A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-specific Antibodies Intravenously (IV)/Subcutaneously (SC) Alone or in Combinations (NCT06892522)
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of T Cell Engaging Bi/Tri-specific Antibodies in Subjects With MM
๐ฉบ Plain-English Summary (8th-Grade Level)
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 and ABBV-2001 in adult participants with MM. Etentamig and ABBV-2001 are investigational drugs being developed for the treatment of MM. This study is broken into 6 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants in substudies 1-4 will receive escalating doses of etentamig alone or with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R), followed by etentamig at the dose levels established during the escalation phases alone or with DR, Kd, R. Participants in substudies 1-4 can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Participants in substudies 5-6 will receive escalating doses or at the dose levels established during the escalation phases of ABBV-2001 with iberdomide or mezigdomide. Around 602 adult participants with MM will be enrolled at approximately 75 sites worldwide In substudies 1-3, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or with IV and DRd, DKd, or R. In substudie 4, participants will receive escalating doses of etentamig as Intravenous (IV) infusions followed by IV infusions of etentamig at the dose levels established during the escalation phase. In substudies 5-6, participants will receive escalating doses of ABBV-2001 as subcutaneous (SC) injections, with oral iberdomide or mezigdomide, followed by SC injections of ABBV-2001 at the dose levels established during the escalation phases with oral iberdomide or mezigdomide. 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.
Who can join: Review the eligibility criteria below.
Location: City of Hope National Medical Center /ID# 273132 โ Duarte, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (34 Sites)
Showing the first 25 of 34 sites.
- City of Hope National Medical Center /ID# 273132 โ Duarte, California
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277911 โ Irvine, California
- Colorado Blood Cancer Institute /ID# 273129 โ Denver, Colorado
- Moffitt Cancer Center /ID# 272628 โ Tampa, Florida
- Winship Cancer Institute of Emory University /ID# 274830 โ Atlanta, Georgia
- Mount Sinai - The Tisch Cancer Institute /ID# 272470 โ New York, New York
- Weill Cornell Medical College /ID# 272517 โ New York, New York
- University of North Carolina at Chapel Hill /ID# 274667 โ Chapel Hill, North Carolina
- Atrium Health Levine Cancer Institute /ID# 276193 โ Charlotte, North Carolina
- Atrium Health Wake Forest Baptist Medical Center /ID# 274847 โ Winston-Salem, North Carolina
- Oncology Hematology Care - Blue Ash /ID# 272918 โ Cincinnati, Ohio
- The Ohio State University /ID# 271336 โ Columbus, Ohio
- University of Texas - Southwestern Medical Center /ID# 274360 โ Dallas, Texas
- Huntsman Cancer Institute /ID# 272575 โ Salt Lake City, Utah
- Coffs Harbour Health Campus /ID# 272010 โ Coffs Harbour, New South Wales
- Port Macquarie Base Hospital /ID# 275925 โ Port Macquarie, New South Wales
- Westmead Hospital /ID# 271880 โ Westmead, New South Wales
- Icon Cancer Care - South Brisbane /ID# 271836 โ South Brisbane, Queensland
- Royal Adelaide Hospital /ID# 272629 โ Adelaide, South Australia
- St Vincent's Hospital - Melbourne /ID# 276451 โ Fitzroy, Victoria
- Peter MacCallum Cancer Centre. /ID# 272024 โ Melbourne, Victoria
- The Perth Blood Institute - West Perth /ID# 272469 โ West Perth, Western Australia
- Rabin Medical Center. /ID# 271365 โ Petah Tikva, Central District
- Soroka Medical Center /ID# 271367 โ Beersheba, Southern District
- The Chaim Sheba Medical Center /ID# 271366 โ Ramat Gan, Tel Aviv
๐ Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Multiple Myeloma
- Ixazomib + Pomalidomide + Dexamethasone In MM โ Boston, Massachusetts
- A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma โ Birmingham, Alabama
- Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant โ Tampa, Florida
- MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb โ Beverly Hills, California
- A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma โ Phoenix, Arizona
- A Study of Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma โ Hackensack, New Jersey
Explore by condition: All Multiple Myeloma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.