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This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cemsidomide + Dexamethasone: | Experimental | Participants receive cemsidomide plus dexamethasone during a 28-day treatment cycle, and will continue to receive treatment until the participant meets one of the discontinuation criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cemsidomide | Drug | dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC) | up to approximately 43 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DoR; IRC assessed) | up to approximately 43 months | |
| Complete response (CR) rate (IRC assessed) | up to approximately 43 months | |
| Time to response (IRC assessed) |
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Inclusion Criteria:
Exclusion Criteria:
Presence of myeloma in the central nervous system (CNS).
Subjects with any of the following:
Previously treated with cemsidomide.
Clinically significant impaired cardiac function or cardiac disease.
Thromboembolic event within 3 months prior to enrollment.
Known malignancy other than study indication that has progressed or required treatment within the past 3 years.
Uncontrolled active bacterial, fungal, or viral infection.
Inability or difficulty swallowing tablets.
NOTE: Other inclusion/exclusion criteria may apply, per protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Medical Officer | Contact | (617) 231-0700 | clinicaltrials@c4therapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Binod Dhakal, M.D. | Medical College of Wisconsin | Principal Investigator |
| Martin Kaiser, M.D. | The Royal Marsden | Principal Investigator |
| Aurore Perrot, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Recruiting | Scottsdale | Arizona | 85258 | United States |
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| Dexamethasone | Drug | dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle |
|
| up to approximately 43 months |
| Progression free survival (PFS; IRC assessed) | up to approximately 43 months |
| Overall survival (OS) | up to approximately 43 months |
| Adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths | within 30 to 35 days of the last dose of study treatment |
| Plasma concentrations of cemsidomide | up to approximately 4 months |
| Universite de Toulouse |
| Principal Investigator |
| Berenson Cancer Center | Recruiting | West Hollywood | California | 90069 | United States |
|
| Winship Cancer Institute, Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Indiana University Health | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
|
| Washington University/Siteman Cancer Center | Recruiting | St Louis | Missouri | 63108 | United States |
|
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| START San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| University of Wisconsin - Carbone Cancer Center | Recruiting | Madison | Wisconsin | 53792 | United States |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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