Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
- Conditions
- Interventions
- Registration Number
- NCT06158841
- Lead Sponsor
- AbbVie
- 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...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 380
-
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).
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Must be naïve to treatment with B-cell maturation antigen (BCMA)-targeted therapy.
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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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABBV-383 ABBV-383 Participants will receive ABBV-383 as a monotherapy. Standard Available Therapy (SAT) Selinexor 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). Standard Available Therapy (SAT) Bortezomib 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). Standard Available Therapy (SAT) Pomalidomide 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). Standard Available Therapy (SAT) Carfilzomib 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). Standard Available Therapy (SAT) Elotuzumab 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). Standard Available Therapy (SAT) Dexamethasone 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).
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to Approximately 5 Years ORR is defined as the percentage of participants who achieve confirmed partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR) or per IRC assessment.
Progression Free Survival (PFS) Up to Approximately 5 Years PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by independent review committee (IRC) per international myeloma working group (IMWG) (2016) response criteria, or death, whichever occurs first.
- Secondary Outcome Measures
Name Time Method 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) Up to 6 Months The physical functioning domain of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indicating worse functioning.
Change from Baseline in Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Up to Approximately 6 Months The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items are scored from 0 to 4 to evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence.
Change from Baseline in Remaining Items in the EORTC QLQ-MY20 Up to Approximately 6 Months The EORTC QLQ-MY20 consists of four scales: two symptom scales (Disease Symptoms \[6 items\] and Side Effects of Treatment \[10 items\]), one function scale (Future Perspective \[3 items\]), and one single item (Body Image). Each item has four response options: "Not at all," "A little," "Quite a bit," or "Very much". All scores are then linearly transformed ...
Change from Baseline in Patient Global Impression of Change (PGIC) Up to Approximately 6 Months The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Overall Survival (OS) Up to Approximately 5 Years OS is defined as the duration from the date of randomization to the date of the participant's death.
Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR Up to Approximately 5 Years MRD negativity with \>= CR, defined as achievement of CR or better by IMWG (2016) response criteria (per IRC assessment) and MRD negative status as assessed by next-generation sequencing (NGS) Adaptive Clonoseq at 10\^-5 threshold.
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) Up to 6 Months The disease symptoms domain of EORTC QLQ-MY20 is a 6-item questionnaire to assess the physical function of the participant, with a higher score indicating a higher level of symptoms.
Time to Next Anti-lymphoma Therapy (TTNT) Up to Approximately 5 Years TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.
Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR) Up to Approximately 5 Years The rate of \>= VGPR is defined as the proportion of participants who achieve a VGPR or better determined by IMWG (2016) response criteria, per IRC assessment, prior to the initiation of new myeloma therapy.
Change in Rate of CR or Better (>=CR) Up to Approximately 5 Years \>=CR is defined as the percentage of participants who achieve confirmed CR + sCR or per IRC assessment.
Time to Response (TTR) Up to Approximately 5 Years TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria as assessed by IRC.
Time-to-Progression (TTP) Up to Approximately 5 Years TTP is defined as the number of days from the date of first dose to the date of earliest disease progression as determined by the IRC.
Change from Baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a) Up to Approximately 6 Months The PROMIS Fatigue SF7a is a 7-item short form that assesses the impact and experience of fatigue in the past 7 days. For each item, 5-point rating scales are used to measure frequency ("Never," "Rarely," "Sometimes," "Often," or "Always") with a higher score indicating a greater impact.
Change from Baseline in Patient Global Impression of Severity (PGIS) Up to Approximately 6 Months The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity.
Duration of Response (DOR) Up to Approximately 5 Years DOR is defined as the number of days from the day the response criteria are met to the date that disease progression as determined by the IRC.
Number of Participants with Event-free Survival (EFS) Up to Approximately 5 Years EFS is defined as the time from randomization until adverse event determined by the IRC, or death, whichever occurs first.
Change from Baseline in Remaining Items in the EORTC QLQ-C30 Up to Approximately 6 Months The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessi...
