AzTrials
AzTrials

Multiple MyelomaPhase 3ALUMMINATENCT06232707

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

A Phase 3 study testing Alnuctamab, Pomalidomide and Daratumumab in people with Multiple Myeloma, run by Celgene at 170 sites in 27 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Alnuctamab, Pomalidomide and Daratumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
170 sitesin 27 countries
Study dates
3 May 2024to 21 Sep 2030
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:.
  • Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.
  • Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).
  • Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.
  • 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.

Who cannot join

  • 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

170 sites in 27 countries.

170 sites in 27 countries

China30 sites

  • Local Institution - 0365

    Baoding, Hebei, 071030

  • Local Institution - 0413

    Beijing, Beijing Municipality, 0

  • Local Institution - 0230

    Beijing, Beijing Municipality, 100020

  • Local Institution - 0040

    Beijing, Beijing Municipality, 100034

  • Local Institution - 0366

    Changping, Beijing Municipality, 102200

  • Local Institution - 0062

    Changsha, Hunan, 410011

  • Local Institution - 0053

    Changsha, Hunan, 410013

  • Local Institution - 0057

    Chongqing, Chongqing Municipality, 400016

  • Local Institution - 0066

    Guangzhou, Guangdong, 510060

  • Local Institution - 0080

    Guangzhou, Guangdong, 510120

  • Local Institution - 0226

    Guangzhou, Guangdong, 510515

  • Local Institution - 0070

    Hangzhou, Zhejiang, 310003

  • Local Institution - 0203

    Hangzhou, Zhejiang, 310003

  • Local Institution - 0077

    Jinan, Shandong, 250014

  • Local Institution - 0083

    Jinan, Shandong, 250117

  • Local Institution - 0055

    Nanjing, Jiangsu, 210000

  • Local Institution - 0367

    Qingdao, 266011

  • Local Institution - 0273

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0421

    Shanghai, Shanghai Municipality, 200081

  • Local Institution - 0044

    Shenyang, Liaoning, 110004

  • Local Institution - 0368

    Shenzhen, Guangdong, 518036

  • Local Institution - 0082

    Shijiazhuang, Hebei, 050051

  • Local Institution - 0067

    Suzhou, Jiangsu, 215006

  • Local Institution - 0245

    Taiyuan, Shanxi, 030000

  • Local Institution - 0056

    Tianjin, Tianjin Municipality, 300052

  • Local Institution - 0422

    Tianjin, Tianjin Municipality, 300308

  • Local Institution - 0075

    Wuhan, Hubei, 430030

  • Local Institution - 0072

    Xi'an, Shaanxi, 710004

  • Local Institution - 0377

    Xuzhou, Jiangsu, 221006

  • Local Institution - 0041

    Zhengzhou, Henan, 450008

Other trials in China

United States22 sites

  • Local Institution - 0324

    Baltimore, Maryland, 21218

  • Local Institution - 0441

    Bethesda, Maryland, 20889

  • Local Institution - 0435

    Billings, Montana, 59102

  • Local Institution - 0151

    Birmingham, Alabama, 35294

  • Local Institution - 0306

    Cincinnati, Ohio, 45220

  • Local Institution - 0199

    Cleveland, Ohio, 44109

  • Local Institution - 0168

    Dallas, Texas, 75390-88520

  • Local Institution - 0157

    Hackensack, New Jersey, 07601

  • Local Institution - 0430

    Lake Success, New York, 11042

  • Local Institution - 0088

    Los Angeles, California, 90095

  • Local Institution - 0355

    New Haven, Connecticut, 06520

  • Local Institution - 0323

    New Orleans, Louisiana, 70112

  • Local Institution - 0396

    New York, New York, 10065

  • Local Institution - 0437

    Pittsburgh, Pennsylvania, 15224

