	Asan Medical Center	Seoul		Korea, Republic of	05505
145	Samsung Medical Center	Seoul		Korea, Republic of	06351
146	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
147	Haga zkh	Den-Haag		Netherlands	2545 CH
148	Albert Schweitzer ziekenhuis-lokatie Dordwijk	Dordrecht		Netherlands	3318 AT
149	Maxima Medisch Centrum	Eindhoven		Netherlands	5631 BM
150	Maastricht University Medical Centre	Maastricht		Netherlands	6229 HX
151	Erasmus MC	Rotterdam		Netherlands	3015 CN
152	Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza	Brzozow		Poland	36-200
153	Uniwersyteckie Centrum Kliniczne	Gdansk		Poland	80-214
154	Pratia Onkologia Katowice	Katowice		Poland	40-519
155	Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach	Kielce		Poland	25-734
156	Szpital Uniwersytecki w Krakowie	Krakow		Poland	31-501
157	Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli	Lublin		Poland	20090
158	SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział Hematologii	Olsztyn		Poland	10-228
159	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Warszawa		Poland	02-781
160	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw		Poland	50-367
161	Hosp. Univ. Germans Trias I Pujol	Badalona		Spain	08916
162	Hosp. Univ. Vall D Hebron	Barcelona		Spain	08035
163	Hosp. Clinic I Provincial de Barcelona	Barcelona		Spain	08036
164	Hosp. de La Santa Creu I Sant Pau	Barcelona		Spain	08041
165	Hosp. Univ. Virgen de La Arrixaca	El Palmar, Murcia		Spain	30120
166	Hosp. de Jerez de La Frontera	Jerez de la Frontera		Spain	11407
167	Hosp. de Leon	Leon		Spain	24071
168	Hosp. Univ. de La Princesa	Madrid		Spain	28006
169	Hosp. Univ. 12 de Octubre	Madrid		Spain	28041
170	Hosp. Virgen de La Victoria	Malaga		Spain	29010
171	Hosp. Clinico Univ. de Salamanca	Salamanca		Spain	37007
172	Hosp. Univ. de Canarias	San Cristóbal de La Laguna		Spain	38320
173	Hosp. Univ. Dr. Peset	Valencia		Spain	46017
174	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan	80756
175	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	83301
176	China Medical University Hospital	Taichung City		Taiwan	40447
177	National Cheng Kung University Hospital	Tainan		Taiwan	704
178	National Taiwan University Hospital	Taipei		Taiwan	10048
179	Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit	Ankara		Turkey	06200
180	Ankara University Medical Faculty	Ankara		Turkey	06590
181	Istanbul University Istanbul Medical Faculty	Istanbul		Turkey	34093
182	Medipol University Hospital	Istanbul		Turkey	34214
183	Dokuz Eylul University Medical Faculty	Izmir		Turkey	35340
184	On Dokuz Mayıs University Medical Faculty	Samsun		Turkey	55139
185	Blackpool Victoria Hospital	Blackpool		United Kingdom	FY3 8NR
186	Ninewells Hospital	Dundee		United Kingdom	DD1 9SY
187	Newcastle Freeman Hospital	Newcastle Upon Tyne		United Kingdom	NE7 7DN
188	Nottingham City Hospital	Nottingham		United Kingdom	NG5 1PB
189	Derriford Hospital	Plymouth		United Kingdom	PL6 8DH
190	Royal Hallamshire Hospital	Sheffield		United Kingdom	S10 2JF
191	Royal Marsden Hospital	Sutton		United Kingdom	SM2 5PT
192	New Cross Hospital	Wolverhampton		United Kingdom	WV10 0QP

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT05455320
• Other Study ID Numbers: CR109082; 2021-000202-22; 64407564MMY3002
• First Posted: Jul 13, 2022
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Dexamethasone; Daratumumab; Pomalidomide

Study Results

No Results Posted as of Aug 12, 2022