MajesTEC-9: A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05572515
• Collaborator: (none)
• Enrollment: 590
• Locations: 189
• Arms: 2
• Anticipated Duration (Months): 99.6
• Patients Per Site: 3.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.

Condition or Disease	Intervention/Treatment	Phase
Relapsed or Refractory Multiple Myeloma	Drug: Teclistamab; Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Carfilzomib	Phase 3

Detailed Description

Multiple myeloma is an incurable, malignant, plasma cell disorder. Teclistamab (JNJ-64007957) is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine (PAA) bispecific antibody that targets the cluster of differentiation (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). With its dual binding sites, teclistamab is able to draw CD3 positive T cells in close proximity to BCMA positive cells, resulting in T-cell activation and subsequent lysis of BCMA positive cells. Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) that exerts potent, direct tumoricidal and immune-enhancing effects and Carfilzomib is a second-generation proteasome inhibitor that inhibits proteasome which results in disruption of protein turnover and induces apoptosis. The primary hypothesis of this study is that teclistamab monotherapy (Arm A) will significantly improve progression free survival (PFS) compared with investigator's choice of PVd or Kd (Arm B) in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. The study will include a screening phase, treatment phase, and follow-up phase. Safety will be assessed by physical examinations, neurologic examinations, eastern cooperative oncology group (ECOG) performance status, clinical laboratory tests, vital signs, and AE monitoring. The overall duration of the study will be up to 9 years.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 590 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide
• Anticipated Study Start Date: Jan 27, 2023
• Anticipated Primary Completion Date: Aug 14, 2025
• Anticipated Study Completion Date: May 16, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Teclistamab Participants will receive teclistamab monotherapy.	Drug: Teclistamab; Teclistamab will be administered subcutaneously.; Other Names: JNJ-64007957
Experimental: Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd) Participants will receive either PVd or Kd based on principal investigator's choice.	Drug: Pomalidomide; Pomalidomide will be administered orally.; Drug: Bortezomib; Bortezomib will be administered subcutaneously.; Drug: Dexamethasone; Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.; Drug: Carfilzomib; Carfilzomib will be administered intravenously.

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival (PFS) [Up to 9 years]

   PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first.

Secondary Outcome Measures

1. Overall Response (Partial Response [PR] or Better) [Up to 9 years]

   Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.

2. Very Good Partial Response (VGPR) or Better Response [Up to 9 years]

   VGPR or better (Stringent Complete Response [sCR]+Complete Response [CR]+VGPR) is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.

3. Complete Response (CR) or Better Response [Up to 9 years]

   CR or better response is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.

4. Minimal Residual Disease (MRD) Negativity [Up to 9 years]

   MRD negativity is defined as participants who achieve 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.

5. Duration of Response (DOR) [Up to 9 years]

   DOR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG 2016 response criteria or death due to any cause, whichever occurs first.

6. Time to Next Treatment (TTNT) [Up to 9 years]

   TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.

7. Progression-free Survival on Next-line Therapy (PFS2) [Up to 9 years]

   PFS2 is defined as the time interval between the date of randomization 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.

8. Overall Survival (OS) [Up to 9 years]

   OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.

9. Number of Participants with Adverse Events (AEs) by Severity [Up to 9 years]

   Number of participants with AEs by Severity will be reported.

10. Number of Participants with Serious Adverse Events (SAEs) by Severity [Up to 9 years]

    Number of participants with SAEs by Severity will be reported.

11. Number of Participants with Abnormal Laboratory Results [Up to 9 years]

    Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported.

12. Serum Concentrations of Teclistamab [Up to 9 years]

    Serum concentrations of teclistamab will be reported.

13. Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab [Up to 9 years]

    Number of participants with ADAs to teclistamab will be reported.

14. Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) [Baseline up to 9 years]

    Change from baseline in symptoms, functioning, and overall HRQoL assessed by EORTC QLQ-C30 score version 3 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/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). 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.

15. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score [Baseline up to 9 years]

    Change from baseline in symptoms, functioning, and overall HRQoL assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days", and responses are reported on a 5-point verbal rating scale.

16. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Baseline up to 6 months]

    Change from baseline in symptoms, functioning, and overall HRQoL assessed by PRO-CTCAE will be reported. The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common adverse events 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. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.

17. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) [Baseline up to 9 years]

    Change from baseline in symptoms, functioning, and overall HRQoL assessed by EQ-5D-5L will be reported. 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).

18. Time to Worsening in Symptoms, Functioning, and Overall HRQoL [Up to 9 years]

    Time to worsening in symptoms, functioning, and overall HRQoL will be measured as the interval from the date of randomization to the start date of meaningful change.

19. PFS in Participants in High-risk Molecular Features [Up to 9 years]

    PFS in participants in high-risk molecular features will be reported. PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the IMWG 2016 response criteria, or death due to any cause, whichever occurs first.

20. Depth of Response in Participants in High-risk Molecular Features [Up to 9 years]

    Depth of response in participants in high-risk molecular features will be reported.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio

• Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line

• Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria

• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2

• A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment

• Must be willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

• Received any prior B cell maturation antigen (BCMA)-directed therapy

• A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)

• Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.

• Received a live, attenuated vaccine within 4 weeks before randomization

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

• Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14 days prior to randomization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alta Bates Comprehensive Cancer Center	Berkeley	California	United States	94704
2	University of California, Irvine	Orange	California	United States	92868
3	PIH Health Hospital	Whittier	California	United States	90602
4	University of Connecticut	Farmington	Connecticut	United States	06030
5	University of Miami/Sylvester Cancer Center	Miami	Florida	United States	33136
6	Cleveland Clinic Florida	Weston	Florida	United States	33331
7	Saint Alphonsus Regional Medical Center- Cancer Care Center	Boise	Idaho	United States	83706
8	Tulane University Hospital & Clinics	New Orleans	Louisiana	United States	70112
9	Walter Reed National Military Medical Center	Bethesda	Maryland	United States	20814
10	Boston University Medical Center	Boston	Massachusetts	United States	02118
11	Saint Luke's Hospital - Saint Luke's Cancer Specialists	Chesterfield	Missouri	United States	63017
12	Cooper Health System MD Anderson Cancer Center at Cooper	Camden	New Jersey	United States	08103
13	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
14	Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center	New York	New York	United States	10032
15	Durham VAMC	Durham	North Carolina	United States	27705
16	University Hospital of Cleveland	Cleveland	Ohio	United States	44106
17	OhioHealth	Columbus	Ohio	United States	43214
18	Good Samaritan Hospital Corvallis	Corvallis	Oregon	United States	97330
19	Baptist Cancer Center	Memphis	Tennessee	United States	38120
20	Brooke Army Medical Center	San Antonio	Texas	United States	78219
