A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT ID: NCT06232707

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-03

Study Completion Date

2030-09-21

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: Alnuctamab

Group Type EXPERIMENTAL

Alnuctamab

Intervention Type DRUG

Specified dose on specified days

Arm B: Standard of Care Regimens

Group Type ACTIVE_COMPARATOR

Pomalidomide

Intervention Type DRUG

Specified dose on specified days

Daratumumab

Intervention Type DRUG

Specified dose on specified days

Elotuzumab

Intervention Type DRUG

Specified dose on specified days

Carfilzomib

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Interventions

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Alnuctamab

Specified dose on specified days

Intervention Type DRUG

Pomalidomide

Specified dose on specified days

Intervention Type DRUG

Daratumumab

Specified dose on specified days

Intervention Type DRUG

Elotuzumab

Specified dose on specified days

Intervention Type DRUG

Carfilzomib

Specified dose on specified days

Intervention Type DRUG

Dexamethasone

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986349 CC-93269 POMALYST® IMNOVID® CC-4047 BMS-986379 DARZALEX® DARZALEX FASPRO® Empliciti® BMS-901608 KYPROLIS®

Eligibility Criteria

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Inclusion Criteria

* Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.
* Documented diagnosis of multiple myeloma (MM), and must:.

i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.

ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).

iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.

iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.

* Must have measurable disease (as determined by central laboratory).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening.

Exclusion Criteria

* Active, uncontrolled, or suspected infection.
* Known current, or history of, central nervous system involvement of multiple myeloma.
* History or presence of clinically relevant CNS pathology.
* Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
* Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0151

Birmingham, Alabama, United States

Site Status

Local Institution - 0088

Los Angeles, California, United States

Site Status

Local Institution - 0358

Stanford, California, United States

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Local Institution - 0355

New Haven, Connecticut, United States

Site Status

Local Institution - 0434

Washington D.C., District of Columbia, United States

Site Status

Local Institution - 0433

Wichita, Kansas, United States

Site Status

Local Institution - 0439

Saint Matthews, Kentucky, United States

Site Status

Local Institution - 0323

New Orleans, Louisiana, United States

Site Status

Local Institution - 0324

Baltimore, Maryland, United States

Site Status

Local Institution - 0441

Bethesda, Maryland, United States

Site Status

Local Institution - 0435

Billings, Montana, United States

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Local Institution - 0157

Hackensack, New Jersey, United States

Site Status

Local Institution - 0359

Summit, New Jersey, United States

Site Status

Local Institution - 0430

Lake Success, New York, United States

Site Status

Local Institution - 0396

New York, New York, United States

Site Status

Local Institution - 0306

Cincinnati, Ohio, United States

Site Status

Local Institution - 0199

Cleveland, Ohio, United States

Site Status

Local Institution - 0437

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0352

Providence, Rhode Island, United States

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Local Institution - 0420

Watertown, South Dakota, United States

Site Status

Local Institution - 0168

Dallas, Texas, United States

Site Status

Local Institution - 0405

Seattle, Washington, United States

Site Status

Local Institution - 0001

La Plata, Buenos Aires, Argentina

Site Status

Local Institution - 0262

Pilar, Buenos Aires, Argentina

Site Status

Local Institution - 0222

San Juan Bautista, Buenos Aires, Argentina

Site Status

Local Institution - 0002

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Local Institution - 0260

Liverpool, New South Wales, Australia

Site Status

Local Institution - 0246

Macquarie University, New South Wales, Australia

Site Status

Local Institution - 0022

Waratah, New South Wales, Australia

Site Status

Local Institution - 0397

Brisbane, Queensland, Australia

Site Status

Local Institution - 0021

Box Hill, Victoria, Australia

Site Status

Local Institution - 0019

Clayton, Victoria, Australia

Site Status

Local Institution - 0018

Melbourne, Victoria, Australia

Site Status

Local Institution - 0003

Melbourne, Victoria, Australia

Site Status

Local Institution - 0333

Sankt Pölten, Lower Austria, Austria

Site Status

Local Institution - 0337

Innsbruck, Tyrol, Austria

Site Status

Local Institution - 0334

Salzburg, , Austria

Site Status

Local Institution - 0332

Vienna, , Austria

Site Status

Local Institution - 0284

Brasschaat, Antwerpen, Belgium

Site Status

Local Institution - 0280

Verviers, Liège, Belgium

Site Status

Local Institution - 0279

Yvoir, Namur, Belgium

Site Status

Local Institution - 0286

Leuven, Vlaams-Brabant, Belgium

Site Status

Local Institution - 0274

Belo Horizonte, Minas Gerais, Brazil

Site Status

Local Institution - 0351

Natal, Rio Grande do Norte, Brazil

Site Status

Local Institution - 0369

São Paulo, São Paulo, Brazil

Site Status

Local Institution - 0291

Rio de Janeiro, , Brazil

Site Status

Local Institution - 0211

São Paulo, , Brazil

Site Status

Local Institution - 0417

Calgary, Alberta, Canada

Site Status

Local Institution - 0423

Edmonton, Alberta, Canada

Site Status

Local Institution - 0402

London, Ontario, Canada

Site Status

Local Institution - 0395

Toronto, Ontario, Canada

Site Status

Local Institution - 0031

Montreal, Quebec, Canada

Site Status

Local Institution - 0098

Montreal, Quebec, Canada

Site Status

Local Institution - 0027

Santiago, Metropolitana de Santiago, Chile

Site Status

Local Institution - 0030

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0026

Santiago, Santiago Metropolitan, Chile

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Local Institution - 0029

Santiago, Santiago Metropolitan, Chile

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Local Institution - 0413

Beijing, Beijing Municipality, China

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Local Institution - 0230

Beijing, Beijing Municipality, China

Site Status

Local Institution - 0040

Beijing, Beijing Municipality, China

Site Status

Local Institution - 0366

Changping, Beijing Municipality, China

Site Status

Local Institution - 0057

Chongqing, Chongqing Municipality, China

Site Status

Local Institution - 0066

Guangzhou, Guangdong, China

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Local Institution - 0080

Guangzhou, Guangdong, China

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Local Institution - 0226

Guangzhou, Guangdong, China

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Local Institution - 0368

Shenzhen, Guangdong, China

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Local Institution - 0365

Baoding, Hebei, China

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Local Institution - 0082

Shijiazhuang, Hebei, China

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Local Institution - 0041

Zhengzhou, Henan, China

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Local Institution - 0075

Wuhan, Hubei, China

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Local Institution - 0062

Changsha, Hunan, China

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Local Institution - 0053

Changsha, Hunan, China

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Local Institution - 0055

Nanjing, Jiangsu, China

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Local Institution - 0067

Suzhou, Jiangsu, China

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Local Institution - 0377

Xuzhou, Jiangsu, China

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Local Institution - 0044

Shenyang, Liaoning, China

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Local Institution - 0072

Xi'an, Shaanxi, China

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Local Institution - 0077

Jinan, Shandong, China

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Local Institution - 0083

Jinan, Shandong, China

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Local Institution - 0273

Shanghai, Shanghai Municipality, China

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Local Institution - 0421

Shanghai, Shanghai Municipality, China

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Local Institution - 0245

Taiyuan, Shanxi, China

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Local Institution - 0056

Tianjin, Tianjin Municipality, China

Site Status

Local Institution - 0422

Tianjin, Tianjin Municipality, China

Site Status

Local Institution - 0070

Hangzhou, Zhejiang, China

Site Status

Local Institution - 0203

Hangzhou, Zhejiang, China

Site Status

Local Institution - 0367

Qingdao, , China

Site Status

Local Institution - 0013

Brno, Brno-město, Czechia

Site Status

Local Institution - 0247

Olomouc, Olomoucký kraj, Czechia

Site Status

Local Institution - 0012

Prague, , Czechia

Site Status

Local Institution - 0118

Toulouse, Haute-Garonne, France

Site Status

Local Institution - 0225

Montpellier, Languedoc-Roussillon, France

Site Status

Local Institution - 0224

Vandœuvre-lès-Nancy, Lorraine, France

Site Status

Local Institution - 0084

Lille, Nord, France

Site Status

Local Institution - 0085

Nantes, Pays de la Loire Region, France

Site Status

Local Institution - 0192

Pierre-Bénite, Rhône, France

Site Status

Local Institution - 0331

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Local Institution - 0330

Tübingen, Baden-Wurttemberg, Germany

Site Status

Local Institution - 0335

Dresden, Saxony, Germany

Site Status

Local Institution - 0329

Leipzig, Saxony, Germany

Site Status

Local Institution - 0339

Hamburg, , Germany

Site Status

Local Institution - 0004

Athens, Attikí, Greece

Site Status

Local Institution - 0136

Chaïdári, Attikí, Greece

Site Status

Local Institution - 0103

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Site Status

Local Institution - 0108

Szombathely, Vas County, Hungary

Site Status

Local Institution - 0104

Budapest, , Hungary

Site Status

Local Institution - 0105

Budapest, , Hungary

Site Status

Local Institution - 0370

Visakhapatnam, Andhra Pradesh, India

Site Status

Local Institution - 0362

Gurugram, Haryana, India

Site Status

Local Institution - 0403

Bangalore, Karnataka, India

Site Status

Local Institution - 0399

Lucknow, Uttar Pradesh, India

Site Status

Local Institution - 0398

Kolkata, West Bengal, India

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Local Institution - 0281

Cork, , Ireland

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Local Institution - 0371

Dublin, , Ireland

Site Status

Local Institution - 0285

Dublin, , Ireland

Site Status

Local Institution - 0269

Limerick, , Ireland

Site Status

Local Institution - 0096

Meldola, Emilia-Romagna, Italy

Site Status

Local Institution - 0294

Legnano, Milano, Italy

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Local Institution - 0265

Milan, Milano, Italy

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Local Institution - 0410

Palermo, Sicily, Italy

Site Status

Local Institution - 0409

Anjo, Aichi-ken, Japan

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Local Institution - 0387

Nagoya, Aichi-ken, Japan

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Local Institution - 0407

Kamogawa, Chiba, Japan

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Local Institution - 0385

Kashiwa, Chiba, Japan

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Local Institution - 0386

Isehara, Kanagawa, Japan

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Local Institution - 0390

Ōsaka-sayama, Osaka, Japan

Site Status

Local Institution - 0381

Shimotsuga, Tochigi, Japan

Site Status

Local Institution - 0382

Koto, Tokyo, Japan

Site Status

Local Institution - 0419

Aomori, , Japan

Site Status

Local Institution - 0383

Chiba, , Japan

Site Status

Local Institution - 0391

Kumamoto, , Japan

Site Status

Local Institution - 0389

Kyoto, , Japan

Site Status

Local Institution - 0388

Okayama, , Japan

Site Status

Local Institution - 0384

Tokyo, , Japan

Site Status

Local Institution - 0137

Løenskog, Akershus, Norway

Site Status

Local Institution - 0115

Bergen, Hordaland, Norway

Site Status

Local Institution - 0193

Oslo, , Norway

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Local Institution - 0242

Lisbon, Lisbon District, Portugal

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Local Institution - 0415

Lisbon, Lisbon District, Portugal

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Local Institution - 0255

Lisbon, , Portugal

Site Status

Local Institution - 0169

Bucharest, București, Romania

Site Status

Local Institution - 0171

Brasov, , Romania

Site Status

Local Institution - 0414

Bucharest, , Romania

Site Status

Local Institution - 0240

Seongnam, Kyǒnggi-do, South Korea

Site Status

Local Institution - 0221

Busan, Pusan-Kwangyǒkshi, South Korea

Site Status

Local Institution - 0036

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Local Institution - 0239

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Local Institution - 0034

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Local Institution - 0035

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Local Institution - 0011

Badalona, Barcelona [Barcelona], Spain

Site Status

Local Institution - 0234

El Palmar, Murcia, Murcia, Región de, Spain

Site Status

Local Institution - 0008

Pamplona, Navarre, Spain

Site Status

Local Institution - 0202

Jerez de la Frontera, , Spain

Site Status

Local Institution - 0006

Salamanca, , Spain

Site Status

Local Institution - 0007

Santiago de Compostela, , Spain

Site Status

Local Institution - 0009

Valencia, , Spain

Site Status

Local Institution - 0114

Borås, Västra Götalands Län [se-14], Sweden

Site Status

Local Institution - 0111

Gothenburg, Västra Götalands Län [se-14], Sweden

Site Status

Local Institution - 0336

Bern, Canton of Bern, Switzerland

Site Status

Local Institution - 0411

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status

Local Institution - 0338

Zurich, , Switzerland

Site Status

Local Institution - 0325

Stanbul, Istanbul, Turkey (Türkiye)

Site Status

Local Institution - 0375

Ankara, , Turkey (Türkiye)

Site Status

Local Institution - 0188

Izmir, , Turkey (Türkiye)

Site Status

Local Institution - 0187

Kayseri, , Turkey (Türkiye)

Site Status

Local Institution - 0349

Southampton, Hampshire, United Kingdom

Site Status

Local Institution - 0342

London, London, City of, United Kingdom

Site Status

Local Institution - 0350

Cardiff, , United Kingdom

Site Status

Local Institution - 0344

Derby, , United Kingdom

Site Status

Local Institution - 0343

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Canada Chile China Czechia France Germany Greece Hungary India Ireland Italy Japan Norway Portugal Romania South Korea Spain Sweden Switzerland Turkey (Türkiye) United Kingdom

Related Links

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Other Identifiers

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2023-509472-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1281-8227

Identifier Type: REGISTRY

Identifier Source: secondary_id

CA058-1019

Identifier Type: -

Identifier Source: org_study_id

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