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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06892522
Registration number
NCT06892522
Ethics application status
Date submitted
19/03/2025
Date registered
24/03/2025
Date last updated
11/09/2025
Titles & IDs
Public title
A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib
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Scientific title
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects With Multiple Myeloma
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Secondary ID [1]
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2024-515770-27-00
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Secondary ID [2]
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M25-059
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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 - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Daratumumab
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Carfilzomib
Experimental: Substudy 1: Etentamig Dose Escalation - Participants will receive escalating etentamig in combination with daratumumab, and lenalidomide (DR), as part of the approximately 130 month study duration.
Experimental: Substudy 1: Etentamig Dose Expansion Dose Level 1 - Participants will receive dose level 1 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Experimental: Substudy 1: Etentamig Dose Expansion Dose Level 2 - Participants will receive dose level 2 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Experimental: Substudy 1: Comparator - Participants will receive daratumumab, lenalidomide, and dexamethasone (DRd), as part of the approximately 130 month study duration.
Experimental: Substudy 2: Etentamig Dose Escalation - Participants will receive escalating etentamig, as part of the approximately 130 month study duration.
Experimental: Substudy 2: Etentamig Dose Expansion Dose Level 1 - Participants will receive dose level 1 of etentamig, as part of the approximately 130 month study duration.
Experimental: Substudy 2: Etentamig Dose Expansion Dose Level 2 - Participants will receive dose level 2 of etentamig, as part of the approximately 130 month study duration.
Experimental: Substudy 2: Comparator - Participants will receive lenalidomide (R), as part of the approximately 130 month study duration.
Experimental: Substudy 3: Etentamig Dose Escalation - Participants will receive escalating etentamig in combination with carfilzomib, and dexamethasone (Kd), as part of the approximately 130 month study duration.
Experimental: Substudy 3: Etentamig Dose Expansion Dose Level 1 - Participants will receive dose level 1 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Experimental: Substudy 3: Etentamig Dose Expansion Dose Level 2 - Participants will receive dose level 2 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Experimental: Substudy 3: Comparator - Participants will receive daratumumab, carfilzomib, and dexamethasone (DKd), as part of the approximately 130 month study duration.
Experimental: Substudy 4: Etentamig Dose Escalation - Participants will receive escalating etentamig in combination with R, as part of the approximately 130 month study duration.
Experimental: Substudy 4: Etentamig Dose Expansion Dose Level 1 - Participants will receive dose level 1 of etentamig in combination with R, as part of the approximately 130 month study duration.
Experimental: Substudy 4: Etentamig Dose Expansion Dose Level 2 - Participants will receive dose level 2 of etentamig in combination with R, as part of the approximately 130 month study duration.
Treatment: Drugs: Etentamig
Intravenous (IV) Infusion
Treatment: Drugs: Lenalidomide
Oral Capsule
Treatment: Drugs: Dexamethasone
IV Injection
Treatment: Drugs: Daratumumab
Subcutaneous Injection
Treatment: Drugs: Dexamethasone
Oral Tablet
Treatment: Drugs: Carfilzomib
IV Infusion
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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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Number of Participants with Adverse Events (AE)s
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Assessment method [1]
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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 [1]
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Up to Approximately 130 Months
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Primary outcome [2]
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Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)
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Assessment method [2]
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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 [2]
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Up to Approximately 8 weeks
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Primary outcome [3]
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Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM)
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Assessment method [3]
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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 [3]
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Up to Approximately 8 Weeks
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Primary outcome [4]
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Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM)
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Assessment method [4]
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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 [4]
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Up to Approximately 8 Weeks
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Primary outcome [5]
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Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM
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Assessment method [5]
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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 [5]
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Up to Approximately 8 Weeks
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Secondary outcome [1]
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Substudy 1, 2, 3, 4: Complete Response Rate
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Assessment method [1]
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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.
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Timepoint [1]
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Up to Approximately 1 Year
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Secondary outcome [2]
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Substudy 1, 2, 3, 4: Overall Response Rate (ORR)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to Approximately 1 Year
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Secondary outcome [3]
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Substudy 1, 2, 3, 4: Progression Free Survival (PFS)
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Assessment method [3]
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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 (determined by the IMWG) or death.
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Timepoint [3]
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Up to Approximately 130 Months
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Secondary outcome [4]
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Substudy 1, 2, 3, 4: Duration of Response (DOR)
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Assessment method [4]
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DOR is defined as the time from the date of first response to the earliest occurrence of progressive disease, or death, whatever occurs first.
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Timepoint [4]
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Up to Approximately 130 Months
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Secondary outcome [5]
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Substudy 1, 2, 3, 4: Time-to-Progression (TTP)
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Assessment method [5]
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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 [5]
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Up to Approximately 130 Months
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Secondary outcome [6]
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Substudy 1, 2, 3, 4: Minimal Residual Disease (MRD) negativity
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Assessment method [6]
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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 [6]
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Up to Approximately 52 Weeks
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Eligibility
Key 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.
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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
* Participant who has known active central nervous system involvement of MM.
* Participant who has known active infection as outlined in the protocol.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Parallel
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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
30/06/2025
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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
440
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Coffs Harbour Health Campus /ID# 272010 - Coffs Harbour
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Recruitment hospital [2]
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Port Macquarie Base Hospital /ID# 275925 - Port Macquarie
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Recruitment hospital [3]
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Icon Cancer Care - South Brisbane /ID# 271836 - South Brisbane
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Recruitment hospital [4]
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Royal Adelaide Hospital /ID# 272629 - Adelaide
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Recruitment hospital [5]
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Peter MacCallum Cancer Centre /ID# 272024 - Melbourne
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Recruitment hospital [6]
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The Perth Blood Institute - West Perth /ID# 272469 - West Perth
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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Recruitment postcode(s) [2]
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2444 - Port Macquarie
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3000 - Melbourne
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Recruitment postcode(s) [6]
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6005 - West Perth
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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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United States of America
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State/province [2]
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North Carolina
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Country [3]
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Israel
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State/province [3]
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Tel Aviv
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Country [4]
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Israel
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State/province [4]
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Haifa
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Country [5]
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Israel
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State/province [5]
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Jerusalem
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Country [6]
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Israel
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State/province [6]
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Petah Tikva
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Country [7]
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Japan
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State/province [7]
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Kyoto
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Country [8]
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Japan
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State/province [8]
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Osaka
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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 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 in adult participants with MM. Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. 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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Trial website
https://clinicaltrials.gov/study/NCT06892522
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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/NCT06892522
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