A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Oct 5, 2022
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called teclistamab for patients with relapsed or refractory multiple myeloma, which means their cancer has returned or has not responded to previous treatments. The researchers want to compare the effectiveness of teclistamab alone with two other treatment combinations that include medications called pomalidomide, bortezomib, and dexamethasone or carfilzomib and dexamethasone. There are two parts to the study: the first part compares these treatments directly, while the second part looks at a different way to give teclistamab.
To participate in this trial, individuals must be between 65 and 74 years old and have a documented diagnosis of multiple myeloma. They should have received 1 to 3 previous treatments and have measurable signs of their disease. Participants will need to agree to certain lifestyle restrictions and must not be pregnant or breastfeeding. Throughout the trial, participants will receive regular monitoring and support from the research team to assess their health and the treatment's effects. This trial is currently recruiting patients, and it could be a valuable opportunity for those looking for new treatment options for their multiple myeloma.
Gender
ALL
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)
- • Received a maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14 days prior to randomization
- • Received a live, attenuated vaccine within 4 weeks before randomization
- • Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma
- • 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
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Orange, California, United States
Varese, , Italy
Saint John, New Brunswick, Canada
Calgary, Alberta, Canada
Fort Sam Houston, Texas, United States
Berkeley, California, United States
Miami, Florida, United States
Ramat Gan, , Israel
Vejle, , Denmark
New Brunswick, New Jersey, United States
Cleveland, Ohio, United States
Orlando, Florida, United States
London, , United Kingdom
Boston, Massachusetts, United States
Tacoma, Washington, United States
Haifa, , Israel
Weston, Florida, United States
Norfolk, Virginia, United States
Columbus, Ohio, United States
Salt Lake City, Utah, United States
Aarhus, , Denmark
Mumbai, , India
Kortrijk, , Belgium
Aberdeen, , United Kingdom
Oshawa, Ontario, Canada
Ulm, , Germany
Norwich, , United Kingdom
Aurora, Colorado, United States
Leuven, , Belgium
Farmington, Connecticut, United States
Nedlands, , Australia
Hamilton, Ontario, Canada
Uppsala, , Sweden
Liege, , Belgium
Houston, Texas, United States
Sapporo, , Japan
Utrecht, , Netherlands
Copenhagen, , Denmark
Yamanashi, , Japan
Dresden, , Germany
Kuala Lumpur, , Malaysia
Heidelberg, , Germany
Bethesda, Maryland, United States
Nashville, Tennessee, United States
Marseille, , France
London, , United Kingdom
Tübingen, , Germany
Heidelberg, , Germany
Groningen, , Netherlands
Paris, , France
Praha 2, , Czechia
Ulm, , Germany
Odense C, , Denmark
Dresden, , Germany
Orange, California, United States
Petah Tikva, , Israel
Aalborg, , Denmark
Chiba, , Japan
Hamburg, , Germany
Anchorage, Alaska, United States
Pisa, , Italy
Hirakata, , Japan
Murcia, , Spain
Krakow, , Poland
Gdansk, , Poland
Durham, North Carolina, United States
Lublin, , Poland
Okayama, , Japan
Aarhus, , Denmark
Niigata, , Japan
Harbin, , China
Brno, , Czechia
Oviedo, , Spain
Milano, , Italy
Lille, , France
Ostrava, , Czechia
Kashiwa, , Japan
Tokyo, , Japan
Fitzroy, , Australia
Bethesda, Maryland, United States
Fort Belvoir, Virginia, United States
Cottbus, , Germany
Tianjin, , China
Nanjing, , China
Gilbert, Arizona, United States
Corvallis, Oregon, United States
Memphis, Tennessee, United States
Zhengzhou, , China
Grenoble, , France
Ostrava Poruba, , Czechia
Amsterdam, , Netherlands
Amersfoort, , Netherlands
Greifswald, , Germany
Brasschaat, , Belgium
Kurashiki, , Japan
Nanchang, , China
Zwickau, , Germany
Murdoch, , Australia
Salzburg, , Austria
Tel Aviv, , Israel
Wuhan, , China
Porto, , Portugal
Madrid, , Spain
Colchester, , United Kingdom
Haifa, , Israel
Natal, , Brazil
Olomouc, , Czechia
Hangzhou, , China
Denizli, , Turkey
Miami, Florida, United States
Beijing, , China
Wuxi, , China
Le Mans, , France
Paris, , France
Houston, Texas, United States
Halifax, Nova Scotia, Canada
Chandigarh, , India
Madrid, , Spain
Madrid, , Spain
Box Hill, , Australia
Wirral, , United Kingdom
Palermo, , Italy
Fitzroy, , Australia
Katowice, , Poland
Badalona, , Spain
Changchun, , China
Chongqing, , China
New Orleans, Louisiana, United States
