Etentamig (ABBV-383) alone or with daratumumab, lenalidomide, dexamethasone, or carfilzomib for adults with multiple myeloma.
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects With Multiple Myeloma
PHASE1; PHASE2 · AbbVie · NCT06892522
This will test whether etentamig (ABBV-383), given by IV alone or with daratumumab, lenalidomide, dexamethasone, or carfilzomib, is safe and helps adults with multiple myeloma, including relapsed or refractory disease.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie (industry) |
| Drugs / interventions | daratumumab |
| Locations | 25 sites (Denver, Colorado and 24 other locations) |
| Trial ID | NCT06892522 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 program enrolls adults with multiple myeloma into four parallel substudies, each with a dose-escalation phase followed by a dose-expansion phase. Participants receive escalating intravenous doses of etentamig alone or combined with daratumumab plus lenalidomide (DR), carfilzomib plus dexamethasone (Kd), or lenalidomide (R), and then continue at the doses defined in escalation. The trial collects safety and adverse event data, measures changes in disease activity, and characterizes pharmacokinetics. Treatments and follow-up visits occur at participating cancer centers to monitor response and side effects.
Who should consider this trial
Good fit: Adults with confirmed multiple myeloma and good performance status (ECOG ≤ 1) who meet the substudy-specific criteria for newly diagnosed or relapsed/refractory disease are the intended participants.
Not a fit: Patients with known active central nervous system involvement of myeloma, active infections as defined in the protocol, or who do not meet performance/prior-treatment criteria are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, etentamig alone or in combination could provide a new treatment option that helps control disease and extend remission for adults with relapsed, refractory, or certain newly diagnosed multiple myeloma.
How similar studies have performed: Other BCMA-targeted agents and combination regimens have shown promising activity in multiple myeloma, but etentamig and these specific combinations remain investigational and are being tested in early-phase trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Denver, Colorado and 24 other locations
- Colorado Blood Cancer Institute /ID# 273129 — Denver, Colorado, United States (RECRUITING)
- Moffitt Cancer Center /ID# 272628 — Tampa, Florida, United States (RECRUITING)
- Winship Cancer Institute of Emory University /ID# 274830 — Atlanta, Georgia, United States (RECRUITING)
- Weill Cornell Medical College /ID# 272517 — New York, New York, United States (RECRUITING)
- University of North Carolina at Chapel Hill /ID# 274667 — Chapel Hill, North Carolina, United States (RECRUITING)
- Atrium Health Levine Cancer Institute /ID# 276193 — Charlotte, North Carolina, United States (RECRUITING)
- Atrium Health Wake Forest Baptist Medical Center /ID# 274847 — Winston-Salem, North Carolina, United States (RECRUITING)
- Oncology Hematology Care - Kenwood /ID# 272918 — Cincinnati, Ohio, United States (RECRUITING)
- Coffs Harbour Health Campus /ID# 272010 — Coffs Harbour, New South Wales, Australia (RECRUITING)
- Port Macquarie Base Hospital /ID# 275925 — Port Macquarie, New South Wales, Australia (RECRUITING)
- Westmead Hospital /ID# 271880 — Westmead, New South Wales, Australia (RECRUITING)
- Icon Cancer Care - South Brisbane /ID# 271836 — South Brisbane, Queensland, Australia (RECRUITING)
- Royal Adelaide Hospital /ID# 272629 — Adelaide, South Australia, Australia (RECRUITING)
- St Vincent's Hospital - Melbourne /ID# 276451 — Fitzroy, Victoria, Australia (RECRUITING)
- Peter MacCallum Cancer Centre /ID# 272024 — Melbourne, Victoria, Australia (RECRUITING)
- The Perth Blood Institute - West Perth /ID# 272469 — West Perth, Western Australia, Australia (RECRUITING)
- Soroka Medical Center /ID# 271367 — Beersheba, Southern District, Israel (RECRUITING)
- The Chaim Sheba Medical Center /ID# 271366 — Ramat Gan, Tel Aviv, Israel (RECRUITING)
- Rambam Health Care Campus- Haifa /ID# 271364 — Haifa, Israel (RECRUITING)
- Hadassah Medical Center-Hebrew University /ID# 271362 — Jerusalem, Israel (RECRUITING)
- Rabin Medical Center. /ID# 271365 — Petah Tikva, Israel (RECRUITING)
- Nagoya City University Hospital /ID# 273529 — Nagoya, Aichi-ken, Japan (RECRUITING)
- University Hospital Kyoto Prefectural University of Medicine /ID# 275713 — Kyoto, Kyoto, Japan (RECRUITING)
- The University of Osaka Hospital /ID# 275791 — Suita-shi, Osaka, Japan (RECRUITING)
- Hammersmith Hospital /ID# 274615 — London, England, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: ABBVIE CALL CENTER
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma, Multiple Myeloma, Etentamig, ABBV-383, Cancer, Daratumumab, Lenalidomide, Dexamethasone, Carfilzomib