Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Cereblon E3 Ligase Modulatory Drug, CELMoD, Iberdomide, Etentamig, ABBV-383
Brief summary
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed. Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide. In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.
Detailed description
B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.
Interventions
DRUGEtentamig
Intravenous (IV) Infusion
DRUGIberdomide
Oral Capsule
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1. * Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol. * All participants must have measurable diseases per central laboratory as outlined in protocol
Exclusion criteria
* Has received prior etentamig treatment. * Prior exposure to BCMA-targeted therapy as noted in the protocol. * Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) | Up to Approximately 56 Days | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. |
| Number of Participants with Adverse Events (AE)s | Up to Approximately 129 Months | An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial Response (PR) Response Rate (RR) | Up to 3 Years | PR is defined \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hours, if the serum and urine M-protein are unmeasurable, a \>= 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, if the serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, a \>= 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>= 30%, \>= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline. |
| Very Good Partial Response (VGPR) RR | Up to 3 Years | VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>= 90% reduction in serum M-protein plus urine M-protein \< 100 mg per 24 hours, for participants in whom the only measurable disease is by serum free light chains (FLC) levels, VGPR is defined as \>= 90% decrease in the difference between involved and uninvolved FLC levels. |
| Complete Response (CR) RR | Up to 3 Years | CR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in bone marrow, and for participants in whom the only measurable disease is by serum FLC levels, a normal FLC ratio is also required. |
| Stringent Complete Response (sCR) RR | Up to 3 Years | sCR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in bone marrow, normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry (kappa/lambda ratio \<= 4:1 or \>= 1:2 for kappa and lambda participants, respectively, after counting \>= 100 plasma cells). |
| Overall Response Rate (ORR) | Up to 3 Years | ORR (PR + VGPR + CR + sCR) will be defined as the proportion of participants who achieved a PR or better. |
| Progression-Free Survival (PFS) | Up to 3 Years | PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death. |
| Duration of Response (DOR) | Up to 3 Years | DOR is defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first. |
| Time-to-Progression (TTP) | Up to 3 Years | TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression. |
| Minimal Residual Disease (MRD) negativity | Up to 3 Years | The MRD negativity rate is defined as the proportion of participants who achieve MRD negative status. |
Countries
Australia, Canada, France, Japan, Netherlands, Norway, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed