A Phase 2/3 interventional study of Etentamig and Lenalidomide in Multiple Myeloma, sponsored by AbbVie. Recruiting at 49 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by AbbVie · Phase 2/3, Interventional, and Treatment
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. This is a study to determine the adverse events, change in disease activity, 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 2 phases; a phase 2 dose selection and optimization cohort with 3 study arms and a subcutaneous (SC) safety cohort with 2 study arms. Phase 3 participants will receive etentamig at recommended Phase 3 dose (RP3D). Around 680 adult participants with MM will be enrolled at approximately 155 sites worldwide
Participants in the phase 2 dose selection and optimization cohort will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. The Phase 2 subcutaneous (SC) safety cohort participants will receive 1 of 2 doses of etentamig in combination with daratumumab. Participants in phase 3 will receive RP3D doses of etentamig as IV infusions, combination with SC injections of daratumumab, or SC injections of daratumumab, capsules of lenalidomide, and tablet/ IV injections of dexamethasone (DRd). The study duration is approximately 16 years.
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.
All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:
Exclusion Criteria:
Participants will receive etentamig dose A in combination with daratumumab until the recommended phase 3 dose (RP3D), as part of the approximately 16 year study duration.
Drug: Etentamig · Drug: Daratumumab
Participants will receive etentamig dose B in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Drug: Etentamig · Drug: Daratumumab
Participants will receive etentamig dose C in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Drug: Etentamig · Drug: Daratumumab
Participants will receive subcutaneous (SC) etentamig dose A in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Drug: Daratumumab · Drug: Etentamig
Participants will receive subcutaneous (SC) etentamig dose B in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Drug: Daratumumab · Drug: Etentamig
Participants will receive etentamig at the RP3D in combination with daratumumab, as part of the approximately 16 year study duration.
Drug: Etentamig · Drug: Daratumumab
Participants will receive DRd, as part of the approximately 16 year study duration.
Drug: Lenalidomide · Drug: Daratumumab · Drug: Dexamethasone
Intravenous (IV) Infusion
Oral Capsule
Subcutaneous Injection
Oral Tablet
IV Injection
Subcutaneous Injection
Phase 2 and 3: Percentage of Participants with Adverse Events (AE)s
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.
Time frame: Up to Approximately 16 Years
Phase 2: Change in Clinical Activity
Clinical activity is defined as change in response rates \[Overall Response Rate (ORR), Complete Response (CR) or Better, Very Good Partial Response (VGPR), Partial Response (PR)\] as determined International Myeloma Working Group (IMWG (2016).
Time frame: Up to Approximately 52 weeks
Phase 3: Minimal Residual Disease (MRD) Negative CR Rate
MRDnegCR rate, is defined as the percentage of participants who have achieved stringent complete response (sCR) or CR as assessed by independent review committee (IRC) and have negative MRD defined at 10\^-5 threshold as assessed by next generation sequencing (NGS).
Time frame: Up to Approximately 52 weeks
Phase 3: Progression-Free Survival (PFS)
PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by IRC per IMWG (2016) response criteria, or death, whichever occurs first.
Time frame: Up to Approximately 130 Months
Phase 2: MRD Negative CR Rate
MRDnegCR rate, is defined as the percentage of participants who have achieved sCR or CR and have negative MRD defined at 10\^-5 threshold as assessed by NGS.
Time frame: Up to Approximately 52 Weeks
Phase 2: PFS
PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by IRC per IMWG (2016) response criteria, or death, whichever occurs first.
Time frame: Up to Approximately 130 Months
Phase 2: Sustained MRD Negativity Rate
The rate of sustained MRD-negativity is defined as the percentage of participants with maintenance of MRD negativity status in bone marrow confirmed \>=12 months apart prior to initiation of new anti-MM therapy.
Time frame: Up to Approximately 12 Months
Phase 2: Area Under the Serum Concentration-Time Curve (AUC)
Area under the plasma concentration-time curve (AUC).
Time frame: Up to Approximately 12 Months
Phase 2: Overall Survival (OS)
OS is defined as the duration from the date of randomization to the date of the participant's death.
Time frame: Up to Approximately 16 Years
Phase 2: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability
Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)
Time frame: Up to Approximately 16 Years
Phase 2: Maximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax).
Time frame: Up to Approximately 12 Months
Phase 2: Time to Cmax (Time to Maximum Observed Concentration, Tmax)
Time to Cmax.
Time frame: Up to Approximately 12 Months
Phase 2: Positive Anti-Drug Antibodies (ADAs)
Positive ADAs.
Time frame: Up to Approximately 90 days after the last dose of study treatment
Phase 2: Negative ADAs
Negative ADAs.
Time frame: Up to Approximately 90 days after the last dose of study treatment
Phase 2: Neutralizing Anti-Drug Antibodies (NAbs)
Neutralizing anti-drug antibodies (NAbs).
Time frame: Up to Approximately 90 days after the last dose of study treatment
Phase 3: OS
OS is defined as the duration from the date of randomization to the date of the participant's death.
Time frame: Up to Approximately 16 Years
Phase 3: Sustained MRD Negativity Rate
The rate of sustained MRD-negativity is defined as the percentage of participants with maintenance of MRD negativity status in bone marrow confirmed \>=12 months apart prior to initiation of new anti-MM therapy.
Time frame: Up to Approximately 12 Months
Phase 3: Rate of >= CR
The rate of \>= CR is defined as the percentage of participants who achieve a sCR or CR determined by IMWG (2016) response criteria, per IRC assessment, prior to the initiation of new anti-myeloma therapy.
Time frame: Up to Approximately 12 Months
Phase 3: Rate of >= VGPR or Better
The rate of \>= VGPR is defined as the percentage of participants who achieve a VGPR or better determined by IMWG (2016) response criteria, per IRC assessment, prior to the initiation of new anti-myeloma therapy.
Time frame: Up to Approximately 12 Months
Phase 3: ORR
ORR is defined as percentage of participants with a response of PR or better per IMWG criteria.
Time frame: Up to Approximately 52 Weeks
Phase 3: Time to Response (TTR)
TTR is defined as the number of months from the date of randomization to the date of best overall response of CR or PR ('responders') determined by IMWG criteria as assessed by investigator.
Time frame: Up to Approximately 12 Months
Phase 3: Duration of Response (DOR)
DOR is defined as the number of days from the day the response criteria are met to the date that disease progression.
Time frame: Up to Approximately 16 Years
Phase 3: Time-to-Progression (TTP)
Time to progression is defined as the number of days from the date of randomization to the date of the first documented disease progression or relapse.
Time frame: Up to Approximately 16 Years
Phase 3: Event Free Survival (EFS)
EFS will be measured as the number of days between the initiation of the subsequent anticancer therapy and disease progression, or refractory disease, or death.
Time frame: Up to Approximately 16 Years
Phase 3: Progression-Free Survival on Subsequent Therapy (PFS2)
PFS2 is defined as the duration from the date of randomization to the date of confirmed disease progression on the next line of therapy or death, whichever occurs first
Time frame: Up to Approximately 16 Years
Phase 3: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability
Incidence, severity, seriousness, and causality of TEAEs
Time frame: Up to Approximately 16 Years
Phase 3: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Score
The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Subjects rate items on a 4- point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).
Time frame: Up to Approximately 16 Years
Phase 3: Change from Baseline in EORTC QLQ-C30 Global Health Status/QoL Score
The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Subjects rate items on a 4- point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).
Time frame: Up to Approximately 16 Years
Phase 3: Change from Baseline and Time to Deterioration in the Remaining Scales and Items of EORTC QLQ-C30
The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Subjects rate items on a 4- point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).
Time frame: Up to Approximately 16 Years
Phase 3: Symptomatic AEs as Assessed by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0/1 for absent/present).
Time frame: Up to Approximately 16 Years
Phase 3: Overall Bother Due to Treatment Side Effects as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) GP5
The FACT-G GP5 Item is a part of the FACT-G which is a 27-item questionnaire that measures four domains of health-related quality of life (HRQOL) in cancer patients: physical, social, emotional and functional well-being. The FACT-G GP5 item ("I am bothered by side effects of treatment") is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on patients. This item is rated on a 5-point Likert scale from "not at all" to "very much.".
Time frame: Up to Approximately 16 Years
Phase 3: Change from Baseline in Patient Global Impression of Severity (PGIS) Scores
The PGIS scale asks the patient to assess their overall QoL, as well as difficulty of doing physical activities due to MM over the past 7 days. Each item employs a 5-point Likert scale from "not at all" to "very much."
Time frame: Up to Approximately 16 Years
Phase 3: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores
The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Time frame: Up to Approximately 16 Years
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
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