Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, BCMA X CD3 T Cell, Antibody, CC-93269, Relapsed and Refractory
Brief summary
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.
Detailed description
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.
Interventions
DRUGCC-93269
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of multiple myeloma with relapsed and refractory disease * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Must have measurable disease as determined by the central laboratory
Exclusion criteria
* Symptomatic central nervous system involvement of multiple myeloma * Prior autologous stem cell transplant ≤ 3 months prior * Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior * History of concurrent second cancers requiring active, ongoing systemic treatment Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Up to approximately 63 months | Number of participants with Adverse Events |
| Dose Limiting Toxicity (DLT) | Up to 60 months | 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. |
| Non-Tolerated Dose (NTD) | Up to 60 months | 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. |
| Maximum Tolerated Dose (MTD) | Up to 60 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 60 months | Is defined as the time from the first dose of CC-93269 to death from any cause. |
| Pharmacokinetics - Cmax | Up to 60 months | Maximum serum concentration of drug |
| Pharmacokinetics - Cmin | Up to 60 months | Minimum serum concentration of drug |
| Pharmacokinetics - AUC | Up to 60 months | Area under the curve |
| Pharmacokinetics - tmax | Up to 60 months | Time to peak (maximum) serum concentration |
| Overall Response Rate (ORR) | Up to 60 months | 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. |
| Pharmacokinetics - CL | Up to 60 months | Apparent total body clearance |
| Pharmacokinetics - Vss | Up to 60 months | Volume of distribution at steady-state |
| Pharmacokinetics - accumulation index of alnuctamab | Up to 60 months | Accumulation ratio of drug |
| Presence and frequency of anti-drug antibodies (ADA) | Up to 60 months | Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies |
| Pharmacokinetics - t1/2 | Up to 60 months | Terminal Half-life |
| Time to Response | Up to 60 months | Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better). |
| Duration of Response | Up to 60 months | Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first. |
| Progression Free Survival | Up to 60 months | Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first. |
Countries
Germany, Italy, Japan, Spain, Sweden, United States
Outcome results
None listed