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The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma.
The first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity.
Cemsidomide will be taken orally each cycle for 14 days on/14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cemsidomide | Drug | IKZF1/3 degrader |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of cemsidomide in combination with elranatamab | Dose limiting toxicity rate | Cycle 1 approximately 28 days |
| Safety and tolerability of cemsidomide in combination with elranatamab | Frequency and severity of AEs | Baseline through 30 days after discontinuation of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assess antimyeloma activity | Objective Response Rate (ORR) per IMWG criteria | Approximately 2 years |
| Evaluate the PK of cemsidomide and elranatamab | Pre and post dose concentrations of cemsidomide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Medical Officer | Contact | (617) 231-0700 | clinicaltrials@c4therapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Not yet recruiting | Gilbert | Arizona | 85234 | United States | |
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| Elranatamab | Biological | • BCMA-CD3 bispecific antibody |
|
|
| Approximately 4 months |
| Evaluate the PK of cemsidomide and elranatamab | Pre dose concentrations of elranatamab | Approximately 2 years |
| Assess the immunogenicity of elranatamab | Percent of participants with positive anti-drug antibodies to elranatamab | Approximately 2 years |
| UCLA Health, Jonsson Comprehensive Cancer Center |
| Not yet recruiting |
| Santa Monica |
| California |
| 90404 |
| United States |
| Tampa General Hospital | Not yet recruiting | Tampa | Florida | 33606 | United States |
| Winship Cancer Institute, Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
| Loyola University Medical Center | Not yet recruiting | Maywood | Illinois | 60153 | United States |
| Indiana University | Not yet recruiting | Indianapolis | Indiana | 46202 | United States |
| Norton Cancer Institute St. Matthews | Not yet recruiting | Louisville | Kentucky | 40207 | United States |
| University of Maryland Greenbaum Comprehensive Cancer Center | Not yet recruiting | Baltimore | Maryland | 21201 | United States |
| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| University of Nebraska | Not yet recruiting | Omaha | Nebraska | 68105 | United States |
| Dartmouth-Hitchcock Medical Center | Not yet recruiting | Lebanon | New Hampshire | 03756 | United States |
| Perlmutter Cancer Center at NYU Langone Hospital | Not yet recruiting | Brooklyn | New York | 11203 | United States |
| Memorial Sloan Kettering Cancer Center | Not yet recruiting | New York | New York | 10021 | United States |
| Duke Cancer Center | Not yet recruiting | Durham | North Carolina | 27710 | United States |
| MD Anderson Cancer Center | Not yet recruiting | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute, University of Utah | Not yet recruiting | Salt Lake City | Utah | 84112 | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| D001733 | Bites and Stings |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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