21	Baylor Scott & White Clinic - Temple	Temple	Texas	United States	76508
22	Fort Belvoir Community Hospital	Fort Belvoir	Virginia	United States	22060
23	St. Vincent's Hospital Melbourne	Fitzroy		Australia	3065
24	Box Hill Hospital	Melbourne		Australia	3128
25	Fiona Stanley Hospital	Murdoch		Australia	6150
26	Sir Charles Gairdner Hospital	Nedlands		Australia	6009
27	LKH - Universitätsklinikum der PMU Salzburg	Salzburg		Austria	5020
28	Pyhrn-Eisenwurzen Klinikum Steyr	Steyr		Austria	4400
29	Medical University Vienna, MUV	Vienna		Austria	A-1090
30	Algemeen Ziekenhuis Klina	Brasschaat		Belgium	2930
31	Jolimont	Haine-St-Paul		Belgium	7100
32	Az Groeninge	Kortrijk		Belgium	8500
33	Universitair Ziekenhuis Gasthuisberg	Leuven		Belgium	3000
34	Hospitais Integradaos da Gavea S/A - DF Star	Brasilia		Brazil	70390-140
35	Instituto Joinvilense de Hematologia e Oncologia Ltda - Centro de Hematologia e Oncologia	Joinville		Brazil	89201-260
36	Liga Norte Riograndense Contra O Cancer	Natal		Brazil	59062-000
37	Complexo Hospitalar de Niterói	Niteroi		Brazil	24020-073
38	Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)	Rio de Janeiro		Brazil	22775-001
39	Hospital Sao Rafael	Salvador		Brazil	41253-190
40	Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base	Sao Jose do Rio Preto		Brazil	15090-000
41	Hemomed	Sao Paulo		Brazil	01236-030
42	Sociedade Beneficente de Senhoras - Hospital Sírio Libanês	Sao Paulo		Brazil	01308-901
43	Fundação Antônio Prudente - A.C. Camargo Cancer Center	Sao Paulo		Brazil	01509900
44	Instituto D'Or de Pesquisa e Ensino (IDOR)	Sao Paulo		Brazil	04501-000
45	Real e Benemérita Associação Portuguesa de Beneficência	São Paulo		Brazil	01321-001
46	Hospital Alemão Oswaldo Cruz	São Paulo		Brazil	01323-001
47	Clinica Sao Germano	São Paulo		Brazil	01455-010
48	Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein	São Paulo		Brazil	05652-900
49	Tom Baker Cancer Centre	Calgary	Alberta	Canada	T2N 4N2
50	Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L2
51	Nova Scotia Health Authority	Halifax	Nova Scotia	Canada	B3H 1V7
52	Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
53	Lakeridge Health Oshawa	Oshawa	Ontario	Canada	L1G2B9
54	CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont	Montreal	Quebec	Canada	H1T 2M4
55	Peking Union Medical College Hospital	Beijing		China	100006
56	Beijing Chaoyang Hospital	Beijing		China	100020
57	The First Bethune Hospital of Jilin University	Changchun		China	130021
58	The Third Xiangya Hospital, Central South University	Changsha		China	410013
59	Sichuan Provincial People's Hospital	Chengdu		China	610032
60	Chongqing University Cancer Hospital	Chongqing		China	400030
61	Fujian Meidical University Union Hospital	Fu Zhou		China	350001
62	Sun Yat -Sen University Cancer Center	Guangzhou		China	510060
63	First affiliated Hospital of Zhejiang University	Hangzhou		China	310003
64	Harbin medical university cancer hospital	Harbin		China	150081
65	The First Affiliated Hospital of NanChang University	Nanchang		China	330006
66	Nanjing Drum Tower Hospital	Nanjing		China	210008
67	First Affiliated Hospital of Guangxi Medical University	Nanning		China	530021
68	Ruijin Hospital, Shanghai Jiao Tong University	Shanghai		China	200025
69	Shengjing Hospital of China Medical University	Shenyang		China	110055
70	Shenzhen 2nd People's Hospital	Shenzhen		China	518025
71	Institute of Hematology & Blood Diseases Hospital	Tian Jin		China	300020
72	Tianjin Medical University Cancer Institute and Hospital	Tianjin		China	300060
73	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou		China	325000
74	Wuhan Union Hospital	Wuhan		China	430023
75	Wuxi People's Hospital	Wuxi		China	214023