  • Local Institution - 0352

    Providence, Rhode Island, 02903

  • Local Institution - 0439

    Saint Matthews, Kentucky, 40207

  • Local Institution - 0405

    Seattle, Washington, 98109

  • Local Institution - 0358

    Stanford, California, 94305

  • Local Institution - 0359

    Summit, New Jersey, 07901

  • Local Institution - 0434

    Washington D.C., District of Columbia, 20007

  • Local Institution - 0420

    Watertown, South Dakota, 57201

  • Local Institution - 0433

    Wichita, Kansas, 67214

Other trials in United States

Japan14 sites

  • Local Institution - 0409

    Anjo, Aichi-ken, 446-8602

  • Local Institution - 0419

    Aomori, 030-8553

  • Local Institution - 0383

    Chiba, 260-8677

  • Local Institution - 0386

    Isehara, Kanagawa, 259-1193

  • Local Institution - 0407

    Kamogawa, Chiba, 296-0041

  • Local Institution - 0385

    Kashiwa, Chiba, 277-8577

  • Local Institution - 0382

    Koto, Tokyo, 135-8550

  • Local Institution - 0391

    Kumamoto, 860-8556

  • Local Institution - 0389

    Kyoto, 602-8566

  • Local Institution - 0387

    Nagoya, Aichi-ken, 467-8602

  • Local Institution - 0388

    Okayama, 701-1192

  • Local Institution - 0390

    Ōsaka-sayama, Osaka, 589-8511

  • Local Institution - 0381

    Shimotsuga, Tochigi, 321-0293

  • Local Institution - 0384

    Tokyo, 150-8935

Other trials in Japan

Australia8 sites

  • Local Institution - 0021

    Box Hill, Victoria, 3128

  • Local Institution - 0397

    Brisbane, Queensland, 4120

  • Local Institution - 0019

    Clayton, Victoria, 3168

  • Local Institution - 0260

    Liverpool, New South Wales, 2170

  • Local Institution - 0246

    Macquarie University, New South Wales, 2109

  • Local Institution - 0018

    Melbourne, Victoria, 3004

  • Local Institution - 0003

    Melbourne, Victoria, 3065

  • Local Institution - 0022

    Waratah, New South Wales, 2298

Other trials in Australia

Spain7 sites

  • Local Institution - 0011

    Badalona, Barcelona [Barcelona], 08916

  • Local Institution - 0234

    El Palmar, Murcia, Murcia, Región de, 30120

  • Local Institution - 0202

    Jerez de la Frontera, 11407

  • Local Institution - 0008

    Pamplona, Navarre, 31008

  • Local Institution - 0006

    Salamanca, 37007

  • Local Institution - 0007

    Santiago de Compostela, 15706

  • Local Institution - 0009

    Valencia, 46026

Other trials in Spain

Canada6 sites

  • Local Institution - 0417

    Calgary, Alberta, T2N 4N2

  • Local Institution - 0423

    Edmonton, Alberta, T6G1Z2

  • Local Institution - 0402

    London, Ontario, N6A 5W9

  • Local Institution - 0031

    Montreal, Quebec, H1T 2M4

  • Local Institution - 0098

    Montreal, Quebec, H2X 1P1

  • Local Institution - 0395

    Toronto, Ontario, M5G 2M9

Other trials in Canada

France6 sites

  • Local Institution - 0084

    Lille, Nord, 59000

  • Local Institution - 0225

    Montpellier, Languedoc-Roussillon, 34295

  • Local Institution - 0085

    Nantes, Pays de la Loire Region, 44000

  • Local Institution - 0192

    Pierre-Bénite, Rhône, 69310

  • Local Institution - 0118

    Toulouse, Haute-Garonne, 31100

  • Local Institution - 0224

    Vandœuvre-lès-Nancy, Lorraine, 54511

Other trials in France

South Korea6 sites

  • Local Institution - 0221

    Busan, Pusan-Kwangyǒkshi, 49201

  • Local Institution - 0240

    Seongnam, Kyǒnggi-do, 13620

  • Local Institution - 0036

    Seoul, Seoul-teukbyeolsi [Seoul], 03080

  • Local Institution - 0239

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Local Institution - 0034

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

  • Local Institution - 0035

    Seoul, Seoul-teukbyeolsi [Seoul], 06591

Other trials in South Korea

Brazil5 sites

  • Local Institution - 0274

    Belo Horizonte, Minas Gerais, 30110-022

  • Local Institution - 0351

    Natal, Rio Grande do Norte, 59025050

  • Local Institution - 0291

    Rio de Janeiro, 22250-905

  • Local Institution - 0369

    São Paulo, São Paulo, 01509-010

  • Local Institution - 0211

    São Paulo, 05652-900

Other trials in Brazil

Germany5 sites

  • Local Institution - 0335

    Dresden, Saxony, 01307

  • Local Institution - 0339

    Hamburg, 22763

  • Local Institution - 0331

    Heidelberg, Baden-Wurttemberg, 69120

  • Local Institution - 0329

    Leipzig, Saxony, 04103

  • Local Institution - 0330

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

India5 sites

  • Local Institution - 0403

    Bangalore, Karnataka, 560092

  • Local Institution - 0362

    Gurugram, Haryana, 122011

  • Local Institution - 0398

    Kolkata, West Bengal, 700094

  • Local Institution - 0399

    Lucknow, Uttar Pradesh, 226014

  • Local Institution - 0370

    Visakhapatnam, Andhra Pradesh, 530040

Other trials in India

United Kingdom5 sites

  • Local Institution - 0350

    Cardiff, CF14 4XW

  • Local Institution - 0344

    Derby, DE22 3NE

  • Local Institution - 0342

    London, London, City of, NW1 2PG

  • Local Institution - 0343

    Manchester, M20 4BX

  • Local Institution - 0349

    Southampton, Hampshire, SO16 0YD

Other trials in United Kingdom

Argentina4 sites

  • Local Institution - 0002

    Buenos Aires, Buenos Aires F.D., C1118AAT

  • Local Institution - 0001

    La Plata, Buenos Aires, 1900

  • Local Institution - 0262

    Pilar, Buenos Aires, 1629

  • Local Institution - 0222

    San Juan Bautista, Buenos Aires, 1888

Other trials in Argentina

Austria4 sites

  • Local Institution - 0337

    Innsbruck, Tyrol, 6020

  • Local Institution - 0334

    Salzburg, 5020

  • Local Institution - 0333

    Sankt Pölten, Lower Austria, 3100

  • Local Institution - 0332

    Vienna, 1090

Other trials in Austria

Belgium4 sites

  • Local Institution - 0284

    Brasschaat, Antwerpen, 2930

  • Local Institution - 0286

    Leuven, Vlaams-Brabant, 3000

  • Local Institution - 0280

    Verviers, Liège, 4800

  • Local Institution - 0279

    Yvoir, Namur, 5530

Other trials in Belgium

Chile4 sites

  • Local Institution - 0027

    Santiago, Metropolitana de Santiago, 7580206

  • Local Institution - 0030

    Santiago, Santiago Metropolitan, 7500921

  • Local Institution - 0026

    Santiago, Santiago Metropolitan, 7620002

  • Local Institution - 0029

    Santiago, Santiago Metropolitan, 7650568

Other trials in Chile

Hungary4 sites

  • Local Institution - 0104

    Budapest, 1088

  • Local Institution - 0105

    Budapest, 1097

  • Local Institution - 0103

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Local Institution - 0108

    Szombathely, Vas County, 9700

Other trials in Hungary

Ireland4 sites

  • Local Institution - 0281

    Cork, T12 E8YV

  • Local Institution - 0371

    Dublin, D04 N2E0

  • Local Institution - 0285

    Dublin, D08 E9P6

  • Local Institution - 0269

    Limerick, V94 F858

Other trials in Ireland

Italy4 sites

  • Local Institution - 0294

    Legnano, Milano, 20025

  • Local Institution - 0096

    Meldola, Emilia-Romagna, 47014

  • Local Institution - 0265

    Milan, Milano, 20162

  • Local Institution - 0410

    Palermo, Sicily, 90127

Other trials in Italy

Turkey (Türkiye)4 sites

  • Local Institution - 0375

    Ankara, 06200

  • Local Institution - 0188

    Izmir, 35100

  • Local Institution - 0187

    Kayseri, 0

  • Local Institution - 0325

    Stanbul, Istanbul, 34214

Other trials in Turkey (Türkiye)

Czechia3 sites

  • Local Institution - 0013

    Brno, Brno-město, 625 00

  • Local Institution - 0247

    Olomouc, Olomouc Region, 779 00

  • Local Institution - 0012

    Prague, 12808

Other trials in Czechia

Norway3 sites

  • Local Institution - 0115

    Bergen, Hordaland, 5021

  • Local Institution - 0137

    Løenskog, Akershus, 1474

  • Local Institution - 0193

    Oslo, 0450

Other trials in Norway

Portugal3 sites

  • Local Institution - 0242

    Lisbon, Lisbon District, 1099-023

  • Local Institution - 0415

    Lisbon, Lisbon District, 1649-035

  • Local Institution - 0255

    Lisbon, 1500-650

Other trials in Portugal

Romania3 sites

  • Local Institution - 0171

    Brasov, 500052

  • Local Institution - 0169

    Bucharest, Bucharest, 022328

  • Local Institution - 0414

    Bucharest, 050098

Other trials in Romania

Switzerland3 sites

  • Local Institution - 0336

    Bern, Canton of Bern, 3010

  • Local Institution - 0411

    Sankt Gallen, Canton of St. Gallen, 9007

  • Local Institution - 0338

    Zurich, 8063

Other trials in Switzerland

Greece2 sites

  • Local Institution - 0004

    Athens, Attikí, 115 28

  • Local Institution - 0136

    Chaïdári, Attikí, 12462

Other trials in Greece

Sweden2 sites

  • Local Institution - 0114

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

  • Local Institution - 0111

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

Other trials in Sweden

About this study

Official title: A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM

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).

Being tested
Alnuctamab, Pomalidomide, Daratumumab, Elotuzumab, Carfilzomib
Keywords
Relapsed or Refractory Multiple Myeloma, BMS-986349, CC-93269, RRMM, Alnuctamab, CA058-1019, ALUMMINATE RRMM
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlnuctamabDrug

    Also called BMS-986349, CC-93269

    Specified dose on specified days

  • PomalidomideDrug

    Also called POMALYST®, IMNOVID®, CC-4047, BMS-986379

    Specified dose on specified days

  • DaratumumabDrug

    Also called DARZALEX®, DARZALEX, FASPRO®

    Specified dose on specified days

  • ElotuzumabDrug

    Also called Empliciti®, BMS-901608

    Specified dose on specified days

  • CarfilzomibDrug

    Also called KYPROLIS®

    Specified dose on specified days

  • DexamethasoneDrug

    Specified dose on specified days

Study groups in NCT06232707
Study groupRoleWhat they receive
Arm A: AlnuctamabExperimentalNot described
Receives: Drug: Alnuctamab
Arm B: Standard of Care RegimensActive comparatorNot described
Receives: Drug: Pomalidomide; Drug: Daratumumab; Drug: Elotuzumab; Drug: Carfilzomib; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    Measured: Up to 5 years

Secondary outcomes (15)

  1. Overall Survival (OS)

    Measured: Up to 5 years

  2. Overall response (OR)

    Measured: Up to 5 years

  3. Complete response (CR) or better

    Measured: Up to 5 years

  4. Very good partial response (VGPR) or better

    Measured: Up to 5 years

  5. Time to response (TTR)

    Measured: Up to 5 years

  6. Duration of response (DOR)

    Measured: Up to 5 years

  7. Time to progression (TTP)

    Measured: Up to 5 years

  8. Time to next treatment (TTNT)

    Measured: Up to 5 years

  9. Progression-free survival 2 (PFS2)

    Measured: Up to 5 years

  10. Restricted mean DOR (RMDOR)

    Measured: Up to 5 years

  11. Minimal residual disease (MRD) negativity rate

    Measured: Up to 5 years

  12. Incidence of adverse events (AEs)

    Measured: Up to 5 years

  13. Incidence of serious adverse events (SAEs)

    Measured: Up to 5 years

  14. Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30)

    Measured: Up to 5 years

  15. Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study start3 May 2024 (estimated)
  3. Primary completion16 Nov 2025 (estimated)
  4. Study completion21 Sep 2030 (estimated)

Why it stopped: Business objectives have changed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06232707
Sponsor's protocol ID
CA058-1019
Other IDs
2023-509472-42, U1111-1281-8227, 2023
Acronym
ALUMMINATE
Status last verified
May 2024
First submitted
22 Jan 2024
Last updated
31 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alnuctamab, Pomalidomide and Daratumumab in people with Multiple Myeloma, run by Celgene at 170 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in China, United States, Japan, Australia, Spain and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06232707.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.

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