Osaka, , Japan
San Antonio, Texas, United States
Matsuyama, , Japan
Subang Jaya, , Malaysia
Nagakute, , Japan
Bangalore, , India
Gurgaon, , India
Toulouse, , France
Shanghai, , China
Hadera, , Israel
Harbin, , China
Pune, , India
Iruma Gun, , Japan
Silver Spring, Maryland, United States
London, , United Kingdom
Udine, , Italy
Whittier, California, United States
Jaipur, , India
Kolkata, , India
Pondicherry, , India
Salvador, , Brazil
São Paulo, , Brazil
Wenzhou, , China
Changsha, , China
Gunma, , Japan
Brampton, Ontario, Canada
Joinville, , Brazil
Olomouc, , Czechia
Athens Attica, , Greece
Gifu, , Japan
Pozuelo De Alarcon, , Spain
São Paulo, , Brazil
Palma De Mallorca, , Spain
Vienna, , Austria
Lisbon, , Portugal
Birmingham, , United Kingdom
València, , Spain
Reggio Emilia, , Italy
Montreal, Quebec, Canada
Niterói, , Brazil
Sao Paulo, , Brazil
Antalya, , Turkey
Roma, , Italy
Siena, , Italy
New York, New York, United States
Gdansk, , Poland
Kielce, , Poland
Ankara, , Turkey
Tübingen, , Germany
Jerez De La Frontera, , Spain
Nagpur, , India
Pontevedra, , Spain
Almada, , Portugal
Braga, , Portugal
Ankara, , Turkey
Izmir, , Turkey
Turin, , Italy
Xi'an, , China
Istanbul, , Turkey
São Paulo, , Brazil
Bologna, , Italy
Hitachi, , Japan
Blacktown, , Australia
Paris, , France
São Paulo, , Brazil
São Paulo, , Brazil
Haine St Paul, , Belgium
São Paulo, , Brazil
Liverpool, , United Kingdom
Guangzhou, , China
Melbourne, , Australia
Anchorage, Alaska, United States
Marburg, , Germany
Nagasaki Shi, , Japan
Gurugram, , India
Nanning, , China
Atakum, , Turkey
Amiens Cedex 1, , France
Amersfoort, , Netherlands
Oviedo, , Spain
Nantes Cedex 1, , France
Richmond, Virginia, United States
Sao Paulo, , Brazil
Shenyang, , China
Ankara, , Turkey
Helsingborg, , Sweden
São Paulo, , Brazil
São Paulo, , Brazil
Kota Kinabalu, , Malaysia
Chesterfield, Missouri, United States
Camden, New Jersey, United States
Fu Zhou, , China
Tian Jin, , China
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Szczecin, , Poland
Herning, , Denmark
Beijing, , China
Chengdu, , China
Shenzhen, , China
Caen Cedex 9, , France
Montpellier, , France
Vandœuvre Lès Nancy, , France
Dresdden, , Germany
Leipzig, , Germany
Tel Aviv Yafo, , Israel
Chiba, , Japan
Kamogawa City, , Japan
Tokyo, , Japan
Georgetown, , Malaysia
Vila Nova De Gaia, , Portugal
Barcelona, , Spain
Valencia, , Spain
Falun, , Sweden
Linköping, , Sweden
Ankara, , Turkey
Istanbul, , Turkey
Middlesborough, , United Kingdom
Staffordshire, , United Kingdom
Brasília, , Brazil
Sao Jose Do Rio Preto, , Brazil
Sao Paulo, , Brazil
Rio De Janeiro, , Brazil
São José Do Rio Preto, , Brazil
Brasilia, , Brazil
Joinville, , Brazil
Curitiba, , Brazil
Brasilia, , Brazil
Temple, Texas, United States
Steyr, , Austria
Sao Jose Do Rio Preto, , Brazil
Patra, , Greece
Thessaloniki, , Greece
Rio De Janeiro, , Brazil
Yamagata, , Japan
Niteroi, , Brazil
Sao Paulo, , Brazil
Hospitalet De Llobregat, , Spain
Boise, Idaho, United States
Sao Paulo, , Brazil
Shanghai, , China
Herning, Vælg Provins, Denmark
Caxias Do Sul, , Brazil
Caxias Do Sul, , Brazil
Sao Jose Do Rio Preto, , Brazil
Joinville, , Brazil
Kamogawa City, , Japan
Leon, , Spain
Herning, , Denmark
Long Beach, California, United States
Beijing, , China
Vandœuvre Lès Nancy, , France
Wuxi, , China
Sao Paulo, , Brazil
Natal, , Brazil
Niteroi, , Brazil
Sao Paulo, , Brazil
Thessaloniki, , Greece
Lublin, , Poland
Kashiwa, , Japan
Tokyo, , Japan
Lancaster, Pennsylvania, United States
Siena, , Italy
Vienna, , Austria
Ankara, , Turkey
Bologna, , Italy
Osaka, , Japan
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Chengdu, , China
Thessaloniki, , Greece
Fort Belvoir, Virginia, United States
Niigata, , Japan
Shanghai, , China
Metairie, Louisiana, United States
Tian Jin, , China
Roma, , Italy
Bunkyo Ku, , Japan
New York, New York, United States
Joinville, , Brazil
Guangzhou, , China
Montreal, Quebec, Canada
Sao Paulo, , Brazil
Chesterfield, Missouri, United States
Montpellier, , France
Cottbus, , Germany
Kamogawa City, , Japan
Curitiba, , Brazil
Katowice, , Poland
Des Moines, Iowa, United States
Hirakata, , Japan
Bunkyo Ku, , Japan
Braga, , Portugal
Calgary, Alberta, Canada
Sao Jose Do Rio Preto, , Brazil
Sao Paulo, , Brazil
Almada, , Portugal
Calgary, Alberta, Canada
Sao Paulo, , Brazil
Vila Nova De Gaia, , Portugal
Gdansk, , Poland
Kielce, , Poland
Yamagata, , Japan
Hospitalet De Llobregat, , Spain
Paris, , France
Sao Paulo, , Brazil
Waukee, Iowa, United States
Aurora, Colorado, United States
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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