76	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an		China	710004
77	Henan Cancer Hospital	Zhengzhou		China	450008
78	Fakultni nemocnice Brno	Brno		Czechia	625 00
79	Fakultni nemocnice Ostrava	Ostrava		Czechia	70852
80	Vseobecna fakultni nemocnice v Praze	Praha 2		Czechia	128 08
81	Aalborg University Hospital	Aalborg		Denmark	9000
82	Rigshospitalet	Copenhagen		Denmark	DK-2100
83	Regionshospitalet Gødstrup	Herning		Denmark	7400
84	Vejle Sygehus	Vejle		Denmark	7100
85	Hôpital Côte de Nacre	Caen cedex 9		France	14003
86	CHU Grenoble	Grenoble		France	38700
87	Centre Hospitalier du Mans	Le Mans		France	72000
88	Institut Paoli Calmettes	Marseille		France	13009
89	CHU de Montpellier, Hopital Saint-Eloi	Montpellier		France	34090
90	CHU Nantes	Nantes Cedex 1		France	44000
91	Hopital de la Pitie Salpetriere	Paris		France	75013
92	Hôpital Necker Enfants Malades	Paris		France	75743
93	Institut Universitaire du Cancer Toulouse Oncopole	Toulouse		France	31100
94	CHU de Nancy - Hôpital de Brabois	Vandœuvre-lès-Nancy		France	54500
95	Carl-Thiem-Klinikum Cottbus gGmbH	Cottbus		Germany	03048
96	Universitätsklinikum Carl Gustav Carus Dresden	Dresden		Germany	01307
97	Universitätsmedizin Greifswald	Greifswald		Germany	17475
98	Asklepios Klinik Altona	Hamburg		Germany	22763
99	Universitätsklinikum Heidelberg	Heidelberg		Germany	69120
100	Universitatsmedizin Leipzig	Leipzig		Germany	04103
101	Universitaetsklinikum Giessen und Marburg GmbH	Marburg		Germany	35043
102	Universitätsklinikum Ulm	Ulm		Germany	89070
103	Heinrich-Braun-Klinikum gGmbH	Zwickau		Germany	08060
104	Alexandra General Hospital of Athens	Athens Attica		Greece	115 28
105	Agios Andreas General Hospital of Patra	Patra		Greece	263 35
106	'G. Papanikolaou' Hospital of Thessaloniki	Thessaloniki		Greece	570 10
107	M S Ramaiah Medical College and Hospital	Bangalore		India	560054
108	Post Graduate Institute of Medical Education & Research (PGIMER)	Chandigarh		India	160012
109	Fortis Memorial Research Institute	Gurgaon		India	122002
110	Medanta The Medicity	Gurugram		India	122001
111	Bhagwan Mahaveer Cancer Hospital & Research Centre	Jaipur		India	302017
112	Tata Medical Center	Kolkata		India	700156
113	Tata Memorial Hospital	Mumbai		India	400012
114	Kingsway Hospital	Nagpur		India	440001
115	Jawaharlal Institute of Postgraduate Medical Education and Research	Pondicherry		India	605008
116	Deenanath Mangeshkar Hospital and Research Centre	Pune		India	411004
117	Bnai Zion Medical Center	Haifa		Israel	31048
118	Carmel Medical Center	Haifa		Israel	3436212
119	Rabin Medical Center	Petah Tikva		Israel	49100
120	Sheba Medical Center	Ramat Gan		Israel	52621
121	Tel-Aviv Sourasky Medical Center	Tel Aviv-Yafo		Israel	64239
122	A.O.U Sant'Orsola-Malpighi	Bologna		Italy	40138
123	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano		Italy	20133
124	Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone	Palermo		Italy	90127
125	Ospedale Santa Chiara AO Universitaria Pisana	Pisa		Italy	56126
126	Campus Bio-Medico di Roma	Roma		Italy	00128
127	A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette	Turin		Italy	10126
128	ASUI Santa Maria della Misericordia di Udine	Udine		Italy	33100
129	Ospedale di Circolo e Fondazione Macchi	Varese		Italy	21100
130	Chiba Cancer Center	Chiba		Japan	260-0801
131	Ogaki Municipal Hospital	Gifu		Japan	503-8502
132	Hitachi General Hospital	Hitachi		Japan	317-0077
133	Saitama Medical University Hospital	Iruma-gun		Japan	350-0495
134	Kameda General Hospital	Kamogawa City		Japan	296-0041
135	Kurashiki Central Hospital	Kurashiki		Japan	710-8602
136	Matsuyama Red Cross Hospital	Matsuyama		Japan	790-8524
137	Aichi Medical University Hospital	Nagakute		Japan	480-1195