Number of Participants with Skeletal-Related Event (SRE) Up to Approximately 5 Years SREs are defined as the presence of any of the following spinal cord compression, pathologic fracture, surgery to bone, or radiation to bone.
Change from Baseline in European Quality-of-Life 5-dimensional-5-level (EQ-5D-5L) Up to Approximately 6 Months The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/ depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme proble...
Trial Locations
- Locations (83)
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260883
🇨🇳Hangzhou, Zhejiang, China
Alta Bates Summit Medical Center for Research /ID# 261438
🇺🇸Berkeley, California, United States
Providence - St. Jude Medical Center /ID# 262031
🇺🇸Fullerton, California, United States
Cancer Specialists of North Florida /ID# 246230
🇺🇸Jacksonville, Florida, United States
University of Illinois at Chicago /ID# 246349
🇺🇸Chicago, Illinois, United States
Springfield Clinic /ID# 262266
🇺🇸Springfield, Illinois, United States
Center for Cancer and Blood Disorders /ID# 263637
🇺🇸Bethesda, Maryland, United States
New York Cancer & Blood Specialists - Bay Shore /ID# 261524
🇺🇸Bay Shore, New York, United States
Eastchester Center for Cancer Care /ID# 262952
🇺🇸Bronx, New York, United States
New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953
🇺🇸New Hyde Park, New York, United States
New York Cancer and Blood Specialists - New York /ID# 262951
🇺🇸New York, New York, United States
Virginia Cancer Specialists - Fairfax /ID# 262792
🇺🇸Fairfax, Virginia, United States
St George Hospital /ID# 261806
🇦🇺Kogarah, New South Wales, Australia
Liverpool Hospital /ID# 262159
🇦🇺Liverpool, New South Wales, Australia
Calvary Mater Newcastle /ID# 261804
🇦🇺Waratah, New South Wales, Australia
Princess Alexandra Hospital /ID# 261810
🇦🇺Woolloongabba, Queensland, Australia
Monash Medical Centre /ID# 262158
🇦🇺Clayton, Victoria, Australia
St Vincent's Hospital Melbourne /ID# 261808
🇦🇺Fitzroy Melbourne, Victoria, Australia
Box Hill Hospital /ID# 262784
🇦🇺Melbourne, Victoria, Australia
Universitaetsklinikum Krems /ID# 261509
🇦🇹Krems an der Donau, Niederoesterreich, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 245609
🇦🇹Linz, Oberoesterreich, Austria
Medizinische Universitaet Graz /ID# 261908
🇦🇹Graz, Steiermark, Austria
Algemeen Ziekenhuis klina /ID# 260856
🇧🇪Brasschaat, Antwerpen, Belgium
AZ Sint-Jan Brugge /ID# 245345
🇧🇪Brugge, Belgium
Beijing Chaoyang Hospital,Capital Medical University /ID# 245533
🇨🇳Beijing, Beijing, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549
🇨🇳Wuhan, Hubei, China
Institute of Hematology and Blood Diseases Hospital /ID# 265702
🇨🇳Tianjin, Tianjin, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882
🇨🇳Hangzhou, Zhejiang, China
Odense University Hospital /ID# 260924
🇩🇰Odense, Syddanmark, Denmark
Sygehus Lillebalt, Vejle /ID# 260923
🇩🇰Vejle, Syddanmark, Denmark
Ch Saint Quentin /Id# 261856
🇫🇷St Quentin CEDEX, Aisne, France
Centre Hospitalier du Mans /ID# 261852
🇫🇷Le Mans CEDEX 9, Sarthe, France
CH Henri Duffaut /ID# 261844
🇫🇷Avignon CEDEX 9, Vaucluse, France
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 261854
🇫🇷Orléans, France
Universitaetsklinikum Hamburg-Eppendorf /ID# 260651
🇩🇪Hamburg, Germany
