A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)

Description

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity of surzetoclax in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. Surzetoclax is an investigational drug being developed for the treatment of R/R MM. In Substudy 1 there will be dose escalation and dose expansion phases where participants will receive various doses (escalation) or 1 of 2 doses (expansion) of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax. In Substudy 2, there will be a dose escalation phase where participants will receive various doses of surzetoclax alone. In Substudy 3 there will be dose escalation and optimization phases where participants will receive various doses (escalation) or 1 of 2 doses (optimization) of of surzetoclax and etentamig to determine the best dose of surzetoclax and etentamig. Optimization will also include etentamig received alone. Approximately 325 adult participants with R/R MM will be enrolled in the study in approximately 55 sites worldwide. In Substudy 1 escalation phase, participants will receive oral surzetoclax tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive 1 of 2 doses oral surzetoclax tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral surzetoclax tablets. In Substudy 3 escalation phase, participants will receive oral surzetoclax tablets in combination with IV etentamig and in the expansion phase, will receive 1 of 2 doses of both oral surzetoclax tablets in combination with of IV etentamig, or IV etentamig alone. The total study duration is approximately 4.5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

Interventions

• Surzetoclax (Drug)
  Oral
• Daratumumab (Drug)
  Subcutaneous (SC) Injection
• Dexamethasone (Drug)
  Oral
• Pomalidomide (Drug)
  Oral
• Etentamig (Drug)
  Intravenous Infusion

Eligibility criteria

Conditions

Locations

• University of Southern California /ID# 272414 — Los Angeles, California, United States
• Yale University School of Medicine /ID# 272447 — New Haven, Connecticut, United States
• Dana-Farber Cancer Institute /ID# 271846 — Boston, Massachusetts, United States
• University of Michigan Health System - Ann Arbor /ID# 271536 — Ann Arbor, Michigan, United States
• Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214 — New York, New York, United States
• Atrium Health Levine Cancer Institute /ID# 271510 — Charlotte, North Carolina, United States
• University Of North Carolina Health Care - Hillsborough Campus /ID# 272454 — Hillsborough, North Carolina, United States
• Atrium Health Wake Forest Baptist Medical Center /ID# 271294 — Winston-Salem, North Carolina, United States
• Oregon Health and Science University /ID# 272282 — Portland, Oregon, United States
• University of Texas - Southwestern Medical Center /ID# 271914 — Dallas, Texas, United States
• Huntsman Cancer Institute /ID# 271618 — Salt Lake City, Utah, United States
• Northwest Medical Specialties Tacoma /ID# 272506 — Tacoma, Washington, United States
• Liverpool Hospital /ID# 272002 — Liverpool, New South Wales, Australia
• Calvary Mater Newcastle /ID# 272498 — Waratah, New South Wales, Australia
• St Vincent's Hospital - Melbourne /ID# 271997 — Fitzroy, Victoria, Australia
• Epworth HealthCare /ID# 272497 — Richmond, Victoria, Australia
• UZ Gent /ID# 271432 — Ghent, Oost-Vlaanderen, Belgium
• Universitair Ziekenhuis Leuven /ID# 272382 — Leuven, Vlaams-Brabant, Belgium
• CHU de Liege /ID# 271430 — Liège, Belgium
• CHU de Montpellier - Hopital Saint Eloi /ID# 275570 — Montpellier, Herault, France
• Centre Hospitalier Universitaire de Poitiers /ID# 275563 — Poitiers, New Aquitaine, France
• IUCT Oncopole /ID# 275568 — Toulouse, Occitanie, France
• Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 275562 — Nantes, Pays de la Loire Region, France
• Hopital Universitaire Necker Enfants Malades /ID# 275571 — Paris, Île-de-France Region, France
• Universitaetsklinikum Heidelberg /ID# 275598 — Heidelberg, Baden-Wurttemberg, Germany
• Klinikum der Universitaet Muenchen Grosshadern /ID# 276658 — Munich, Bavaria, Germany
• Universitaetsklinikum Wuerzburg /ID# 276657 — Würzburg, Bavaria, Germany
• Universitaetsklinikum Hamburg-Eppendorf /ID# 275803 — Hamburg, Germany
• Rabin Medical Center. /ID# 272073 — Petah Tikva, Central District, Israel
• The Chaim Sheba Medical Center /ID# 271251 — Ramat Gan, Tel Aviv, Israel
• Tel Aviv Sourasky Medical Center /ID# 271252 — Tel Aviv, Tel Aviv, Israel
• Rambam Health Care Campus- Haifa /ID# 271256 — Haifa, Israel
• Hadassah Medical Center-Hebrew University /ID# 271253 — Jerusalem, Israel
• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 276306 — Milan, Italy
• Nagoya City University Hospital /ID# 271427 — Nagoya, Aichi-ken, Japan
• University Hospital Kyoto Prefectural University of Medicine /ID# 271911 — Kyoto, Kyoto, Japan
• The University of Osaka Hospital /ID# 271636 — Suita-shi, Osaka, Japan
• Japanese Red Cross Medical Center /ID# 272018 — Shibuya-ku, Tokyo, Japan
• The Jikei University Hospital /ID# 272091 — Tokyo, Japan
• Uniwersytecki Szpital Kliniczny w Poznaniu - Szamarzewskiego /ID# 276237 — Poznan, Greater Poland Voivodeship, Poland
• Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie /ID# 276052 — Lublin, Lublin Voivodeship, Poland
• Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 276352 — Lublin, Lublin Voivodeship, Poland
• Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 276263 — Warsaw, Masovian Voivodeship, Poland
• Instituto Portugues de Oncologia de Lisboa Francisco Gentil /ID# 275873 — Lisbon, Lisbon District, Portugal
• Unidade Local de Saude de Braga, EPE /ID# 275853 — Braga, Portugal
• Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 275851 — Porto, Portugal
• Karolinska Universitetssjukhuset - Huddinge /ID# 271674 — Huddinge, Stockholm County, Sweden
• Sodra Alvsborgs sjukhus /ID# 271822 — Borås, Västra Götaland County, Sweden
• Sahlgrenska Universitetssjukhuset /ID# 272448 — Gothenburg, Västra Götaland County, Sweden
• The Christie NHS Foundation Trust - Christie Hospital /ID# 276276 — Manchester, United Kingdom