138	Niigata University Medical & Dental Hospital	Niigata		Japan	951-8520
139	National Hospital Organization Okayama Medical Center	Okayama		Japan	701-1192
140	Osaka Metropolitan University Hospital	Osaka		Japan	545-8586
141	Hokkaido University Hospital	Sapporo		Japan	060-8648
142	Juntendo University Hospital	Tokyo		Japan	113-0033
143	The Cancer Institute Hospital of JFCR	Tokyo		Japan	135-8550
144	Yamanashi Prefectural Central Hospital	Yamanashi		Japan	400-8506
145	Hospital Pulau Pinang	Georgetown		Malaysia	10450
146	Hospital Queen Elizabeth	Kota Kinabalu		Malaysia	88200
147	University Malaya Medical Centre	Kuala Lumpur		Malaysia	59100
148	Subang Jaya Medical Centre	Subang Jaya		Malaysia	47500
149	Meander Medisch Centrum	Amersfoort		Netherlands	3813 TZ
150	VUMC Amsterdam	Amsterdam		Netherlands	1081 HV
151	Universitair Medisch Centrum Groningen	Groningen		Netherlands	9700 RB
152	UMC Utrecht	Utrecht		Netherlands	3584 CX
153	Uniwersyteckie Centrum Kliniczne	Gdansk		Poland	80-214
154	Pratia Onkologia Katowice	Katowice		Poland	40-519
155	Szpital Uniwersytecki w Krakowie	Krakow		Poland	31-501
156	Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie	Lublin		Poland	20-081
157	Hosp. Garcia de Orta	Almada		Portugal	2805-267
158	Champalimaud Foundation Champalimaud Centre	Lisbon		Portugal	1400-038
159	Instituto Portugues de Oncologia	Porto		Portugal	4200072
160	Hospital de Vila Nova de Gaia E.P.E.	Vila Nova de Gaia		Portugal	4434-502
161	Institut Catala d'Oncologia L'Hospitalet	Hospitalet de Llobregat		Spain	08908
162	Hosp. De Jerez De La Frontera	Jerez de la Frontera		Spain	11407
163	Hosp. Univ. Infanta Leonor	Madrid		Spain	28031
164	Hosp. Univ. Ramon Y Cajal	Madrid		Spain	28034
165	Hosp. Gral. Univ. J.M. Morales Meseguer	Murcia		Spain	30008
166	Hospital Universitario Central de Asturias	Oviedo		Spain	33011
167	Hosp. Son Llatzer	Palma de Mallorca		Spain	07198
168	Hosp. Montecelo	Pontevedra		Spain	36071
169	Hospital Universitari i Politecnic La Fe	València		Spain	46026
170	Falu Lasarett Medicinkliniken Falun	Falun		Sweden	791 82
171	Helsingborgs lasarett	Helsingborg		Sweden	25287
172	Linkoping University Hospital	Linköping		Sweden	58185
173	Akademiska Sjukhuset	Uppsala		Sweden	751 85
174	Ankara Gulhane Training and Research Hospital	Ankara		Turkey	06010
175	Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital	Ankara		Turkey	06200
176	Ankara University Medical Faculty	Ankara		Turkey	06620
177	Antalya Training And Research Hospital	Antalya		Turkey	07100
178	Ondokuz Mayis University	Atakum		Turkey	55280
179	Medipol University Hospital	Istanbul		Turkey	34214
180	Istanbul University Istanbul Medical Faculty	Istanbul		Turkey	34452
181	Dokuz Eylul University Medical Faculty	Izmir		Turkey	35330
182	Aberdeen Royal Infirmary	Aberdeen		United Kingdom	AB25 2ZN
183	University Hospitals Birmingham NHS Foundation Trust	Birmingham		United Kingdom	B15 2GW
184	Colchester Hospital University NHS	Colchester		United Kingdom	CO4 5JL
185	St George's Hospital	London		United Kingdom	SW17 0QT
186	James Cook University Hospital	Middlesborough		United Kingdom	Ts4 3Bw
187	Norfolk and Norwich University Hospital	Norwich		United Kingdom	NR4 7UY
188	Royal Stoke University Hospital	Staffordshire		United Kingdom	ST4 6QG
189	The Clatterbridge Cancer Centre	Wirral		United Kingdom	CH63 4JY

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: NCT05572515
• Other Study ID Numbers: CR109244; 64007957MMY3006; 2022-000928-37
• First Posted: Oct 7, 2022
• Last Update Posted: Jan 30, 2023
• Last Verified: Jan 1, 2023

• 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; Bortezomib; Pomalidomide

Study Results

No Results Posted as of Jan 30, 2023