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
a study on Multiple Myeloma Neoplasms
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedstudy ends around
Description
Summary
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 8 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 and R. Participants in substudies 5-8 will receive up to two doses of ABBV-2001 or at the dose level(s) established during the escalation phases of ABBV-2001 with iberdomide, mezigdomide, pomalidomide or lenalidomide. Around 602 adult participants with MM will be enrolled at approximately 55 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 SC injections of etentamig at the dose levels established during the escalation phases alone or with DR or K. In substudy 4, participants will receive escalating doses of etentamig as Intravenous (IV) infusions followed by SC injections of etentamig at the dose levels established during the escalation phase with Lenalidomide. In substudies 5-8, participants will receive up to two doses of ABBV-2001 as subcutaneous (SC) injections, with oral iberdomide, mezigdomide, pomalidomide or lenalidomide followed by SC injections of ABBV-2001 at the dose level(s) established during the escalation phases with oral iberdomide, mezigdomide, pomalidomide or lenalidomide. 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.
Official Title
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
Keywords
Multiple Myeloma, Multiple Myeloma, Etentamig, ABBV-383, Cancer, Daratumumab, Lenalidomide, Dexamethasone, Carfilzomib, ABBV-2001, Iberdomide, Mezigdomide, Pomalidomide, Neoplasms, Etentamig
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- Participant who has known active central nervous system involvement of MM.
- Participant who has known active infection as outlined in the protocol.
Locations
- University Of California, San Francisco /ID# 271662
accepting new patients
San Francisco California 94143-2202 United States - City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277911
accepting new patients
Irvine California 92618 United States - City of Hope National Medical Center /ID# 273132
accepting new patients
Duarte California 91010 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- AbbVie
- ID
- NCT06892522
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 602 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Providing your contact details does not obligate you to participate in the research.
Thank you!
The study team should get back to you in a few business days.