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NCT Number: NCT06892522

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Coffs Harbour Health Campus /ID# 272010, Coffs Harbour, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etentamig

Drug

Intravenous (IV) Infusion

Lenalidomide

Drug

Oral

Dexamethasone

Drug

IV Injection

Daratumumab

Drug

Subcutaneous Injection

Carfilzomib

Drug

IV Infusion

mezigdomide

Drug

Oral

Iberdomide

Drug

Oral

ABBV-2001

Drug

subcutaneous (SC) Injection

Primary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: Up to Approximately 52 Weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Mar 24, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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