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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

36 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Multiple Myeloma

Being tested

Etentamig, Lenalidomide, Dexamethasone, Daratumumab, Carfilzomib

Keywords

Multiple Myeloma, Etentamig, ABBV-383, Cancer, Daratumumab, Lenalidomide, Dexamethasone, Carfilzomib, ABBV-2001, Iberdomide, Mezigdomide, Pomalidomide

Medical subject headings

Multiple Myeloma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• EtentamigDrug

  Intravenous (IV) Infusion

• LenalidomideDrug

  Oral

• DexamethasoneDrug

  IV Injection

• DaratumumabDrug

  Subcutaneous (SC) Injection

• DexamethasoneDrug

  Oral

• CarfilzomibDrug

  Intravenous (IV) Infusion

• MezigdomideDrug

  Oral

• IberdomideDrug

  Oral

• ABBV-2001Drug

  Subcutaneous (SC) Injection

• EtentamigDrug

  Subcutaneous (SC) Injection

• PomalidomideDrug

  Oral

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   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.

   Measured: Up to Approximately 130 Months

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

   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.

   Measured: Up to Approximately 8 weeks

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

   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.

   Measured: Up to Approximately 8 Weeks

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

   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.

   Measured: Up to Approximately 8 Weeks

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

   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.

   Measured: Up to Approximately 8 Weeks

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

   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.

   Measured: Up to Approximately 8 Weeks

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

   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.

   Measured: Up to Approximately 8 Weeks

8. Substudy 7: DLT of ABBV-2001 in Combination with Pomalidomide in Participants with RR MM

   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.

   Measured: Up to Approximately 8 Weeks

9. Substudy 8: DLT of ABBV-2001 in Combination with Lenalidomide in Participants with RR MM

   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.

   Measured: Up to Approximately 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted24 Mar 2025
2. Study start30 Jun 2025
3. Primary completionDec 2035 (estimated)
4. Study completionMar 2036 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Multiple MyelomaStudies of the same condition, open and under way.
• More trials run by AbbVieThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.