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| ID | Type | Description | Link |
|---|---|---|---|
| 1012518 | Other Identifier | IRAS |
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The purpose of this study is to learn more about the anti-cancer activity of inobrodib, when given in combination with pomalidomide and dexamethasone, in patients with multiple myeloma that has come back following treatment and which no longer responds to available therapies. The study treatment will not be compared to any other treatment and patients will know what treatment they are receiving. This study will also further explore the side effects of inobrodib in combination with these other medicines.
This is a Phase II, open-label, multicenter study to evaluate the efficacy and safety of inobrodib in combination with pomalidomide and dexamethasone (InoPd) in patients with relapsed and refractory multiple myeloma (RRMM).
Patients must be 18 years or older and be refractory to least one proteosome inhibitor (PI), one anti-CD38 monoclonal antibody (mAb) and pomalidomide. Patients must also be previously treated with an approved bispecific T-cell engager [TCE].
Approximately 100 patients will be treated with 20 mg of inobrodib administered orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle. Pomalidomide and dexamethasone will be administered as per standard of care (SoC), i.e., with a starting dose of 4 mg orally once daily on Day 1 to 21 of each 28-day cycle for pomalidomide, and 40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle for dexamethasone. Study treatment should be continued until disease progression, initiation of new anticancer therapy, unacceptable toxicity or the patient meets any criteria for withdrawal from the study.
The primary objective is to assess the efficacy of InoPd in terms of objective response rate (ORR) based on International Myeloma Working Group (IMWG) criteria and assessed by Independent Review Committee (IRC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inobrodib in combination with pomalidomide and dexamethasone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inobrodib | Drug | 20 mg orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate, defined as the percentage of patients with a confirmed partial response (PR) or better, based on IMWG criteria and assessed by Independent Review Committee (IRC) | Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR, defined as the percentage of patients with a confirmed PR or better, based on IMWG criteria assessed by Investigator | Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months) | |
| Duration of Response (DoR), defined as the duration of overall response by investigator and ICR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CCS1477-04 Clinical Operations | Contact | +44 1799 531130 | DOMMINO-1@cellcentric.com |
| Name | Affiliation | Role |
|---|---|---|
| Naseer Qayum | CellCentric Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States | |
The final clinical study report will be provided to the Investigators. The Sponsor will publicly disclose study results through posting on ClinicalTrials.gov and any other applicable public registries in accordance with local regulations.
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| Pomalidomide | Drug | 4 mg orally once daily on Day 1 to 21 of each 28-day cycle |
|
|
| Dexamethasone | Drug | 40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle |
|
| Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months) |
| Time to Response (TTR), defined as time to confirmed PR or better, by investigator and ICR | Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months) |
| Very Good Partial Response (VGPR) or better rate, defined as the percentage of patients with a confirmed VGPR or better, based on IMWG criteria and assessed by investigator and ICR | Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months) |
| Complete Response (CR) or better rate, defined as the percentage of patients with a confirmed CR or better, based on IMWG criteria and assessed by investigator and ICR | Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months) |
| Progression Free Survival (PFS), defined as the time from enrolment until the earliest date of Progressive Disease (PD), or death due to any cause, and assessed by investigator and ICR | Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months) |
| Overall Survival (OS), defined as the time from enrolment to the date of death due to any cause | Assessed from enrollment to date of death from any cause, until the end of study (up to 48 months) |
| Incidence of treatment-emergent adverse events (TEAEs), vital signs and laboratory abnormalities | Assessed from start of treatment until 28 days after end of treatment |
| H Lee Moffitt Cancer Center & Research Institute |
| Recruiting |
| Tampa |
| Florida |
| 33612 |
| United States |
| Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
| American Oncology Partners, PA | Recruiting | Bethesda | Maryland | 20817 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
| Rutgers Cancer Institute of New Jersey | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania, Abramson Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
| The Christie NHS Foundation Trust | Recruiting | Withington | Greater Manchester | M20 4BX | United Kingdom |
| Royal Marsden NHS Foundation Trust | Recruiting | Sutton | London | SM2 5PT | United Kingdom |
| University Hospital of Wales | Recruiting | Cardiff | Wales | CF14 4XW | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Recruiting | Bebington | Wirral | CH63 4JY | United Kingdom |
| Western General Hospital | Recruiting | Edinburgh | EH4 2XU | United Kingdom |
| Barts Health NHS Trust | Recruiting | London | EC1A 7BE | United Kingdom |
| King's College Hospital NHS Foundation Trust | Recruiting | London | SE5 9RS | United Kingdom |
| Imperial College Healthcare NHS Trust, Hammersmith Hospital | Recruiting | London | W12 0HS | United Kingdom |
| ID | Term |
|---|---|
| C000721532 | CCS1477 |
| C467566 | pomalidomide |
| 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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