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| ID | Type | Description | Link |
|---|---|---|---|
| MagnetisMM-30 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide.
There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma.
Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement.
All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle.
Participants will receive study medicine until:
The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Dose Escalation | Experimental | Non-randomized elranatamab plus iberdomide |
|
| Part 2 Dose Randomization | Experimental | Randomized elranatamab plus iberdomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elranatamab | Drug | BCMA-CD3 bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of participants with dose limiting toxicity (DLT) | Dose limiting toxicity rate based on dose limiting toxicity evaluable participants | Cycle 1, about 28 days |
| Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment | Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator. | Assessed from baseline up to 90 days after last dose of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment | Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator. | Assessed from baseline up to 90 days after last dose of study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center | Recruiting | Coral Gables | Florida | 33146 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Iberdomide | Drug | cereblon-modulating agent |
|
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| Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibly of causal relationship | Assessed from baseline up to 90 days after last dose of study treatment |
| Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities | Laboratory abnormalities as characterized by type, frequency, severity | Assessed from baseline up to 90 days after last dose of study treatment |
| Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR) | Percent of participants having confirmed Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) per IMWG criteria as determined by investigator | Assessed for approximately 2 years |
| Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR) | Percent of participants having Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria as determined by investigator | Assessed for approximately 2 years |
| Part 1 and Part 2: Time to Response (TTR) | For participants with an objective response per IMWG criteria, TTR is the time from first dose to the first documentation of objective response that is subsequently confirmed | Assessed for approximately 2 years |
| Part 1 and Part 2: Duration of Response (DOR) | For participants with an objective response per IMWG criteria, DOR is the time from first documentation of objective response that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria | Assessed for approximately 2 years |
| Part 1 and Part 2: Duration of Complete Response (DOCR) | For participants with a Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria, DOCR is the time from the first documentation of CR/sCR that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria | Assessed for approximately 2 years |
| Part 1 and Part 2: Time of Progression Free Survival (PFS) | Progression free survival (IMWG criteria) | Assessed for approximately 2 years |
| Part 1 and Part 2: Time of Overall Survival (OS) | The duration of time from first dose of study treatment to death | Assessed for approximately 2 years |
| Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate | The proportion of participants achieving CR+sCR with negative MRD per IMWG sequencing criteria, from the date of first dose until the first documentation of confirmed progressive disease (PD), death, or start of new anticancer therapy. | Assessed for approximately 2 years |
| Part 1 and Part 2: Concentrations of elranatamab | Pre-dose and post-dose concentrations of elranatamab | Assessed for approximately 2 years |
| Part 1 and Part 2: Concentrations of iberdomide | Pre-dose concentrations of iberdomide | Assessed for approximately 4 months |
| Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab | Percent of participants with positive ADA to elranatamab when given in combination with iberdomide | Assessed for approximately 2 years |
| University of Miami Hospital and Clinics Deerfield Beach | Recruiting | Deerfield Beach | Florida | 33442 | United States |
| Sylvester Comprehensive Cancer Center- Doral | Recruiting | Doral | Florida | 33166 | United States |
| Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
| University of Miami Hospital and Clinics | Recruiting | Miami | Florida | 33136 | United States |
| Sylvester Comprehensive Cancer Center Kendall | Recruiting | Miami | Florida | 33176 | United States |
| Sylvester Comprehensive Cancer Center Plantation | Recruiting | Plantation | Florida | 33324 | United States |
| Emory University Hospital Midtown | Recruiting | Atlanta | Georgia | 30308 | United States |
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
| Indiana CTSI Clinical Research Center (ICRC) | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Indiana University Health University Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC) | Recruiting | Indianapolis | Indiana | 46202 | United States |
| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute - Chestnut Hill | Recruiting | Newton | Massachusetts | 02459 | United States |
| University of Massachusetts Chan Medical School | Recruiting | Worcester | Massachusetts | 01655 | United States |
| Methodist Hospital | Recruiting | Omaha | Nebraska | 68114 | United States |
| Oncology Hematology West P.C. dba Nebraska Cancer - Methodist | Recruiting | Omaha | Nebraska | 68114 | United States |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Recruiting | Omaha | Nebraska | 68130 | United States |
| Dartmouth Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
| MSK Basking Ridge | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
| MSK Monmouth | Recruiting | Middletown | New Jersey | 07748 | United States |
| MSK Bergen | Recruiting | Montvale | New Jersey | 07645 | United States |
| MSK Commack | Recruiting | Commack | New York | 11725 | United States |
| MSK Westchester | Recruiting | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy | Recruiting | Long Island City | New York | 11101 | United States |
| Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). | Recruiting | New York | New York | 10021 | United States |
| Memorial Sloan Kettering Cancer Center - Main Campus | Recruiting | New York | New York | 10065 | United States |
| MSK Nassau | Recruiting | Uniondale | New York | 11553 | United States |
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Liverpool Hospital | Recruiting | Liverpool | New South Wales | 2170 | Australia |
| Calvary Mater Newcastle | Recruiting | Waratah | New South Wales | 2298 | Australia |
| Townsville University Hospital | Recruiting | Douglas | Queensland | 4814 | Australia |
| Epworth Freemasons | Recruiting | East Melbourne | Victoria | 3002 | Australia |
| Epworth Hospital | Recruiting | Richmond | Victoria | 3121 | Australia |
| Slade Pharmacy | Recruiting | Richmond | Victoria | 3121 | Australia |
| Dr. Everett Chalmers Regional Hospital | Recruiting | Fredericton | New Brunswick | E3B 5N5 | Canada |
| CIUSSS de l'Est-de-l'Île-de-Montréal | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| 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 |
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| ID | Term |
|---|---|
| C000624220 | iberdomide |
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