A Phase 3 Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants with Relapsed or Refractory Multiple Myeloma (RRMM)

End 17 May 2024 · Status Ended · 14 EU/EEA countries · 54 sites · Protocol CA058-1019

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ended

Participants planned 466

Countries 14

Sites 54

Relapsed and/or Refractory Multiple Myeloma

The main goal is to see if alnuctamab can help people live longer without their cancer getting worse, compared to standard treatments.

Key facts

Sponsor: Celgene International II S.a.r.l.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: completed 17 May 2024
Decision date (initial): 2024-04-22
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Celgene Corporation

External identifiers

EU CT number: 2023-509472-42-00
WHO UTN: U1111-1281-8227

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Pharmacogenomic, Safety, Efficacy

The main goal is to see if alnuctamab can help people live longer without their
cancer getting worse, compared to standard treatments.

Secondary objectives 1

Other goals include looking at how long participants live, how well the treatment works, how safe it is and how participants feel taking the treatment.

Conditions and MedDRA coding

Relapsed and/or Refractory Multiple Myeloma

Version	Level	Code	Term	System organ class
21.0	LLT	10028228	Multiple myeloma	10029104

Regulatory references

Scientific advice from competent authorities: European Medicines Agency, Food And Drug Administration

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed consent form.
Participant has a documented diagnosis of MM, and must: -Have received at least 1 but not more than 3 prior lines of anti-myeloma therapy. Note: One line can contain a planned sequence of treatments (eg, induction, [with or without] hematopoietic stem cell transplant, [with or without] consolidation, and/or [with or without] maintenance therapy).
Have received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).
Have achieved minimal response or better to at least 1 prior anti-myeloma therapy.
Have documented PD during or after their last anti-myeloma therapy or failure to achieve response.
Participants must have measurable disease (as determined by central laboratory), including at least 1 of the criteria below: - Myeloma (M)-protein quantities ≥ 0.5 g/dL by serum protein electrophoresis. - ≥ 200 mg/24-hour urine collection by urine protein electrophoresis. - Serum free light chain levels > 100 mg/L involved light chain and an abnormal kappa/lambda (κ/λ) ratio in participants without detectable serum or urine M-protein.

Exclusion criteria 4

Participant with known current, or history of, central nervous system involvement of multiple myeloma. Evaluation of the cerebrospinal fluid and imaging is only required if central nervous system (CNS) involvement is clinically suspected during the screening process by the investigator.
Participant is not eligible for any SOC regimen on the control arm.
Participant has received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
Participant has never achieved at least stable disease response to prior T-cell redirection therapy (TCE or chimeric antigen receptor T cell [CAR-T])

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

The main thing the researchers are looking at is called "progression-free survival" (“PFS”). This means the time from when a person starts the treatment to when their cancer gets worse, or they die from any cause

Secondary endpoints 4

They will also look at how long people live overall, which is called “overall survival” ("OS").
The researchers will also look at other things to see how well the treatment works. These include how well the cancer responds to the treatment, how long the cancer responds, and how long it takes for people to start a new treatment.
They will also look at any side effects people have while taking the treatment and how it affects their quality of life.
Overall, the researchers want to see if alnuctamab is a safe and effective treatment for people with multiple myeloma.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Alnuctamab

PRD10742225 · Product

Active substance: Alnuctamab
Substance synonyms: EM-901, CC-93269, BMS-986349
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Not Authorised
MA holder: CELGENE CORPORATION
Paediatric formulation: No
Orphan designation: No

Alnuctamab

PRD10742224 · Product

Active substance: Alnuctamab
Substance synonyms: EM-901, CC-93269, BMS-986349
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Not Authorised
MA holder: CELGENE CORPORATION
Paediatric formulation: No
Orphan designation: No

Comparator 9

Fortecortin® Inject 8 mg Injektionslösung in einer Ampulle

PRD10334695 · Product

Active substance: Dexamethasone Dihydrogen Phosphate Disodium Ph. Eur.
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SOLUTION FOR INFUSION
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: H02AB02 — DEXAMETHASONE
Marketing authorisation: 9739.01.00
MA holder: MERCK HEALTHCARE GERMANY GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Empliciti 400 mg powder for concentrate for solution for infusion.

PRD4073310 · Product

Active substance: Elotuzumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: SOLUTION FOR INFUSION
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01XC23 — -
Marketing authorisation: EU/1/16/1088/002
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Kyprolis 60 mg powder for solution for infusion

PRD3374183 · Product

Active substance: Carfilzomib
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: SOLUTION FOR INFUSION
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01XG02 — -
Marketing authorisation: EU/1/15/1060/001
MA holder: AMGEN EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

DARZALEX 1800 mg solution for injection

PRD8157846 · Product

Active substance: Daratumumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SOLUTION FOR INJECTION
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01FC01 — -
Marketing authorisation: EU/1/16/1101/004
MA holder: JANSSEN-CILAG INTERNATIONAL NV
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imnovid 2 mg hard capsules

PRD9260805 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/002
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imnovid 4 mg hard capsules

PRD9260808 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/004
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imnovid 3 mg hard capsules

PRD9260806 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/003
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imnovid 1 mg hard capsules

PRD9260804 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/001
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celgene International II S.a.r.l.