Alexandra General Hospital /ID# 240591
🇬🇷Athens, Attiki, Greece
University General Hospital Attikon /ID# 240592
🇬🇷Athens, Attiki, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 240596
🇬🇷Athens, Greece
General University Hospital of Thessaloniki AXEPA /ID# 240595
🇬🇷Thessaloniki, Greece
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648
🇭🇺Gyor, Gyor-Moson-Sopron, Hungary
Semmelweis Egyetem /ID# 261647
🇭🇺Budapest, Hungary
The Chaim Sheba Medical Center /ID# 245497
🇮🇱Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 245495
🇮🇱Tel Aviv, Tel-Aviv, Israel
Shaare Zedek Medical Center /ID# 245681
🇮🇱Jerusalem, Yerushalayim, Israel
Rabin Medical Center /ID# 245498
🇮🇱Haifa, Israel
ASST Ovest Milanese /ID# 256813
🇮🇹Legnano, Milano, Italy
AOU Policlinico G. Rodolico - San Marco /ID# 256814
🇮🇹Catania, Italy
Anjo Kosei Hospital /ID# 263434
🇯🇵Anjo, Aichi, Japan
Nagoya City University Hospital /ID# 263320
🇯🇵Nagoya, Aichi, Japan
Chiba University Hospital /ID# 262006
🇯🇵Chiba-shi, Chiba, Japan
Kyushu University Hospital /ID# 264704
🇯🇵Fukuoka-shi, Fukuoka, Japan
Gifu Municipal Hospital /ID# 263321
🇯🇵Gifu-shi, Gifu, Japan
Gunma University Hospital /ID# 262580
🇯🇵Maebashi-shi, Gunma, Japan
Chugoku Central Hospital /ID# 263431
🇯🇵Fukuyama, Hiroshima, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 262585
🇯🇵Kyoto-shi, Kyoto, Japan
Miyagi Cancer Center /ID# 265094
🇯🇵Natori, Miyagi, Japan
Naha City Hospital /ID# 263972
🇯🇵Naha, Okinawa, Japan
Osaka University Hospital /ID# 263974
🇯🇵Suita-shi, Osaka, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 265696
🇯🇵Amagasaki, Japan
Seoul National University Hospital /ID# 245491
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center /ID# 245492
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Ulsan University Hospital /ID# 245490
🇰🇷Ulsan, Ulsan Gwang Yeogsi, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 245489
🇰🇷Seoul, Korea, Republic of
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168
🇵🇱Lublin, Lubelskie, Poland
Fundacao Champalimaud /ID# 246258
🇵🇹Lisbon, Lisboa, Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 246255
🇵🇹Lisboa, Portugal
Hospital Universitario y Politecnico La Fe /ID# 261625
🇪🇸Valencia, Spain
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 246257
🇵🇹Porto, Portugal
Alberts Cellular Therapy /ID# 245725
🇿🇦Pretoria, Gauteng, South Africa
Constantiaberg Haematology /ID# 261320
🇿🇦Cape Town, Western Cape, South Africa
Haemalife Inc. /ID# 245724
🇿🇦Kuilsrivier, Western Cape, South Africa
Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398
🇪🇸Badalona, Barcelona, Spain
Complejo Hospitalario Universitario Ourense /ID# 246400
🇪🇸Orense, Ourense, Spain
Hospital de Leon /ID# 261624
🇪🇸Leon, Spain
Hospital General Universitario Gregorio Maranon /ID# 246401
🇪🇸Madrid, Spain
Hospital Universitario de Salamanca /ID# 262218
🇪🇸Salamanca, Spain
Helsingborgs Lasarett /ID# 262513
🇸🇪Helsingborg, Skane Lan, Sweden
Uddevalla sjukhus /ID# 262034
🇸🇪Uddevalla, Vastra Gotalands Lan, Sweden
Falu Lasarett /ID# 262231
🇸🇪Falun, Sweden
National Taiwan University Hospital /ID# 245482
🇨🇳Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 245483
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital /ID# 261142
🇨🇳Taichung, Taiwan