Multiple Myeloma Clinical Trial
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Summary
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.
Full 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.
Eligibility Criteria
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
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There are 103 Locations for this study
Orange California, 92868, United States
Whittier California, 90602, United States
Weston Florida, 33331, United States
Fitzroy , 3065, Australia
Melbourne , 3128, Australia
Murdoch , 6150, Australia
Brasschaat , 2930, Belgium
Haine-St-Paul , 7100, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Natal , 59062, Brazil
Niteroi , 24020, Brazil
Rio de Janeiro , 22775, Brazil
Sao Paulo , 01308, Brazil
Sao Paulo , 01509, Brazil
Sao Paulo , 04501, Brazil
São Paulo , 01321, Brazil
São Paulo , 01323, Brazil
Changsha , 41001, China
Chengdu , 61003, China
Guangzhou , 51006, China
Hangzhou , 31000, China
Nanchang , 33000, China
Tian Jin , 30002, China
Wenzhou , 32500, China
Wuhan , 43002, China
Wuxi , 21402, China
Brno , 625 0, Czechia
Ostrava - Poruba , 708 5, Czechia
Praha 2 , 128 0, Czechia
Aalborg , 9000, Denmark
Copenhagen , DK-21, Denmark
Herning , 7400, Denmark
Vejle , 7100, Denmark
Caen cedex 9 , 14003, France
Grenoble , 38700, France
Le Mans , 72000, France
Montpellier , 34090, France
Nantes Cedex 1 , 44000, France
Paris , 75013, France
Paris , 75743, France
Toulouse , 31100, France
Vandœuvre-lès-Nancy , 54500, France
Cottbus , 03048, Germany
Dresden , 01307, Germany
Greifswald , 17475, Germany
Hamburg , 22763, Germany
Athens Attica , 115 2, Greece
Patra , 263 3, Greece
Thessaloniki , 570 1, Greece
Bangalore , 56005, India
Chandigarh , 16001, India
Gurugram , 12200, India
Jaipur , 30201, India
Kolkata , 70015, India
Mumbai , 40001, India
Nagpur , 44000, India
Pondicherry , 60500, India
Haifa , 31048, Israel
Haifa , 34362, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Tel Aviv-Yafo , 64239, Israel
Bologna , 40138, Italy
Milano , 20133, Italy
Palermo , 90127, Italy
Roma , 00128, Italy
Udine , 33100, Italy
Varese , 21100, Italy
Gifu , 503-8, Japan
Hirakata , 573-1, Japan
Hitachi , 317-0, Japan
Iruma-gun , 350-0, Japan
Kamogawa City , 296-8, Japan
Kurashiki , 710-8, Japan
Matsuyama , 790-8, Japan
Nagasaki-Shi , 852-8, Japan
Niigata , 951-8, Japan
Okayama , 701-1, Japan
Osaka , 545-8, Japan
Sapporo , 060-8, Japan
Tokyo , 113-0, Japan
Tokyo , 135-8, Japan
Yamanashi , 400-8, Japan
Georgetown , 10450, Malaysia
Kota Kinabalu , 88200, Malaysia
Kuala Lumpur , 59100, Malaysia
Subang Jaya , 47500, Malaysia
Amersfoort , 3813 , Netherlands
Groningen , 9700 , Netherlands
Gdansk , 80-21, Poland
Katowice , 40-51, Poland
Lublin , 20-08, Poland
Hospitalet de Llobregat , 08908, Spain
Jerez de la Frontera , 11407, Spain
Madrid , 28031, Spain
Madrid , 28034, Spain
Murcia , 30008, Spain
Oviedo , 33011, Spain
Palma de Mallorca , 07198, Spain
Pontevedra , 36071, Spain
València , 46026, Spain
Falun , 791 8, Sweden
Helsingborg , 25287, Sweden
Uppsala , 751 8, Sweden
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