Multiple Myeloma Clinical Trial
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
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).
Full 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.
Eligibility Criteria
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
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There are 208 Locations for this study
Tucson Arizona, 85719, United States
Little Rock Arkansas, 72205, United States
Duarte California, 91010, United States
San Francisco California, 94143, United States
Norwalk Connecticut, 06850, United States
Washington District of Columbia, 20007, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30303, United States
Chicago Illinois, 60612, United States
Iowa City Iowa, 52242, United States
Westwood Kansas, 66205, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21205, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02118, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48109, United States
Minneapolis Minnesota, 55455, United States
Jackson Mississippi, 39216, United States
Saint Louis Missouri, 63110, United States
New Brunswick New Jersey, 08903, United States
Buffalo New York, 14263, United States
New York New York, 10016, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28204, United States
Charlotte North Carolina, 28204, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43214, United States
Philadelphia Pennsylvania, 19107, United States
Memphis Tennessee, 38120, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Richmond Virginia, 23219, United States
Seattle Washington, 98109, United States
Madison Wisconsin, 53792, United States
Brussel , 1090, Belgium
Edegem , 2650, Belgium
Hasselt , 3500, Belgium
Liège , 4000, Belgium
Ottignies , 1340, Belgium
Yvoir , 5530, Belgium
Brasilia , 70390, Brazil
Caxias do Sul , 95070, Brazil
Curitiba , 81520, Brazil
Florianopolis , 88034, Brazil
Natal , 59062, Brazil
Porto Alegre , 90050, Brazil
Ribeirão Preto , 14051, Brazil
Rio de Janeiro , 22250, Brazil
Rio de Janeiro , 22775, Brazil
Salvador , 41253, Brazil
Sao Paulo , 01236, Brazil
Sao Paulo , 01509, Brazil
São Paulo , 01308, Brazil
São Paulo , 01321, Brazil
São Paulo , 01455, Brazil
São Paulo , 45010, Brazil
Beijing , 10000, China
Beijing , 10002, China
Beijing , 10003, China
Changchun , 13002, China
ChangSha , 41000, China
Chengdu , 61007, China
Chongqing , 40003, China
Fuzhou , 35000, China
Guangzhou , 51006, China
Guangzhou , 51008, China
Hangzhou , 31000, China
Nanjing , 21000, China
Shanghai , 20006, China
Shanghai , 20043, China
Shenzhen , 51803, China
Su Zhou , 21500, China
Tianjin , 30006, China
Tianjin , 30032, China
Wuhan , 43003, China
Xi' An , 71006, China
Zhengzhou , 45000, China
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Ostrava , 70852, Czechia
Praha 10 , 100 3, Czechia
Praha 2 , 128 0, Czechia
Creteil , 94010, France
Dijon , 21000, France
Lyon , 69008, France
Montpellier Cedex 5 , 34295, France
Nantes , 44093, France
Nice N/a , 06202, France
Paris Cedex 12 , 75571, France
Pessac , 33604, France
Rennes , 35000, France
TOULOUSE Cedex 9 , 31059, France
Berlin , 12203, Germany
Essen , D-451, Germany
Hamburg , 22763, Germany
Heidelberg , 69120, Germany
Koeln , 50937, Germany
Leipzig , 04103, Germany
Mainz , 55131, Germany
Munchen , 81675, Germany
Wuerzburg , 97080, Germany
Athens Attica , 115 2, Greece
Athens , 106 7, Greece
Thessalonikis , 570 1, Greece
Thessaloniki , 546 3, Greece
Haifa , 31048, Israel
Haifa , 31096, Israel
Haifa , 34362, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Nahariya , 22100, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Safed , 13100, Israel
Tel Aviv , 64239, Israel
Ancona , 60126, Italy
Bari , 70124, Italy
Bologna , 40138, Italy
Brescia , 25123, Italy
Catania , 95123, Italy
Milano , 20133, Italy
Milano , 20162, Italy
Padova , 35128, Italy
Palermo , 90146, Italy
Pavia , 27100, Italy
Reggio Emilia , 42123, Italy
Roma , 00193, Italy
San Giovanni Rotondo , 71013, Italy
Torino , 10126, Italy
Chiba , 260-8, Japan
Gifu , 503-8, Japan
Gunma , 371-0, Japan
Hirakata , 573-1, Japan
Hyôgo , 663-8, Japan
Kamakura-shi , 247-8, Japan
Kashiwa , 277-8, Japan
Koshigaya , 343-8, Japan
Kumamoto , 860-8, Japan
Kyoto , 603-8, Japan
Matsumoto , 399-8, Japan
Niigata , 951-8, Japan
Sapporo-shi , 060-8, Japan
Sendai , 980-8, Japan
Shiwa-gun , 028-3, Japan
Suita-shi , 565-0, Japan
Tokyo , 135-8, Japan
Busan , 602-8, Korea, Republic of
Gyeonggi-do , 10408, Korea, Republic of
Incheon , 21565, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Jeonju-si , 54907, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Den-Haag , 2545 , Netherlands
Dordrecht , 3318 , Netherlands
Eindhoven , 5631 , Netherlands
Maastricht , 6229 , Netherlands
Rotterdam , 3015 , Netherlands
Brzozow , 36-20, Poland
Gdansk , 80-21, Poland
Katowice , 40-51, Poland
Kielce , 25-73, Poland
Krakow , 31-50, Poland
Lublin , 20090, Poland
Olsztyn , 10-22, Poland
Warszawa , 02-78, Poland
Wroclaw , 50-36, Poland
Badalona , 08916, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
El Palmar, Murcia , 30120, Spain
Jerez de la Frontera , 11407, Spain
Leon , 24071, Spain
Madrid , 28006, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Salamanca , 37007, Spain
San Cristóbal de La Laguna , 38320, Spain
Valencia , 46017, Spain
Kaohsiung , 80756, Taiwan
Kaohsiung , 83301, Taiwan
Taichung City , 40447, Taiwan
Tainan , 704, Taiwan
Taipei , 10048, Taiwan
Taipei , 112, Taiwan
Ankara , 06200, Turkey
Ankara , 06590, Turkey
Istabul , 34214, Turkey
Istanbul , 34093, Turkey
Istanbul , 34098, Turkey
Izmir , 35330, Turkey
Samsun , 55139, Turkey
Blackpool , FY3 8, United Kingdom
Dundee , DD1 9, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
Nottingham , NG5 1, United Kingdom
Plymouth , PL6 8, United Kingdom
Sheffield , S10 2, United Kingdom
Sutton , SM2 5, United Kingdom
Wolverhampton , WV10 , United Kingdom
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