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
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
602
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Lead sponsor
AbbVie
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Start date
2025-06-30
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Number of sites
34
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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 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.
clinicaltrials.gov
Short title
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
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2035-12-01
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First posted
2025-03-24
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Registry last updated
2026-07-21
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Primary completion date
2035-12-01
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Start date
2025-06-30
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Participants
602
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Participant count basis
Estimated
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Planned participants
602
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Protocol amendments
2
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Number of sites
34
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AbbVie
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06892522
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ClinicalTrials.gov ID
NCT06892522
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Participants with Adverse Events (AE)s

    Timeframe: Up to Approximately 130 Months

    An adverse event 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.

  2. Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)

    Timeframe: Up to Approximately 8 weeks

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

  3. Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM)

    Timeframe: Up to Approximately 8 Weeks

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

  4. Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM)

    Timeframe: Up to Approximately 8 Weeks

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

  5. Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM

    Timeframe: Up to Approximately 8 Weeks

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

  6. Substudy 5: DLT of ABBV-2001 in Combination with Iberdomide in Participants with RR MM

    Timeframe: Up to Approximately 8 Weeks

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

  7. Substudy 6: DLT of ABBV-2001 in Combination with Mezigdomide in Participants with RR MM

    Timeframe: Up to Approximately 8 Weeks

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

  1. Substudy 1, 2, 3, 4, 5, 6: Complete Response Rate

    Timeframe: Up to Approximately 1 Year

    Complete response rate is defined as complete response (CR), stringent complete response (sCR) as assessed by the international myeloma working group (IMWG) 2016 criteria for MM.

  2. Substudy 1, 2, 3, 4, 5, 6: Overall Response Rate (ORR)

    Timeframe: Up to Approximately 1 Year

    The ORR is defined as the percentage of participants who achieve a best overall response of confirmed PR or better determined by IMWG criteria, prior to the initiation of subsequent myeloma therapy.

  3. Substudy 1, 2, 3, 4, 5, 6: Progression Free Survival (PFS)

    Timeframe: Up to Approximately 130 Months

    PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IMWG) or death.

  4. Substudy 1, 2, 3, 4, 5, 6: Duration of Response (DOR)

    Timeframe: Up to Approximately 130 Months

    DOR is defined as the time from the date of first response to the earliest occurrence of progressive disease, or death, whatever occurs first.

  5. Substudy 1, 2, 3, 4, 5, 6: Time-to-Progression (TTP)

    Timeframe: Up to Approximately 130 Months

    TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression.

  6. Substudy 1, 2, 3, 4, 5, 6: Minimal Residual Disease (MRD) negativity

    Timeframe: Up to Approximately 52 Weeks

    The MRD negativity rate is defined as the proportion of participants who achieve MRD negative status.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • Participant who has known active central nervous system involvement of MM.
  • Participant who has known active infection as outlined in the protocol.
Sources for eligibility
clinicaltrials.gov

  • City of Hope National Medical Center /ID# 273132Duarte, United StatesRecruiting
  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277911Irvine, United StatesRecruiting
  • Colorado Blood Cancer Institute /ID# 273129Denver, United StatesRecruiting
  • Moffitt Cancer Center /ID# 272628Tampa, United StatesRecruiting
  • Winship Cancer Institute of Emory University /ID# 274830Atlanta, United StatesRecruiting
  • Mount Sinai - The Tisch Cancer Institute /ID# 272470New York, United StatesRecruiting
  • Weill Cornell Medical College /ID# 272517New York, United StatesRecruiting
  • University of North Carolina at Chapel Hill /ID# 274667Chapel Hill, United StatesRecruiting
  • Atrium Health Levine Cancer Institute /ID# 276193Charlotte, United StatesRecruiting
  • Atrium Health Wake Forest Baptist Medical Center /ID# 274847Winston-Salem, United StatesRecruiting
  • Oncology Hematology Care - Blue Ash /ID# 272918Cincinnati, United StatesRecruiting
  • The Ohio State University /ID# 271336Columbus, United StatesRecruiting
  • University of Texas - Southwestern Medical Center /ID# 274360Dallas, United StatesRecruiting
  • Huntsman Cancer Institute /ID# 272575Salt Lake City, United StatesRecruiting
  • Coffs Harbour Health Campus /ID# 272010Coffs Harbour, AustraliaRecruiting
  • Port Macquarie Base Hospital /ID# 275925Port Macquarie, AustraliaRecruiting
  • Westmead Hospital /ID# 271880Westmead, AustraliaRecruiting
  • Icon Cancer Care - South Brisbane /ID# 271836South Brisbane, AustraliaRecruiting
  • Royal Adelaide Hospital /ID# 272629Adelaide, AustraliaRecruiting
  • St Vincent's Hospital - Melbourne /ID# 276451Fitzroy, AustraliaRecruiting
  • Peter MacCallum Cancer Centre. /ID# 272024Melbourne, AustraliaRecruiting
  • The Perth Blood Institute - West Perth /ID# 272469West Perth, AustraliaRecruiting
  • Rabin Medical Center. /ID# 271365Petah Tikva, IsraelRecruiting
  • Soroka Medical Center /ID# 271367Beersheba, IsraelRecruiting
  • The Chaim Sheba Medical Center /ID# 271366Ramat Gan, IsraelRecruiting

And 9 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-515770-27-00
Sources for references
clinicaltrials.gov

Related records

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