Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

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
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.

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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ABBV-383ABBV-383Participants will receive ABBV-383 as a monotherapy.
Standard Available Therapy (SAT)SelinexorParticipants 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)BortezomibParticipants 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)PomalidomideParticipants 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)CarfilzomibParticipants 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)ElotuzumabParticipants 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)DexamethasoneParticipants 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
NameTimeMethod
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
NameTimeMethod
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-MY20Up 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 >= CRUp 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-C30Up 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

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Hangzhou, Zhejiang, China

Alta Bates Summit Medical Center for Research /ID# 261438

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Berkeley, California, United States

Providence - St. Jude Medical Center /ID# 262031

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Fullerton, California, United States

Cancer Specialists of North Florida /ID# 246230

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Jacksonville, Florida, United States

University of Illinois at Chicago /ID# 246349

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Chicago, Illinois, United States

Springfield Clinic /ID# 262266

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Springfield, Illinois, United States

Center for Cancer and Blood Disorders /ID# 263637

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Bethesda, Maryland, United States

New York Cancer & Blood Specialists - Bay Shore /ID# 261524

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Bay Shore, New York, United States

Eastchester Center for Cancer Care /ID# 262952

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Bronx, New York, United States

New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953

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New Hyde Park, New York, United States

New York Cancer and Blood Specialists - New York /ID# 262951

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New York, New York, United States

Virginia Cancer Specialists - Fairfax /ID# 262792

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Fairfax, Virginia, United States

St George Hospital /ID# 261806

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Kogarah, New South Wales, Australia

Liverpool Hospital /ID# 262159

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Liverpool, New South Wales, Australia

Calvary Mater Newcastle /ID# 261804

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Waratah, New South Wales, Australia

Princess Alexandra Hospital /ID# 261810

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Woolloongabba, Queensland, Australia

Monash Medical Centre /ID# 262158

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Clayton, Victoria, Australia

St Vincent's Hospital Melbourne /ID# 261808

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Fitzroy Melbourne, Victoria, Australia

Box Hill Hospital /ID# 262784

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Melbourne, Victoria, Australia

Universitaetsklinikum Krems /ID# 261509

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Krems an der Donau, Niederoesterreich, Austria

Ordensklinikum Linz GmbH Elisabethinen /ID# 245609

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Linz, Oberoesterreich, Austria

Medizinische Universitaet Graz /ID# 261908

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Graz, Steiermark, Austria

Algemeen Ziekenhuis klina /ID# 260856

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Brasschaat, Antwerpen, Belgium

AZ Sint-Jan Brugge /ID# 245345

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Brugge, Belgium

Beijing Chaoyang Hospital,Capital Medical University /ID# 245533

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Beijing, Beijing, China

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549

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Wuhan, Hubei, China

Institute of Hematology and Blood Diseases Hospital /ID# 265702

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Tianjin, Tianjin, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882

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Hangzhou, Zhejiang, China

Odense University Hospital /ID# 260924

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Odense, Syddanmark, Denmark

Sygehus Lillebalt, Vejle /ID# 260923

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Vejle, Syddanmark, Denmark

Ch Saint Quentin /Id# 261856

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St Quentin CEDEX, Aisne, France

Centre Hospitalier du Mans /ID# 261852

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Le Mans CEDEX 9, Sarthe, France

CH Henri Duffaut /ID# 261844

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Avignon CEDEX 9, Vaucluse, France

Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 261854

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Orléans, France

Universitaetsklinikum Hamburg-Eppendorf /ID# 260651

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Hamburg, Germany

Alexandra General Hospital /ID# 240591

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Athens, Attiki, Greece

University General Hospital Attikon /ID# 240592

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Athens, Attiki, Greece

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 240596

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Athens, Greece

General University Hospital of Thessaloniki AXEPA /ID# 240595

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Thessaloniki, Greece

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648

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Gyor, Gyor-Moson-Sopron, Hungary

Semmelweis Egyetem /ID# 261647

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Budapest, Hungary

The Chaim Sheba Medical Center /ID# 245497

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Ramat Gan, Tel-Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 245495

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Tel Aviv, Tel-Aviv, Israel

Shaare Zedek Medical Center /ID# 245681

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Jerusalem, Yerushalayim, Israel

Rabin Medical Center /ID# 245498

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Haifa, Israel

ASST Ovest Milanese /ID# 256813

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Legnano, Milano, Italy

AOU Policlinico G. Rodolico - San Marco /ID# 256814

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Catania, Italy

Anjo Kosei Hospital /ID# 263434

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Anjo, Aichi, Japan

Nagoya City University Hospital /ID# 263320

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Nagoya, Aichi, Japan

Chiba University Hospital /ID# 262006

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Chiba-shi, Chiba, Japan

Kyushu University Hospital /ID# 264704

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Fukuoka-shi, Fukuoka, Japan

Gifu Municipal Hospital /ID# 263321

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Gifu-shi, Gifu, Japan

Gunma University Hospital /ID# 262580

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Maebashi-shi, Gunma, Japan

Chugoku Central Hospital /ID# 263431

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Fukuyama, Hiroshima, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 262585

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Kyoto-shi, Kyoto, Japan

Miyagi Cancer Center /ID# 265094

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Natori, Miyagi, Japan

Naha City Hospital /ID# 263972

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Naha, Okinawa, Japan

Osaka University Hospital /ID# 263974

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Suita-shi, Osaka, Japan

Hyogo Prefectural Amagasaki General Medical Center /ID# 265696

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Amagasaki, Japan

Seoul National University Hospital /ID# 245491

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Seoul, Seoul Teugbyeolsi, Korea, Republic of

Samsung Medical Center /ID# 245492

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Seoul, Seoul Teugbyeolsi, Korea, Republic of

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493

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Seoul, Seoul Teugbyeolsi, Korea, Republic of

Ulsan University Hospital /ID# 245490

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Ulsan, Ulsan Gwang Yeogsi, Korea, Republic of

Yonsei University Health System Severance Hospital /ID# 245489

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Seoul, Korea, Republic of

Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168

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Lublin, Lubelskie, Poland

Fundacao Champalimaud /ID# 246258

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Lisbon, Lisboa, Portugal

Unidade Local de Saude de Santa Maria, EPE /ID# 246255

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Lisboa, Portugal

Hospital Universitario y Politecnico La Fe /ID# 261625

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Valencia, Spain

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 246257

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Porto, Portugal

Alberts Cellular Therapy /ID# 245725

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Pretoria, Gauteng, South Africa

Constantiaberg Haematology /ID# 261320

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Cape Town, Western Cape, South Africa

Haemalife Inc. /ID# 245724

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Kuilsrivier, Western Cape, South Africa

Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398

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Badalona, Barcelona, Spain

Complejo Hospitalario Universitario Ourense /ID# 246400

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Orense, Ourense, Spain

Hospital de Leon /ID# 261624

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Leon, Spain

Hospital General Universitario Gregorio Maranon /ID# 246401

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Madrid, Spain

Hospital Universitario de Salamanca /ID# 262218

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Salamanca, Spain

Helsingborgs Lasarett /ID# 262513

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Helsingborg, Skane Lan, Sweden

Uddevalla sjukhus /ID# 262034

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Uddevalla, Vastra Gotalands Lan, Sweden

Falu Lasarett /ID# 262231

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Falun, Sweden

National Taiwan University Hospital /ID# 245482

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Taipei City, Taipei, Taiwan

China Medical University Hospital /ID# 245483

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Taichung, Taiwan

Taichung Veterans General Hospital /ID# 261142

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Taichung, Taiwan

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