Clinical trial NCT06892522: A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib
Official title: A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma, Etentamig, ABBV-383, Cancer
Daratumumab
Lenalidomide
Dexamethasone
Carfilzomib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-03-24
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, and pharmacokinetics of Etentamig in adult participants with MM.

Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide

In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 months.

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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.


Eligibility criteria: Inclusion Criteria:

* Eastern cooperative oncology group (ECOG) performance of \<= 1.
* Confirmed diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) diagnostic criteria with either newly diagnosed or relapsed or refractory (RR) MM, depending on the substudy.

Exclusion Criteria:

* Participant who has known active central nervous system involvement of MM.
* Participant who has known active infection as outlined in the protocol.

Primary outcomes:
measure: Number of Participants with Adverse Events (AE)s
timeFrame: Up to Approximately 130 Months
measure: Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)
timeFrame: Up to Approximately 8 weeks
measure: Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM)
timeFrame: Up to Approximately 8 Weeks
measure: Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM)
timeFrame: Up to Approximately 8 Weeks
measure: Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM
timeFrame: Up to Approximately 8 Weeks
Secondary outcomes:
measure: Substudy 1, 2, 3, 4: Complete Response Rate
timeFrame: Up to Approximately 1 Year
measure: Substudy 1, 2, 3, 4: Overall Response Rate (ORR)
timeFrame: Up to Approximately 1 Year
measure: Substudy 1, 2, 3, 4: Progression Free Survival (PFS)
timeFrame: Up to Approximately 130 Months
measure: Substudy 1, 2, 3, 4: Duration of Response (DOR)
timeFrame: Up to Approximately 130 Months
measure: Substudy 1, 2, 3, 4: Time-to-Progression (TTP)
timeFrame: Up to Approximately 130 Months
measure: Substudy 1, 2, 3, 4: Minimal Residual Disease (MRD) negativity
timeFrame: Up to Approximately 52 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: