A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy with Standard-of-Care Combination Regimens in Adult Participants with Relapsed/Refractory Multiple Myeloma (RRMM)

2024-519504-27-00 Protocol R5458-ONC-2246 Therapeutic confirmatory (Phase III) Authorised, recruitment pending

Status Authorised, recruitment pending · 10 EU/EEA countries · 68 sites · Protocol R5458-ONC-2246

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruitment pending
Participants planned 866
Countries 10
Sites 68

Relapsed Refractory Multiple Myeloma

Part 1 - To evaluate the safety and tolerability of condensed step-up dosing for linvoseltamab and linvoseltamab + carfilzomib treatment and select the RP3Rs for Arm A and Arm B in Part 2 Part 2 (dual) - To compare the proportion of participants who achieve MRD-negative CR at 12 months in each linvoseltamab arm (Arm A…

Key facts

Sponsor
Regeneron Pharmaceuticals Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Decision date (initial)
2026-02-16
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Part 1 - To evaluate the safety and tolerability of condensed step-up dosing for linvoseltamab and linvoseltamab + carfilzomib treatment and select the RP3Rs for Arm A and Arm B in Part 2

Part 2 (dual) - To compare the proportion of participants who achieve MRD-negative CR at 12 months in each linvoseltamab arm (Arm A or Arm B) vs standard therapy (Arm C)
Part 2 (dual) - To compare PFS in each linvoseltamab arm (Arm A or Arm B) vs standard therapy (Arm C)

Secondary objectives 14

  1. Part 1 - To assess the occurrence of grade ≥2 CRS when linvoseltamab is initiated using a condensed step-up dosing schedule
  2. Part 2 - To compare OS in each linvoseltamab arm (Arm A or Arm B) vs standard therapy (Arm C)
  3. Part 2 - To evaluate the proportion of participants by treatment arm who achieve a best response according to the following categories: ORR, ≥VGPR, ≥CR
  4. Part 2 - To compare clinical outcomes between treatment arms including: DOR, TTP, TTNT, PFS2
  5. Part 2 - To compare the proportion of participants who achieve MRD-negative CR at any time between treatment arms
  6. Part 2 - To compare time to response between treatment arms
  7. Part 2 - To compare the proportion of participants with sustained MRD negativity between treatment arms
  8. Part 2 - To compare the duration of MRD-negative CR between treatment arms
  9. Part 2 - To assess and compare safety and tolerability between treatment arms
  10. Part 2 - To evaluate the PK of linvoseltamab alone and in combination with carfilzomib
  11. Part 2 - To assess the immunogenicity of linvoseltamab alone and in combination with carfilzomib
  12. Part 2 - To evaluate sBCMA concentrations at baseline and over time
  13. Part 2 - To compare patient-reported HRQoL, physical functioning, role functioning, and symptoms between treatment arms
  14. Part 2 - To assess patient-reported overall impact of treatment toxicity between treatment arms

Conditions and MedDRA coding

Relapsed Refractory Multiple Myeloma

VersionLevelCodeTermSystem organ class
25.0 LLT 10086466 Relapsed/refractory multiple myeloma 100000004848

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody
  2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
  3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy
  4. NOTE: Other protocol defined inclusion criteria apply

Exclusion criteria 5

  1. Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded
  2. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  3. Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
  4. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder
  5. NOTE: Other protocol defined exclusion criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 8

  1. Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs)
  2. Part 1 - Severity of TEAEs
  3. Part 1 - Occurrence of Adverse Events of Special Interest (AESI)
  4. Part 1 - Severity of AESIs
  5. Part 1 - Occurrence of Serious Adverse Events (SAEs)
  6. Part 1 - Severity of SAEs
  7. Part 2 - Minimal Residual Disease (MRD) -negative Complete response (CR)
  8. Part 2 - Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC

Secondary endpoints 36

  1. Part 1 - Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)
  2. Part 1 - Timing of grade ≥2 CRS
  3. Part 2 - Overall Survival (OS)
  4. Part 2 - Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC
  5. Part 2 - Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC
  6. Part 2 - Achievement of CR or better per IMWG response criteria as determined by BIRC
  7. Part 2 - Duration Of Response (DOR) as per IMWG response criteria
  8. Part 2 - Time To Progression (TTP) as per IMWG response criteria
  9. Part 2 - Time To Next Treatment (TTNT)
  10. Part 2 - Second PFS
  11. Part 2 - MRD-negative CR criteria at any time
  12. Part 2 - Time to PR IMWG response category
  13. Part 2 - Time to VGPR IMWG response category
  14. Part 2 - Time to CR IMWG response category
  15. Part 2 - Time to stringent Complete Response (sCR) IMWG response category
  16. Part 2 - Sustained of MRD-negative CR
  17. Part 2 - Duration of MRD-negative CR
  18. Part2 - Occurrence of TEAEs
  19. Part 2 - Severity of TEAEs
  20. Part 2 - Occurrence of AESIs
  21. Part 2 - Severity of AESIs
  22. Part 2 - Occurrence of SAEs
  23. Part 2 - Severity of SAEs
  24. Part 2 - Concentrations of linvoseltamab in serum over time
  25. Part 2 - Incidence of Antidrug Antibodies (ADAs) to linvoseltamab
  26. Part 2 - Magnitude of ADAs to linvoseltamab
  27. Part 2 - Concentrations total soluble B-cell Maturation Antigen (sBCMA) in serum over time
  28. Part 2 - Change from baseline in Global Health Status (GHS)/Quality of Life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-C30)
  29. Part 2 - Change from baseline in Physical Functioning (PF), per EORTC QLQ-C30
  30. Part 2 - Change from baseline in Role Functioning (RF), per EORTC QLQ-C30
  31. Part 2 - Change from baseline in pain, per EORTC QLQ-C30
  32. Part 2 - Change from baseline in fatigue, per EORTC QLQ-C30
  33. Part 2 - Change in patient reported Disease Symptoms (DS) per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20])
  34. Part 2 - Change in patient reported Treatment Side Effects (TSE) per EORTC QLQ-MY20
  35. Part 2 - Change in patient-reported health state per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) Visual Analogue Scale (VAS)
  36. Part 2 - Change in patient-reported overall impact of treatment per Functional Assessment of Chronic Illness Therapy (FACIT) item GP5

Investigational products

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

Test 5

LYNOZYFIC 5 mg concentrate for solution for infusion

PRD12371732 · Product

Active substance
Linvoseltamab
Substance synonyms
REGN5458
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
NOTASSIGN — -
Marketing authorisation
EU/1/25/1917/001
MA holder
REGENERON IRELAND D.A.C.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

LYNOZYFIC 200 mg concentrate for solution for infusion

PRD12371736 · Product

Active substance
Linvoseltamab
Substance synonyms
REGN5458
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
NOTASSIGN — -
Marketing authorisation
EU/1/25/1917/002
MA holder
REGENERON IRELAND D.A.C.
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
INTRAVENOUS INFUSION
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 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

Kyprolis 10 mg powder for solution for infusion

PRD4301209 · Product

Active substance
Carfilzomib
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
L01XG02 — -
Marketing authorisation
EU/1/15/1060/002
MA holder
AMGEN EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kyprolis 30 mg powder for solution for infusion

PRD4301210 · Product

Active substance
Carfilzomib
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
L01XG02 — -
Marketing authorisation
EU/1/15/1060/003
MA holder
AMGEN EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 8

DARZALEX 1800 mg solution for injection

PRD8157846 · Product

Active substance
Daratumumab
Substance synonyms
HuMax-CD38
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 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

VELCADE 3.5 mg powder for solution for injection

PRD3349073 · Product

Active substance
Bortezomib
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS INJECTION
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
L01XG01 — -
Marketing authorisation
EU/1/04/274/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethasone Medochemie 8 mg/2 ml süste-/infusioonilahus

PRD10987866 · Product

Active substance
Dexamethasone Phosphate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0 mg/ml milligram(s)/millilitre
Max total dose
0 mg/ml milligram(s)/millilitre
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
1104623
MA holder
MEDOCHEMIE LTD.
MA country
Estonia
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
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Imnovid 4 mg hard capsules

PRD9260808 · Product

Active substance
Pomalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 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 2 mg hard capsules

PRD9260805 · Product

Active substance
Pomalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 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 1 mg hard capsules

PRD9260804 · Product

Active substance
Pomalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 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

Imnovid 3 mg hard capsules

PRD9260806 · Product

Active substance
Pomalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 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