Sponsor organisation: Celgene International II S.a.r.l.
Address: Route De Perreux 1
City: Boudry
Postcode: 2017
Country: Switzerland

Scientific contact point

Organisation: Celgene International II S.a.r.l.
Contact name: GSM-CT

Public contact point

Organisation: Celgene International II S.a.r.l.
Contact name: GSM-CT

Third parties 14

Organisation	City, country	Duties
Accenture Solutions Private Limited ORG-100032592	Bangaluru, India	Other, Data management
Labcorp Central Laboratory Services S.a.r.l. ORG-100011524	Meyrin, Switzerland	Other
National Genetics Institute ORG-100039148	Los Angeles, United States	Other
Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd. ORG-100043119	Shanghai, China	Other
Accenture Solutions Private Limited ORG-100032592	Chennai, India	Data management
Endpoint Clinical Inc. ORG-100040567	Wakefield, United States	Other
Hematogenix ORG-100047219	Cyberjaya, Malaysia	Other
Hematogenix Laboratory Services LLC ORG-100040020	Tinley Park, United States	Other
Labcorp Central Laboratory Services LP ORG-100032236	Indianapolis, United States	Other
Perceptive Informatics Inc. ORG-100013171	Billerica, United States	Other
Pharmaceutical Product Development LLC ORG-100016999	Richmond, United States	Other
Accenture Solutions Private Limited ORG-100032592	Chennai, India	Other
Hematogenix Laboratory Services Limited ORG-100047188	Cheadle, United Kingdom	Other
Signant Health Global LLC ORG-100040604	Blue Bell, United States	Other

Locations

14 EU/EEA countries · 54 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Ended	12	4
Belgium	Ended	17	4
Czechia	Ended	12	3
France	Ended	15	6
Germany	Ended	16	5
Greece	Ended	6	2
Hungary	Ended	10	4
Ireland	Ended	12	4
Italy	Ended	7	4
Norway	Ended	10	3
Portugal	Ended	9	3
Romania	Ended	18	3
Spain	Ended	22	7
Sweden	Ended	11	2
Rest of world Korea, Republic of, Argentina, Turkey, Chile, Switzerland, United States, Canada, Australia, India, China, Brazil, Japan, United Kingdom	—	289	—

Investigational sites

Austria

4 sites · Ended

Noe LGA Gesundheit Region Mitte GmbH

Division of Internal Medicine I, Dunant-Platz 1, 3100, St. Poelten

Medical University Of Vienna

Department of Internal Medicine I, Divison of Haematology and Haemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna

Medizinische Universitaet Innsbruck

University Hospital for Internal Medicine V (Haematology and Oncology), Anichstrasse 35, 6020, Innsbruck

SCRI CCCIT Ges.m.b.H.

Department of Internal Medicine III, Muellner Hauptstrasse 48, 5020, Salzburg

Belgium

4 sites · Ended

UZ Leuven

Haematology, Herestraat 49, 3000, Leuven

CHR Verviers

Onco-hematology, Rue Du Parc 29, 4800, Verviers

Algemeen Ziekenhuis Klina

Haematology, Augustijnslei 100, 2930, Brasschaat

UCL Mont-Godinne

Haematology, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir

Czechia

3 sites · Ended

University Hospital Olomouc

Hemato-onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc

Fakultni Nemocnice Brno

Interni hematologicka a onkologicka klinika, Jihlavska 340/20, Bohunice, Brno

Vseobecna Fakultni Nemocnice V Praze

I. interni klinika - klinika hematologie, U Nemocnice 499/2, Nove Mesto, Prague

France

6 sites · Ended

CHRU De Nancy

Service d'hématologie et Médecine interne, Rue Du Morvan, 54500, Vandoeuvre Les Nancy

Hopital Saint Eloi

Département d'hématologie Clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5

Centre Hospitalier Universitaire De Nantes

Service d'Hématologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes

Centre Hospitalier Universitaire De Lille

Service maladie du sang, Rue Michel Polonovski, 59037, Lille Cedex

Hospices Civils De Lyon

Service d'hématologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite

Centre Hospitalier Universitaire De Toulouse

Service d'hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9

Germany

5 sites · Ended

Technische Universitat Dresden

Medizinische Klinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden

Asklepios Kliniken Hamburg GmbH

Abteilung für Hämatologie, internistische Onkologie, Paliativ-Medizin und Rheumatologie, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg

Universitaet Leipzig

Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig

Universitaetsklinikum Tuebingen AöR

Innere Medizin II - Hämatologie, Onkologie, klinische Immunologie und Rheumatologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen

Universitaetsklinikum Heidelberg AöR

Zentrum für Innere Medizin, Im Neuenheimer Feld 410, Neuenheim, Heidelberg

Greece

2 sites · Ended

University General Hospital Attikon

2nd Propaedeutic Department of Internal Medicine, Rimini Street 1, 124 62, Athens

Alexandra Hospital

Plasma Cell Dyscrasias Unit Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens

Hungary

4 sites · Ended

Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet

Department of Hematology and Stem Cell Transplantation, Albert Florian Ut 5-7, 1097, Budapest IX

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz

Department of Hematology, Markusovszky Str. 5, 9700, Szombathely

Semmelweis University

Department of Internal Medicine and Haematology, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz

Department of Hematology, Szent Istvan Utca 68, 4400, Nyiregyhaza

Ireland

4 sites · Ended

Cork University Hospital

Haematology, Wilton, T12 DC4A, Cork

St Vincent's University Hospital

Haematology, Nutley Lane Donnybrook, Elm Park, Dublin 4

University Hospital Limerick

Cancer Services, Saint Nessan's Road, V94 F858, Limerick

St James's Hospital

Haematology, James's Street, D08 NHY1, Dublin 8

Italy

4 sites · Ended

Azienda Socio Sanitaria Territoriale Ovest Milanese

Oncology, Via Papa Giovanni Paolo II, 20025, Legnano

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Oncology, Via Del Vespro 129, 90127, Palermo

ASST Grande Ospedale Metropolitano Niguarda

Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

Oncology, Via Piero Maroncelli 40, 47014, Meldola

Norway

3 sites · Ended

Oslo University Hospital HF

Oslo Myeloma Center, Taarnbygget, Kirkeveien 166, Oslo

Helse Bergen HF

Dep. of Medicine, Div. of Hematology, Jonas Lies Vei 65, 5021, Bergen

Akershus University Hospital

Department of Haematology, Sykehusveien 25, 1474, Loerenskog

Portugal

3 sites · Ended

Hospital Da Luz S.A.

Serviço Hematologia, Avenida Lusiada 100, 1500-650, Lisbon

Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.

Serviço Hematologia, Rua Professor Lima Basto, 1099-023, Lisbon

Centro Hospitalar Universitario De Lisboa Norte E.P.E.

Serviço de Hematologia, Avenida Professor Egas Moniz, 1649-035, Lisbon

Romania

3 sites · Ended

Spitalul Universitar De Urgenta Bucuresti

Clinica de Hematologie, Splaiul Independentei 169, 050098, Bucharest

Institutul Clinic Fundeni

Clinica de Hematologie si Transplant Medular, Soseaua Fundeni 258, 022328, Bucharest

Onco Card S.R.L.

Sectia Hematologie, Strada Carierei 65 A, 500052, Brasov

Spain

7 sites · Ended

Hospital Universitario Y Politecnico La Fe

Hematology and Hemotherapy, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Clinica Universidad De Navarra

Hematology, Avenue Pio XII 36, 31008, Pamplona

Complexo Hospitalario Universitario De Santiago

Hematology, Calle Choupana Da S/n, 15706, Santiago De Compostela

Hospital Universitario De Salamanca

Hematology, Paseo De San Vicente 58-182, 37007, Salamanca

Hospital De Jerez De La Frontera

Hematology, Carretera De La Ronda Circunvalacion S/n, 11408, Jerez De La Frontera

University Clinical Hospital Virgen De La Arrixaca

Hematology, Carretera De Cartagena Sn, El Palmar, Murcia

Hospital Germans Trias I Pujol

InstitutoCatalán de Oncología de Badalona, Oncology and/or Hematology, Carretera Canyet 1a Planta, 08916, Badalona

Sweden

2 sites · Ended

Sodra Alvsborg Hospital-Vastra Gotalandsregionen

SÄS, Medicinkliniken/Hematolog dagvård, Brämhultsvägen 53, 501 82 Borås, Bramhultsvagen 53, Boras Gustav Adolf, Boras

Sahlgrenska University Hospital-Vastra Gotalandsregionen

Department of hematology and coagulation, Bruna stråket 5, plan 5 413 45 Göteborg, Bla Straket 5, 413 46, Goteborg

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Title	Submission date	Status	Type
2023-509472-42-00_Trial Results Statement SUM-58971	2024-11-22T12:06:34	Submitted	Summary of Results

Documents 1 file

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Summary of results (for publication)	2023-509472-42-00_Trial Results Statement	N/A

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-12-07	Sweden	Acceptable with conditions 2024-04-15	2024-04-16
2	SUBSEQUENT ADDITION OF MSC	APP-2	2024-04-23		Acceptable with conditions 2024-04-15	2024-04-23

A Phase 3 Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants with Relapsed or Refractory Multiple Myeloma (RRMM)

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 1

Conditions and MedDRA coding

Regulatory references

Eligibility criteria

Inclusion criteria 6

Exclusion criteria 4

Endpoints

Primary endpoints 1

Secondary endpoints 4

Investigational products

Test 2

Comparator 9

Sponsors and contacts

Celgene International II S.a.r.l.

Scientific contact point

Public contact point

Third parties 14

Locations

By country

Investigational sites

Results and documents

Summary of results Art. 37(4) CTR

Documents 1 file

Application history

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