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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1210-6325 | Registry Identifier | WHO | |
| 2023-506564-14 | Other Identifier | EU CTR |
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Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.
The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of CC-93269 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-93269 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Number of participants with Adverse Events | Up to approximately 63 months |
| Dose Limiting Toxicity (DLT) | Is defined as any of the toxicities occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes. | Up to 60 months |
| Non-Tolerated Dose (NTD) | Is defined as a dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in the DLT window. | Up to 60 months |
| Maximum Tolerated Dose (MTD) | Is defined as the last dose cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the DLT window. | Up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Is defined as the proportion of subjects who achieve a partial response or better (eg, PR, VGPR, CR or sCR), according to International Myeloma Working Group (IMWG) response criteria. | Up to 60 months |
| Time to Response |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 105 | Birmingham | Alabama | 35294 | United States | ||
| Local Institution - 103 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).
| Up to 60 months |
| Duration of Response | Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first. | Up to 60 months |
| Progression Free Survival | Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first. | Up to 60 months |
| Overall Survival | Is defined as the time from the first dose of CC-93269 to death from any cause. | Up to 60 months |
| Pharmacokinetics - Cmax | Maximum serum concentration of drug | Up to 60 months |
| Pharmacokinetics - Cmin | Minimum serum concentration of drug | Up to 60 months |
| Pharmacokinetics - AUC | Area under the curve | Up to 60 months |
| Pharmacokinetics - tmax | Time to peak (maximum) serum concentration | Up to 60 months |
| Pharmacokinetics - t1/2 | Terminal Half-life | Up to 60 months |
| Pharmacokinetics - CL | Apparent total body clearance | Up to 60 months |
| Pharmacokinetics - Vss | Volume of distribution at steady-state | Up to 60 months |
| Pharmacokinetics - accumulation index of alnuctamab | Accumulation ratio of drug | Up to 60 months |
| Presence and frequency of anti-drug antibodies (ADA) | Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies | Up to 60 months |
| San Francisco |
| California |
| 94143 |
| United States |
| Local Institution - 107 | New Haven | Connecticut | 06510 | United States |
| Local Institution - 106 | Atlanta | Georgia | 30322 | United States |
| Local Institution - 109 | Boston | Massachusetts | 02114 | United States |
| Local Institution - 111 | Boston | Massachusetts | 02215 | United States |
| Henry Ford Medical Center - New Center One | Detroit | Michigan | 48202 | United States |
| Icahn School of Medicine at Mount Sinai Mount Sinai West | New York | New York | 10019 | United States |
| Local Institution - 101 | Seattle | Washington | 98104 | United States |
| Local Institution - 305 | Erlangen | 91054 | Germany |
| Local Institution - 303 | Hamburg | 20246 | Germany |
| Local Institution - 302 | Heidelberg | 69120 | Germany |
| Local Institution - 306 | München | 81675 | Germany |
| Local Institution - 304 | Tübingen | 72076 | Germany |
| Local Institution - 402 | Bergamo | 24127 | Italy |
| Local Institution - 403 | Meldola | 47014 | Italy |
| Local Institution - 401 | Milan | 20089 | Italy |
| Local Institution - 602 | Nagoya | Aichi-ken | 4678602 | Japan |
| Local Institution - 603 | Shibuya-ku | Tokyo | 1508935 | Japan |
| Local Institution - 605 | Kamakura | 247-8533 | Japan |
| Local Institution - 604 | Kashiwa | 277-8577 | Japan |
| Local Institution - 601 | Kyoto | 602-8566 | Japan |
| Local Institution - 206 | Barcelona | 08916 | Spain |
| Local Institution - 208 | Barcelona | 8035 | Spain |
| Local Institution - 205 | Madrid | 28007 | Spain |
| Local Institution - 201 | Pamplona | 31008 | Spain |
| Local Institution - 203 | Salamanca | 37007 | Spain |
| Local Institution - 204 | Santander | 39008 | Spain |
| Local Institution - 207 | Valencia | 46009 | Spain |
| Local Institution - 202 | Valencia | 46017 | Spain |
| Local Institution - 504 | Gothenborg | 413 46 | Sweden |
| Local Institution - 502 | Lund | SE-221 85 | Sweden |
| Local Institution - 501 | Stockholm | 141 86 | Sweden |
| Local Institution - 505 | Uppsala | 75158 | Sweden |
| 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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