Auxiliary 8

Dexamethasonfosfaat Accord 4 mg/ml oplossing voor injectie/infusie

PRD11709106 · Product

Active substance
Dexamethasone Phosphate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0 mg/ml milligram(s)/millilitre
Max total dose
0 mg/ml milligram(s)/millilitre
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
RVG 129844
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethasone

SUB07017MIG · Substance

Active substance
Dexamethasone
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paracetamol 10 mg/ mL solution for infusion

PRD1184080 · Product

Active substance
Paracetamol
Substance synonyms
ACETAMINOPHEN
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
00 mg/ml milligram(s)/millilitre
Max total dose
00 mg/ml milligram(s)/millilitre
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
N02BE01 — PARACETAMOL
Marketing authorisation
PL 24598/0028
MA holder
NORIDEM ENTERPRISES LTD
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paracetamol 1000mg Tablets

PRD11648176 · Product

Active substance
Paracetamol
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
N02BE01 — PARACETAMOL
Marketing authorisation
PL 20416/0423
MA holder
CRESCENT PHARMA INTERNATIONAL LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Aciclovir 200 mg Tablets

PRD7232211 · Product

Active substance
Aciclovir
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
J05AB01 — ACICLOVIR
Marketing authorisation
PL 16363/0556
MA holder
MILPHARM LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dermodrin 30 mg/2 ml soluție injectabilă

PRD9054487 · Product

Active substance
Diphenhydramine Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
00 mg/ml milligram(s)/millilitre
Max total dose
00 mg/ml milligram(s)/millilitre
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
R06AA02 — DIPHENHYDRAMINE
Marketing authorisation
13919/2021/01
MA holder
PHARMAZEUTISCHE FABRIK MONTAVIT GES.M.B.H.
MA country
Romania
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Diphenhydramine Hydrochloride Tablets 25 mg

PRD1176427 · Product

Active substance
Diphenhydramine Hydrochloride
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
R06AA — AMINOALKYL ETHERS
Marketing authorisation
PL 20416/0067
MA holder
CRESCENT PHARMA LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Co-Trimoxazole 80/400mg Tablets

PRD10021767 · Product

Active substance
Sulfamethoxazole
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Authorised
ATC code
J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
Marketing authorisation
PL 11311/0352
MA holder
TILLOMED LABORATORIES LTD
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Regeneron Pharmaceuticals Inc.

71 Total trials 25 Recruiting 32 Ended
Commercial
Sponsor organisation
Regeneron Pharmaceuticals Inc.
Address
777 Old Saw Mill River Road
City
Tarrytown
Postcode
10591-6717
Country
United States

Scientific contact point

Organisation
Regeneron Pharmaceuticals Inc.
Contact name
Medical Affairs

Public contact point

Organisation
Regeneron Pharmaceuticals Inc.
Contact name
Medical Affairs

Third parties 14

OrganisationCity, countryDuties
Clariness GmbH
ORG-100045306
 Hamburg, Germany Other
Yprime LLC
ORG-100042888
 Malvern, United States Other
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland Code 5
Medidata Solutions Inc.
ORG-100016256
 New York, United States Code 5
Millmount Healthcare Limited
ORG-100011724
 Stamullen, Ireland Other
Adaptive Biotechnologies Corp.
ORG-100044428
 Seattle, United States Other
WCG Clinical Inc.
ORG-100040730
 Cary, United States Other
PRA Hellas CRO A.E.
ORG-100048208
 Nea Ionia, Greece Other
Cytel Inc.
ORG-100042560
 Cambridge, United States Other
Yprime LLC
ORG-100042888
 Malvern, United States Interactive response technologies (IRT)
Q Squared Solutions Limited
ORG-100042527
 Reading, United Kingdom Other
Perceptive Informatics Inc.
ORG-100013171
 Burlington, United States Other
Iqvia Rds Inc.
ORG-100043858
 Durham, United States Data management
Transperfect Translations International Inc.
ORG-100043494
 New York, United States Other

Locations

10 EU/EEA countries · 68 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Authorised, recruitment pending 10 5
Belgium Authorised, recruitment pending 28 6
Czechia Authorised, recruitment pending 12 4
France Authorised, recruitment pending 47 11
Germany Authorised, recruitment pending 28 8
Greece Authorised, recruitment pending 41 6
Italy Authorised, recruitment pending 75 12
Netherlands Authorised, recruitment pending 12 4
Poland Authorised, recruitment pending 42 7
Spain Authorised, recruitment pending 20 5
Rest of world
Chile, Korea, Republic of, Argentina, Japan, Australia, Taiwan, United Kingdom, Turkey, Canada, United States, Brazil
 — 551 —

