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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06158841




Registration number
NCT06158841
Ethics application status
Date submitted
28/11/2023
Date registered
6/12/2023
Date last updated
29/08/2024

Titles & IDs
Public title
Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
Scientific title
A Phase 3, Multicenter, Randomized, Open Label Study of ABBV-383 Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)
Secondary ID [1] 0 0
2023-506668-15-00
Secondary ID [2] 0 0
M22-574
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-383
Treatment: Drugs - Carfilzomib
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Selinexor
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone

Experimental: ABBV-383 - Participants will receive ABBV-383 as a monotherapy.

Experimental: Standard Available Therapy (SAT) - Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).


Treatment: Drugs: ABBV-383
Intravenous (IV) Infusion

Treatment: Drugs: Carfilzomib
IV Infusion

Treatment: Drugs: Pomalidomide
Oral Capsule

Treatment: Drugs: Elotuzumab
IV Infusion

Treatment: Drugs: Selinexor
Oral Tablet

Treatment: Drugs: Bortezomib
Subcutaneous or IV Injection

Treatment: Drugs: Dexamethasone
Oral Tablet or IV Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to Approximately 5 Years
Primary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to Approximately 5 Years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to Approximately 5 Years
Secondary outcome [2] 0 0
Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR)
Timepoint [2] 0 0
Up to Approximately 5 Years
Secondary outcome [3] 0 0
Change in Rate of CR or Better (>=CR)
Timepoint [3] 0 0
Up to Approximately 5 Years
Secondary outcome [4] 0 0
Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR
Timepoint [4] 0 0
Up to Approximately 5 Years
Secondary outcome [5] 0 0
Change from Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20)
Timepoint [5] 0 0
Up to 6 Months
Secondary outcome [6] 0 0
Change from Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
Timepoint [6] 0 0
Up to 6 Months
Secondary outcome [7] 0 0
Time to Response (TTR)
Timepoint [7] 0 0
Up to Approximately 5 Years
Secondary outcome [8] 0 0
Duration of Response (DOR)
Timepoint [8] 0 0
Up to Approximately 5 Years
Secondary outcome [9] 0 0
Time-to-Progression (TTP)
Timepoint [9] 0 0
Up to Approximately 5 Years
Secondary outcome [10] 0 0
Time to Next Anti-lymphoma Therapy (TTNT)
Timepoint [10] 0 0
Up to Approximately 5 Years
Secondary outcome [11] 0 0
Number of Participants with Event-free Survival (EFS)
Timepoint [11] 0 0
Up to Approximately 5 Years
Secondary outcome [12] 0 0
Change from Baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a)
Timepoint [12] 0 0
Up to Approximately 6 Months
Secondary outcome [13] 0 0
Change from Baseline in Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Timepoint [13] 0 0
Up to Approximately 6 Months
Secondary outcome [14] 0 0
Change from Baseline in Remaining Items in the EORTC QLQ-C30
Timepoint [14] 0 0
Up to Approximately 6 Months
Secondary outcome [15] 0 0
Change from Baseline in Remaining Items in the EORTC QLQ-MY20
Timepoint [15] 0 0
Up to Approximately 6 Months
Secondary outcome [16] 0 0
Change from Baseline in European Quality-of-Life 5-dimensional-5-level (EQ-5D-5L)
Timepoint [16] 0 0
Up to Approximately 6 Months
Secondary outcome [17] 0 0
Change from Baseline in Patient Global Impression of Severity (PGIS)
Timepoint [17] 0 0
Up to Approximately 6 Months
Secondary outcome [18] 0 0
Change from Baseline in Patient Global Impression of Change (PGIC)
Timepoint [18] 0 0
Up to Approximately 6 Months
Secondary outcome [19] 0 0
Number of Participants with Skeletal-Related Event (SRE)
Timepoint [19] 0 0
Up to Approximately 5 Years

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
* Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
* Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:

* Serum M-protein >= 0.5 g/dL (>= 5 g/L).
* Urine M-protein >= 200 mg/24 hours.
* In participants without measurable serum or urine M protein, serum free light chain (FLC) >= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
* Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
* Must be naïve to treatment with B-cell maturation antigen (BCMA)-targeted therapy.
* Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
* Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
* Central nervous system involvement of MM.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/01/2028
Actual
Sample size
Target
380
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St George Hospital /ID# 261806 - Kogarah
Recruitment hospital [2] 0 0
Calvary Mater Newcastle /ID# 261804 - Waratah
Recruitment hospital [3] 0 0
St Vincent's Hospital Melbourne /ID# 261808 - Fitzroy Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Austria
State/province [4] 0 0
Oberoesterreich
Country [5] 0 0
Austria
State/province [5] 0 0
Steiermark
Country [6] 0 0
China
State/province [6] 0 0
Beijing
Country [7] 0 0
France
State/province [7] 0 0
Sarthe
Country [8] 0 0
France
State/province [8] 0 0
Vaucluse
Country [9] 0 0
France
State/province [9] 0 0
Orléans
Country [10] 0 0
Greece
State/province [10] 0 0
Attiki
Country [11] 0 0
Greece
State/province [11] 0 0
Athens
Country [12] 0 0
Greece
State/province [12] 0 0
Thessaloniki
Country [13] 0 0
Israel
State/province [13] 0 0
Tel-Aviv
Country [14] 0 0
Israel
State/province [14] 0 0
Yerushalayim
Country [15] 0 0
Israel
State/province [15] 0 0
Haifa
Country [16] 0 0
Japan
State/province [16] 0 0
Chiba
Country [17] 0 0
Japan
State/province [17] 0 0
Gifu
Country [18] 0 0
Japan
State/province [18] 0 0
Hiroshima
Country [19] 0 0
Japan
State/province [19] 0 0
Miyagi
Country [20] 0 0
Japan
State/province [20] 0 0
Osaka
Country [21] 0 0
Japan
State/province [21] 0 0
Amagasaki
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul Teugbyeolsi
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Ulsan Gwang Yeogsi
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
Portugal
State/province [25] 0 0
Regiao Autonoma Da Madeira
Country [26] 0 0
South Africa
State/province [26] 0 0
Gauteng
Country [27] 0 0
South Africa
State/province [27] 0 0
Western Cape
Country [28] 0 0
Spain
State/province [28] 0 0
Ourense
Country [29] 0 0
Spain
State/province [29] 0 0
Leon
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Salamanca
Country [32] 0 0
Spain
State/province [32] 0 0
Valencia
Country [33] 0 0
Sweden
State/province [33] 0 0
Falun
Country [34] 0 0
Taiwan
State/province [34] 0 0
Keelung
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taipei
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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 change in disease symptoms of ABBV-383 compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM.

ABBV-383 is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. . In Arm A, participants will receive ABBV-383 as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world.

In Arm A participants will receive ABBV-383 as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
Trial website
https://clinicaltrials.gov/study/NCT06158841
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06158841