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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06896916
Registration number
NCT06896916
Ethics application status
Date submitted
19/03/2025
Date registered
26/03/2025
Date last updated
9/09/2025
Titles & IDs
Public title
Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma
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Scientific title
Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
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Secondary ID [1]
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2024-512146-41-00
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Secondary ID [2]
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M24-555
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Etentamig
Treatment: Drugs - Iberdomide
Experimental: Phase 1: ABBV-383 Dose Escalation - In phase 1 participants will receive escalating Etentamig in combination with iberdomide, as part of the approximately 129 month study duration.
Experimental: Phase 2: ABBV-383 Dose Expansion Dose A - In phase 2 participants will receive Etentamig at dose A in combination with iberdomide, as part of the approximately 129 month study duration.
Experimental: Phase 2: ABBV-383 Dose Expansion Dose B - In phase 2 participants will receive Etentamig at dose B in combination with iberdomide, as part of the approximately 129 month study duration.
Treatment: Drugs: Etentamig
Intravenous (IV) Infusion
Treatment: Drugs: Iberdomide
Oral Capsule
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to Approximately 56 Days
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Primary outcome [2]
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Number of Participants with Adverse Events (AE)s
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Assessment method [2]
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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.
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Timepoint [2]
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Up to Approximately 129 Months
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Secondary outcome [1]
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Partial Response (PR) Response Rate (RR)
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Assessment method [1]
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PR is defined \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hours, if the serum and urine M-protein are unmeasurable, a \>= 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, if the serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, a \>= 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>= 30%, \>= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline.
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Timepoint [1]
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Up to 3 Years
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Secondary outcome [2]
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Very Good Partial Response (VGPR) RR
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Assessment method [2]
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VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>= 90% reduction in serum M-protein plus urine M-protein \< 100 mg per 24 hours, for participants in whom the only measurable disease is by serum free light chains (FLC) levels, VGPR is defined as \>= 90% decrease in the difference between involved and uninvolved FLC levels.
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Timepoint [2]
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Up to 3 Years
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Secondary outcome [3]
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Complete Response (CR) RR
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Assessment method [3]
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CR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in bone marrow, and for participants in whom the only measurable disease is by serum FLC levels, a normal FLC ratio is also required.
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Timepoint [3]
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Up to 3 Years
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Secondary outcome [4]
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Stringent Complete Response (sCR) RR
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Assessment method [4]
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sCR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in bone marrow, normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry (kappa/lambda ratio \<= 4:1 or \>= 1:2 for kappa and lambda participants, respectively, after counting \>= 100 plasma cells).
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Timepoint [4]
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Up to 3 Years
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Secondary outcome [5]
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Overall Response Rate (ORR)
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Assessment method [5]
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ORR (PR + VGPR + CR + sCR) will be defined as the proportion of participants who achieved a PR or better.
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Timepoint [5]
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Up to 3 Years
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Secondary outcome [6]
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Progression-Free Survival (PFS)
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Assessment method [6]
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PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.
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Timepoint [6]
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Up to 3 Years
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Secondary outcome [7]
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Duration of Response (DOR)
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Assessment method [7]
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DOR is defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first.
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Timepoint [7]
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Up to 3 Years
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Secondary outcome [8]
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Time-to-Progression (TTP)
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Assessment method [8]
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TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression.
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Timepoint [8]
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Up to 3 Years
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Secondary outcome [9]
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Minimal Residual Disease (MRD) negativity
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Assessment method [9]
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The MRD negativity rate is defined as the proportion of participants who achieve MRD negative status.
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Timepoint [9]
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Up to 3 Years
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Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance of 0 to 1.
* Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
* All participants must have measurable diseases per central laboratory as outlined in protocol
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has received prior etentamig treatment.
* Prior exposure to BCMA-targeted therapy as noted in the protocol.
* Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/08/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2036
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Actual
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Sample size
Target
135
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Blacktown Hospital /ID# 265983 - Blacktown
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Recruitment hospital [2]
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Wollongong Hospital /ID# 265625 - Wollongong
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Recruitment hospital [3]
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Austin Hospital /ID# 265984 - Melbourne
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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3084 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
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France
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State/province [2]
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Indre-et-Loire
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Country [3]
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France
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State/province [3]
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Occitanie
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Country [4]
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Japan
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State/province [4]
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Kumamoto
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Country [5]
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Japan
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State/province [5]
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Tochigi
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Country [6]
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Japan
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State/province [6]
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Tokyo
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed. Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide. In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.
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Trial website
https://clinicaltrials.gov/study/NCT06896916
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Country
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Phone
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844-663-3742
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
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Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06896916
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