ETENTAMIG for Multiple myeloma

Inclusion criteria

• {"criterion_text":"- Eastern cooperative oncology group (ECOG) performance of <= 1.\n- 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.\n- Laboratory values meeting the criteria outlined in the protocol for each substudy within the screening period prior to the first dose of study treatment."}

Exclusion criteria

• {"criterion_text":"- Participant who has known active central nervous system involvement of MM.\n- Participant who has known active infection as outlined in the protocol.\n- Participant who has known history or other active malignancies within the past 3 years with the exceptions listed in the protocol.\n- Participant who has known history of clinically significant (per investigator's judgment) alcohol abuse within the last 6 months."}

Primary endpoints

• {"endpoint_text":"- Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)\n- Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM\n- Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM)\n- Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM)\n- Number of Participants with Adverse Events (AE)s","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Substudy 1, 2, 3, 4: Complete Response Rate\n- Substudy 1, 2, 3, 4: Progression Free Survival (PFS)\n- Substudy 1, 2, 3, 4: Duration of Response (DOR)\n- Substudy 1, 2, 3, 4: Overall Response Rate (ORR)\n- Substudy 1, 2, 3, 4: Time-to-Progression (TTP)\n- Substudy 1, 2, 3, 4: Minimal Residual Disease (MRD) negativity","definition_or_measurement_approach":""}

Norway

Earliest CTIS Part Ii Submission Date

16-01-2026

Latest Decision Or Authorization Date

27-01-2026

Processing Time Days

11

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

IQVIA AG, Branch Basel

Responsibilities

3

Third parties

• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"15: ePROs","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"IQVIA AG, Branch Basel","duties_or_roles":"3","organisation_type":"Industry"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}