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 2026-10-19.
Sponsored by AbbVie · Phase 2/3, Interventional, and Treatment
Among 10 studies testing etentamig in Multiple Myeloma — 6 open to participants now, 10 under way, 3 of them phase 3. etentamig · Multiple Myeloma.
Among the 10 studies testing etentamig in Multiple Myeloma, this one has the largest planned enrollment, is one of 3 that started in 2026, is the only one in phase 2/3, and was the 8th registered.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
Browse Multiple Myeloma studies →6 of the 10 studies testing etentamig in Multiple Myeloma are open now, in 12 countries. Recruiting first, the newest first:
AbbVie · Sites in United States, Australia, Canada and 4 more countries
AbbVie · Sites in United States, Australia, Israel and 3 more countries
AbbVie · Sites in United States, Canada, Denmark and 4 more countries
Universitätsklinikum Hamburg-Eppendorf · Sites in Germany
AbbVie · Sites in United States, Australia, Canada and 10 more countries
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 584 Multiple Myeloma studies recruiting now, 429 (73%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 4 · Phase 3 3
First in 2019; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 680 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Median enrollment 235 across the 10 interventional studies. None of them has completed or been terminated yet.
This tab as a report to print or save as PDF → With an account.
9 of 10 have an industry lead sponsor. The 2 most frequent:
AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
30 studies in Multiple Myeloma by AbbVie: 7 open now, 17 under way, 5 of them phase 3. Of 11 finished, 3 (27%) have results posted.
Among the 30 studies in Multiple Myeloma by AbbVie, this one has the largest planned enrollment of the 29 interventional ones that give a count, is one of 3 that started in 2026, is the only one in phase 2/3, reaches primary completion later than 16 of the 16 other live ones, and was the 28th registered.
AbbVie’s Multiple Myeloma studies by the year they started, since 2012.
1 of the studies testing etentamig in Multiple Myeloma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06223516AbbVieStudy of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma | 2027-02 |
Among the 10 studies testing etentamig in Multiple Myeloma, from their registry updates:
Among AbbVie’s 30 in Multiple Myeloma:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All participants must have per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Mar 2041, 182 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 19, 2026: primary completion Sep 2040 → Mar 2041 and completion May 2041 → Jan 2042.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Etentamig · Lenalidomide · Dexamethasone