Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522090-11 | Other Identifier | EU CTR | |
| U1111-1317-4901 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 | Experimental |
| |
| Phase 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elranatamab | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer | |
| Number of participants with Serious AEs | From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer | |
| Number of participants with AEs meeting protocol-defined DLT criteria | From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer | |
| Number of participants with AEs leading to discontinuation | From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer | |
| Number of deaths | From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer | |
| Recommended Phase 2 Dose (RP2D) | From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR) | From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years) | |
| IMWG Uniform Response Criteria: Complete Response Rate (CRR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mezigdomide | Drug | Specified dose on specified days |
|
|
| Dexamethasone | Drug | Specified dose on specified days |
|
|
| From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years) |
| IMWG Uniform Response Criteria: Very Good Partial Response Rate (VGPRR) | From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years) |
| IMWG Uniform Response Criteria: Time to Response (TTR) | From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years) |
| IMWG Uniform Response Criteria: Duration of Response (DOR) | From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years) |
| IMWG Uniform Response Criteria: Progression-free Survival (PFS) | From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years) |
| IMWG Uniform Response Criteria: Overall Survival (OS) | From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years) |
| Number of participants who achieve minimal residual disease (MRD) negativity | Defined as less than 1 in 10^5 nucleated cells in BMA for participants who achieve CR or better at any time after enrollment | From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years) |
| Yale New Haven Hospital-Smilow Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
|
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| Arthur J E Child Comprehensive Cancer Centre | Recruiting | Calgary | Alberta | T2N 5G2 | Canada |
|
| Local Institution - 0026 | Not yet recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
|
| QEII Health Sciences Centre - Victoria General Site | Recruiting | Halifax | Nova Scotia | B3H 2Y9 | Canada |
|
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
|
| Local Institution - 0030 | Not yet recruiting | Suzhou | Jiangsu | 215006 | China |
|
| Local Institution - 0031 | Not yet recruiting | Shanghai | Shanghai Municipality | 200434 | China |
|
| Universitaetsklinikum Carl Gustav Carus Dresden | Recruiting | Dresden | 01307 | Germany |
|
| Universitaetsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
|
| Universitaetsklinikum Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
|
| Evangelismos General Hospital of Athens | Recruiting | Athens | Attikí | 106 76 | Greece |
|
| Alexandra General Hospital of Athens | Recruiting | Athens | Attikí | 115 28 | Greece |
|
| St. Olavs Hospital | Recruiting | Trondheim | Sør-Trøndelag | 7030 | Norway |
|
| Sykehusapoteket Ull | Recruiting | Oslo | 0450 | Norway |
|
| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | Cantabria | 39008 | Spain |
|
| Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca | Recruiting | Salamanca | 37007 | Spain |
|
| University College London Hospital | Recruiting | London | England | W1T 7HA | United Kingdom |
|
| Royal Marsden Hospital (Sutton) | Recruiting | London | Sutton | SM2 5PT | United Kingdom |
|
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided