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

NCT06232707 | Withdrawn Phase 3 DMC FDA Drug

• 3 other identifiers: CA058-10192023-509472-42U1111-1281-8227
• Study Type: interventional
• Target: N/A
• Locations: 26 countries
• Sites: 166

Brief Summary

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).

Conditions

Multiple Myeloma

Keywords

Relapsed or Refractory Multiple Myeloma; BMS-986349; CC-93269; RRMM; Alnuctamab; CA058-1019; ALUMMINATE RRMM

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Up to 5 years

Secondary Outcomes (15)

• Overall Survival (OS)

  Up to 5 years

• Overall response (OR)

  Up to 5 years

• Complete response (CR) or better

  Up to 5 years

• Very good partial response (VGPR) or better

  Up to 5 years

• Time to response (TTR)

  Up to 5 years

Study Arms (2)

Arm A: Alnuctamab

EXPERIMENTAL

Drug: Alnuctamab

Arm B: Standard of Care Regimens

ACTIVE COMPARATOR

Drug: Pomalidomide; Drug: Daratumumab; Drug: Elotuzumab; Drug: Carfilzomib; Drug: Dexamethasone

Interventions

Alnuctamab DRUG

Specified dose on specified days

Also known as: BMS-986349, CC-93269

Arm A: Alnuctamab

Pomalidomide DRUG

Specified dose on specified days

Also known as: POMALYST®, IMNOVID®, CC-4047, BMS-986379

Arm B: Standard of Care Regimens

Daratumumab DRUG

Specified dose on specified days

Also known as: DARZALEX®, DARZALEX, FASPRO®

Arm B: Standard of Care Regimens

Elotuzumab DRUG

Specified dose on specified days

Also known as: Empliciti®, BMS-901608

Arm B: Standard of Care Regimens

Carfilzomib DRUG

Specified dose on specified days

Also known as: KYPROLIS®

Arm B: Standard of Care Regimens

Dexamethasone DRUG

Specified dose on specified days

Arm B: Standard of Care Regimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (170)

Local Institution - 0151

Birmingham, Alabama, 35294, United States

Location

Local Institution - 0088

Los Angeles, California, 90095, United States

Location

Local Institution - 0358

Stanford, California, 94305, United States

Location

Local Institution - 0355

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0434

Washington D.C., District of Columbia, 20007, United States

Location

Local Institution - 0433

Wichita, Kansas, 67214, United States

Location

Local Institution - 0439

Saint Matthews, Kentucky, 40207, United States

Location

Local Institution - 0323

New Orleans, Louisiana, 70112, United States

Location

Local Institution - 0324

Baltimore, Maryland, 21218, United States

Location

Local Institution - 0441

Bethesda, Maryland, 20889, United States

Location

Local Institution - 0435

Billings, Montana, 59102, United States

Location

Local Institution - 0157

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0359

Summit, New Jersey, 07901, United States

Location

Local Institution - 0430

Lake Success, New York, 11042, United States

Location

Local Institution - 0396

New York, New York, 10065, United States

Location

Local Institution - 0306

Cincinnati, Ohio, 45220, United States

Location

Local Institution - 0199

Cleveland, Ohio, 44109, United States

Location

Local Institution - 0437

Pittsburgh, Pennsylvania, 15224, United States

Location

Local Institution - 0352

Providence, Rhode Island, 02903, United States

Location

Local Institution - 0420

Watertown, South Dakota, 57201, United States

Location

Local Institution - 0168

Dallas, Texas, 75390-88520, United States

Location

Local Institution - 0405

Seattle, Washington, 98109, United States

Location

Local Institution - 0001

La Plata, Buenos Aires, 1900, Argentina

Location

Local Institution - 0262

Pilar, Buenos Aires, 1629, Argentina

Location

Local Institution - 0222

San Juan Bautista, Buenos Aires, 1888, Argentina

Location

Local Institution - 0002

Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina

Location

Local Institution - 0260

Liverpool, New South Wales, 2170, Australia

Location

Local Institution - 0246

Macquarie University, New South Wales, 2109, Australia

Location

Local Institution - 0022

Waratah, New South Wales, 2298, Australia

Location

Local Institution - 0397

Brisbane, Queensland, 4120, Australia

Location

Local Institution - 0021

Box Hill, Victoria, 3128, Australia

Location

Local Institution - 0019

Clayton, Victoria, 3168, Australia

Location

Local Institution - 0018

Melbourne, Victoria, 3004, Australia

Location

Local Institution - 0003

Melbourne, Victoria, 3065, Australia

Location

Local Institution - 0333

Sankt Pölten, Lower Austria, 3100, Austria

Location

Local Institution - 0337

Innsbruck, Tyrol, 6020, Austria

Location

Local Institution - 0334

Salzburg, 5020, Austria

Location

Local Institution - 0332

Vienna, 1090, Austria

Location

Local Institution - 0284

Brasschaat, Antwerpen, 2930, Belgium

Location

Local Institution - 0280

Verviers, Liège, 4800, Belgium

Location

Local Institution - 0279

Yvoir, Namur, 5530, Belgium

Location

Local Institution - 0286

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Local Institution - 0274

Belo Horizonte, Minas Gerais, 30110-022, Brazil

Location

Local Institution - 0351

Natal, Rio Grande do Norte, 59025050, Brazil

Location

Local Institution - 0369

São Paulo, São Paulo, 01509-010, Brazil

Location

Local Institution - 0291

Rio de Janeiro, 22250-905, Brazil

Location

Local Institution - 0211

São Paulo, 05652-900, Brazil

Location

Local Institution - 0417

Calgary, Alberta, T2N 4N2, Canada

Location

Local Institution - 0423

Edmonton, Alberta, T6G1Z2, Canada

Location

Local Institution - 0402

London, Ontario, N6A 5W9, Canada

Location

Local Institution - 0395

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0031

Montreal, Quebec, H1T 2M4, Canada

Location

Local Institution - 0098

Montreal, Quebec, H2X 1P1, Canada

Location

Local Institution - 0027

Santiago, Metropolitana de Santiago, 7580206, Chile

Location

Local Institution - 0030

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Local Institution - 0026

Santiago, Santiago Metropolitan, 7620002, Chile

Location

Local Institution - 0029

Santiago, Santiago Metropolitan, 7650568, Chile

Location

Local Institution - 0413

Beijing, Beijing Municipality, 0, China

Location

Local Institution - 0230

Beijing, Beijing Municipality, 100020, China

Location

Local Institution - 0040

Beijing, Beijing Municipality, 100034, China

Location

Local Institution - 0366

Changping, Beijing Municipality, 102200, China

Location

Local Institution - 0057

Chongqing, Chongqing Municipality, 400016, China

Location

Local Institution - 0066

Guangzhou, Guangdong, 510060, China

Location

Local Institution - 0080

Guangzhou, Guangdong, 510120, China

Location

Local Institution - 0226

Guangzhou, Guangdong, 510515, China

Location

Local Institution - 0368

Shenzhen, Guangdong, 518036, China

Location

Local Institution - 0365

Baoding, Hebei, 071030, China

Location

Local Institution - 0082

Shijiazhuang, Hebei, 050051, China

Location

Local Institution - 0041

Zhengzhou, Henan, 450008, China

Location

Local Institution - 0075

Wuhan, Hubei, 430030, China

Location

Local Institution - 0062

Changsha, Hunan, 410011, China

Location

Local Institution - 0053

Changsha, Hunan, 410013, China

Location

Local Institution - 0055

Nanjing, Jiangsu, 210000, China

Location

Local Institution - 0067

Suzhou, Jiangsu, 215006, China

Location

Local Institution - 0377

Xuzhou, Jiangsu, 221006, China

Location

Local Institution - 0044

Shenyang, Liaoning, 110004, China

Location

Local Institution - 0072

Xi'an, Shaanxi, 710004, China

Location

Local Institution - 0077

Jinan, Shandong, 250014, China

Location

Local Institution - 0083

Jinan, Shandong, 250117, China

Location

Local Institution - 0273

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0421

Shanghai, Shanghai Municipality, 200081, China

Location

Local Institution - 0245

Taiyuan, Shanxi, 030000, China

Location

Local Institution - 0056

Tianjin, Tianjin Municipality, 300052, China

Location

Local Institution - 0422

Tianjin, Tianjin Municipality, 300308, China

Location

Local Institution - 0070

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0203

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0367

Qingdao, 266011, China

Location

Local Institution - 0013

Brno, Brno-město, 625 00, Czechia

Location

Local Institution - 0247

Olomouc, Olomoucký kraj, 779 00, Czechia

Location

Local Institution - 0012

Prague, 12808, Czechia

Location

Local Institution - 0118

Toulouse, Haute-Garonne, 31100, France

Location

Local Institution - 0225

Montpellier, Languedoc-Roussillon, 34295, France

Location

Local Institution - 0224

Vandœuvre-lès-Nancy, Lorraine, 54511, France

Location

Local Institution - 0084

Lille, Nord, 59000, France

Location

Local Institution - 0085

Nantes, Pays de la Loire Region, 44000, France

Location

Local Institution - 0192

Pierre-Bénite, Rhône, 69310, France

Location

Local Institution - 0331

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Local Institution - 0330

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Local Institution - 0335

Dresden, Saxony, 01307, Germany

Location

Local Institution - 0329

Leipzig, Saxony, 04103, Germany

Location

Local Institution - 0339

Hamburg, 22763, Germany

Location

Local Institution - 0004

Athens, Attikí, 115 28, Greece

Location

Local Institution - 0136

Chaïdári, Attikí, 12462, Greece

Location

Local Institution - 0103

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Local Institution - 0108

Szombathely, Vas County, 9700, Hungary

Location

Local Institution - 0104

Budapest, 1088, Hungary

Location

Local Institution - 0105

Budapest, 1097, Hungary

Location

Local Institution - 0370

Visakhapatnam, Andhra Pradesh, 530040, India

Location

Local Institution - 0362

Gurugram, Haryana, 122011, India

Location

Local Institution - 0403

Bangalore, Karnataka, 560092, India

Location

Local Institution - 0399

Lucknow, Uttar Pradesh, 226014, India

Location

Local Institution - 0398

Kolkata, West Bengal, 700094, India

Location

Local Institution - 0281

Cork, T12 E8YV, Ireland

Location

Local Institution - 0371

Dublin, D04 N2E0, Ireland

Location

Local Institution - 0285

Dublin, D08 E9P6, Ireland

Location

Local Institution - 0269

Limerick, V94 F858, Ireland

Location

Local Institution - 0096

Meldola, Emilia-Romagna, 47014, Italy

Location

Local Institution - 0294

Legnano, Milano, 20025, Italy

Location

Local Institution - 0265

Milan, Milano, 20162, Italy

Location

Local Institution - 0410

Palermo, Sicily, 90127, Italy

Location

Local Institution - 0409

Anjo, Aichi-ken, 446-8602, Japan

Location

Local Institution - 0387

Nagoya, Aichi-ken, 467-8602, Japan

Location

Local Institution - 0407

Kamogawa, Chiba, 296-0041, Japan

Location

Local Institution - 0385

Kashiwa, Chiba, 277-8577, Japan

Location

Local Institution - 0386

Isehara, Kanagawa, 259-1193, Japan

Location

Local Institution - 0390

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Local Institution - 0381

Shimotsuga, Tochigi, 321-0293, Japan

Location

Local Institution - 0382

Koto, Tokyo, 135-8550, Japan

Location

Local Institution - 0419

Aomori, 030-8553, Japan

Location

Local Institution - 0383

Chiba, 260-8677, Japan

Location

Local Institution - 0391

Kumamoto, 860-8556, Japan

Location

Local Institution - 0389

Kyoto, 602-8566, Japan

Location

Local Institution - 0388

Okayama, 701-1192, Japan

Location

Local Institution - 0384

Tokyo, 150-8935, Japan

Location

Local Institution - 0137

Løenskog, Akershus, 1474, Norway

Location

Local Institution - 0115

Bergen, Hordaland, 5021, Norway

Location

Local Institution - 0193

Oslo, 0450, Norway

Location

Local Institution - 0242

Lisbon, Lisbon District, 1099-023, Portugal

Location

Local Institution - 0415

Lisbon, Lisbon District, 1649-035, Portugal

Location

Local Institution - 0255

Lisbon, 1500-650, Portugal

Location

Local Institution - 0169

Bucharest, București, 022328, Romania

Location

Local Institution - 0171

Brasov, 500052, Romania

Location

Local Institution - 0414

Bucharest, 050098, Romania

Location

Local Institution - 0240

Seongnam, Kyǒnggi-do, 13620, South Korea

Location

Local Institution - 0221

Busan, Pusan-Kwangyǒkshi, 49201, South Korea

Location

Local Institution - 0036

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

Location

Local Institution - 0239

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Local Institution - 0034

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

Location

Local Institution - 0035

Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea

Location

Local Institution - 0011

Badalona, Barcelona [Barcelona], 08916, Spain

Location

Local Institution - 0234

El Palmar, Murcia, Murcia, Región de, 30120, Spain

Location

Local Institution - 0008

Pamplona, Navarre, 31008, Spain

Location

Local Institution - 0202

Jerez de la Frontera, 11407, Spain

Location

Local Institution - 0006

Salamanca, 37007, Spain

Location

Local Institution - 0007

Santiago de Compostela, 15706, Spain

Location

Local Institution - 0009

Valencia, 46026, Spain

Location

Local Institution - 0114

Borås, Västra Götalands Län [se-14], 501 82, Sweden

Location

Local Institution - 0111

Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden

Location

Local Institution - 0336

Bern, Canton of Bern, 3010, Switzerland

Location

Local Institution - 0411

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Local Institution - 0338

Zurich, 8063, Switzerland

Location

Local Institution - 0325

Stanbul, Istanbul, 34214, Turkey (Türkiye)

Location

Local Institution - 0375

Ankara, 06200, Turkey (Türkiye)

Location

Local Institution - 0188

Izmir, 35100, Turkey (Türkiye)

Location

Local Institution - 0187

Kayseri, 0, Turkey (Türkiye)

Location

Local Institution - 0349

Southampton, Hampshire, SO16 0YD, United Kingdom

Location

Local Institution - 0342

London, London, City of, NW1 2PG, United Kingdom

Location

Local Institution - 0350

Cardiff, CF14 4XW, United Kingdom

Location

Local Institution - 0344

Derby, DE22 3NE, United Kingdom

Location

Local Institution - 0343

Manchester, M20 4BX, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

pomalidomide; daratumumab; elotuzumab; carfilzomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: May 3, 2024
• Primary Completion: November 16, 2025
• Study Completion (Estimated): September 21, 2030
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

AU (8); JP (14); AR (4); CL (4); BE (4); KR (6); CN (30); ES (7); IN (5); CA (6); CZ (3); CH (3); BR (5); GB (5); PT (3); HU (4); IE (4); US (22); FR (6); SE (2); DE (5); RO (3); TU (4); GR (2); IT (4); NO (3)