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 safety and toxicity of etentamig (ABBV-383) when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), or daratumumab-dexamethasone (Dd), in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity 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. Etentamig co-administered with Pd, Rd, or Dd, will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of etentamig, followed by a dose expansion phase to confirm the dose. Approximately 320 adult participants with R/R MM will be enrolled in the study in approximately 48 sites worldwide. Participants will receive intravenous (IV) etentamig co-administered with oral/IV Pd, oral/IV Rd, or oral/IV/subcutaneous (SC) Dd in 28-day cycles. 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 side effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
283
Intravenous (IV) Infusion
Oral; Tablet or IV Infusion
Oral; Capsule
Oral; Capsule
Subcutaneous Injection (SC)
University of Arkansas for Medical Sciences /ID# 243096
Little Rock, Arkansas, United States
Sylvester Comprehensive Cancer Center /ID# 243673
Miami, Florida, United States
Moffitt Cancer Center /ID# 243437
Tampa, Florida, United States
University of Maryland, Baltimore /ID# 243679
Baltimore, Maryland, United States
Dana-Farber Cancer Institute /ID# 249529
Boston, Massachusetts, United States
Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig
DLT events as described in the protocol will be assessed.
Time frame: Up to approximately 28 Days
Number of Participants with Adverse Events (AEs)
An AE 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. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Up to Approximately 3 Years
Overall Response Rate (ORR)
ORR is defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR); proportion of participants who achieved a PR or better.
Time frame: Up to Approximately 3 Years
Progression-Free Survival (PFS)
PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.
Time frame: Up to Approximately 3 Years
Duration of Response (DOR)
DOR will be 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 frame: Up to Approximately 3 Years
Time-to-Progression (TTP)
TTP is defined as the number of days from the date of first dose to the date of earliest disease progression.
Time frame: Up to Approximately 3 Years
Percentage of Participants with Minimal Residual Diseas (MRD) Negativity by Next-Generation Sequencing (NGS)
MRD negative status (threshold as assessed by NGS Adaptive Clonoseq) with \>= CR (per International Myeloma Working Group \[IMWG\] response criteria) prior to the initiation of new myeloma therapy.
Time frame: Up to Approximately 3 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Massachusetts - Worcester /ID# 243977
Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438
Ann Arbor, Michigan, United States
The Valley Hospital /ID# 243829
Paramus, New Jersey, United States
Rutenberg Cancer Center /ID# 244647
New York, New York, United States
Memorial Sloan Kettering Cancer Center /ID# 244656
New York, New York, United States
...and 39 more locations