Investigational sites

Austria

5 sites · Authorised, recruitment pending
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Hematology, Heinrich-Collin-Strasse 30, Penzing, Vienna
Klinikum Wels-Grieskirchen GmbH
Oncology, Grieskirchner Strasse 42, 4600, Wels
Johannes Kepler University Linz
Med Campus 3 - Hematology and Oncology, Med Campus III, Krankenhausstrasse 9, Linz
Noe LGA Gesundheit Region Mitte GmbH
Internal Medicine 1, Dunant-Platz 1, 3100, St. Poelten
Medizinische Universitaet Innsbruck
Hematology and Oncology, Anichstrasse 35, 6020, Innsbruck

Belgium

6 sites · Authorised, recruitment pending
CHC MontLegia
Hemato Oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Az St-Jan Brugge-Oostende A.V.
Hematology, Ruddershove 10, 8000, Brugge
UZ Brussel
Hematology, Laarbeeklaan 101, 1090, Jette
Ziekenhuis Oost Limburg
Hematology, Synaps Park 1, 3600, Genk
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Ziekenhuis Aan De Stroom
Hematology, Lindendreef 1, 2020, Antwerp

Czechia

4 sites · Authorised, recruitment pending
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Kralovske Vinohrady
Hematologická klinika, Srobarova 1150/50, Vinohrady, Prague
Fakultni Nemocnice Hradec Kralove
IV. interní hematologická klinika, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Fakultni Nemocnice Brno
Interní hematologická a onkologická klinika, Jihlavska 340/20, Bohunice, Brno

France

11 sites · Authorised, recruitment pending
Centre Hospitalier Victor Dupouy
Hematology Department, 69 Rue Du Lieutenant Colonel Prudhon, 95107, Argenteuil Cedex
Centre Hospitalier Universitaire De Toulouse
Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Leon Berard
Service of Medical Oncology, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire De Poitiers
Hematology and Cellular Therapy Department, 2 Rue De La Miletrie, 86000, Poitiers
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospices Civils De Lyon
Hematology Department, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Metropole Savoie
Hematology Department, Place Lucien Biset, Bp 31125, Chambery
Centre Hospitalier Regional Universitaire De Tours
Hematology and cell therapy, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Nantes
Hematology Department, 1 Place Alexis Ricordeau, 44000, Nantes
CHRU De Nancy
Hematology Department, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Assistance Publique Hopitaux De Paris
Adult Hematology Department, 149 Rue De Sevres, 75015, Paris

Germany

8 sites · Authorised, recruitment pending
Universitaetsklinikum Schleswig-Holstein AöR
Clinic of Hematology and Oncology, Ratzeburger Allee 160, 23538, Luebeck
Gemeinschaftspraxis Haematologie Onkologie
Internal Medicine and Hematology and Oncology, Arnoldstrasse 18, Johannstadt-Nord, Dresden
University Medical Center Hamburg-Eppendorf
Internal Medicine and Hematology and Oncology, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Wuerzburg AöR
Department of Hematology and Oncology, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Internal Medicine and Hematology and Oncology, Langenbeckstrasse 1, Oberstadt, Mainz
Technische Universitaet Dresden
Internal Medicine and Hematology and Oncology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Regensburg AöR
Multiples Myelom, Palliativmedizin, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
Internal Medicine and Hematology, Wetzgauer Strasse 85, 73557, Mutlangen

Greece

6 sites · Authorised, recruitment pending
University General Hospital Of Alexandroupoli
Hematology Department, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Evangelismos S.A.
Hematology and Lymphoma Clinc – Bone Marrow Transplantation Unit, Ipsiladou 45-47, 106 76, Athens
Olympion Therapeftirio General Clinic Of Patras S.A.
Hematology and Oncology Department, Volou & Meilichou, Kato Sychaina, Patra
University General Hospital Of Ioannina
Department of Hematology, Niarchou Stavrou Avenue, 455 00, Ioannina
General Hospital Of Athens Alexandra
Department of Clinical Therapeutics, National & Kapodistrian University of Athens, Vassilissis Sofias Avenue 80, 115 28, Athens
Theageneio Cancer Hospital
Hematology and Oncology Department, Simeonidi Alex 2, 546 39, Thessaloniki

Italy

12 sites · Authorised, recruitment pending
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
UO Ematologia con Trapianto, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Hematology, Corso Bramante 88, 10126, Turin
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Hematology, Via Piero Maroncelli 40, 47014, Meldola
Azienda Unita Sanitaria Locale Della Romagna
Onco-hematology, Viale Vincenzo Randi 5, 48121, Ravenna
Fondazione IRCCS Policlinico San Matteo
SC Ematologia 1, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliera Universitaria Federico II Di Napoli
Uoc Ematologia e Trapianto di midoll, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
U.O.C. Ematologia eCentro Trapianti di Cellule Staminali Emopoietiche, Largo Citta' D'ippocrate 1, 84131, Salerno
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Hematology, Viale Luigi Borri N 57, 21100, Varese
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
SC Hematology, Via Pio II 3, 20153, Milan
Casa Sollievo Della Sofferenza
UOC Ematologia e Trapianto di Cellule Staminali Emopoietiche, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Day Hospital Oncologico, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Uoc Ematologia, Piazzale Spedali Civili 1, 25123, Brescia

Netherlands

4 sites · Authorised, recruitment pending
Radboud universitair medisch centrum Stichting
Hematology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Amphia Hospital
Internal medicine – oncology hematology, Molengracht 21, 4818 CK, Breda
Spaarne Gasthuis Stichting
Hematology, Spaarnepoort 1, 2134 TM, Hoofddorp
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematology, Dr. Molewaterplein 40, 3015 GD, Rotterdam

Poland

7 sites · Authorised, recruitment pending
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hematoonkologii i Chorób Wewnętrznych z Pododdziałem Chemioterapii Dziennej, Ul. Pabianicka 62, 93-513, Lodz
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Oddział Hematologiczny, Ul. Alfreda Sokolowskiego 4, 58-309, Walbrzych
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii, Transplantologii i Terapii Komórkowych, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Oddział Wieloprofilowy Zachowawczy, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Ukladu Chlonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice

Spain

5 sites · Authorised, recruitment pending
Hospital Universitario Dr Peset Aleixandre
Hematology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital Universitario Quironsalud Madrid
Hematology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitari Mutua Terrassa
Hematology, Plaza del Dr. Robert 5, 08221, Terrassa
Hospital General Universitario Dr. Balmis
Hematology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitario De Cabuenes
Hematology, Calle Prados 395, Cabuenes, Gijon

Results and documents

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

Documents 86 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol_2024-519504-27-00_EL_Redacted 1
Protocol (for publication) D1_Protocol_2024-519504-27-00_Redacted EU-1
Protocol (for publication) D4_Patient facing documents eCOA Screen Report_AT_DE 1
Protocol (for publication) D4_Patient facing documents eCOA Screen Report_BE_NL 1
Protocol (for publication) D4_Patient facing documents eCOA Screen Report_CZ 1
Protocol (for publication) D4_Patient facing documents eCOA Screen Report_DE 1
Protocol (for publication) D4_Patient facing documents eCOA Screen Report_EL 1
Protocol (for publication) D4_Patient facing documents eCOA Screen Report_EN_redacted 1
Protocol (for publication) D4_Patient facing documents eCOA Screen Report_ES 1
Protocol (for publication) D4_Patient facing documents eCOA Screen Report_FR 1
Protocol (for publication) D4_Patient facing documents eCOA Screen Report_IT 1
Recruitment arrangements (for publication) K1_AT_Recruitment Procedure_redacted 1.0
Recruitment arrangements (for publication) K1_BE_Recruitment Procedure 1.0
Recruitment arrangements (for publication) K1_CZ_Recruitment Procedure_Bilingual 1.0
Recruitment arrangements (for publication) K1_DE_Recruitment Procedure_redacted 1.0
Recruitment arrangements (for publication) K1_EL_Recruitment Procedure_redacted 1.0
Recruitment arrangements (for publication) K1_ES_Recruitment Procedure 1.0
Recruitment arrangements (for publication) K1_FR_Recruitment Material_Statement N/A
Recruitment arrangements (for publication) K1_FR_Recruitment Procedure_Bilingual 1.0
Recruitment arrangements (for publication) K1_IT_Recruitment Procedure_redacted 2.0
Recruitment arrangements (for publication) K1_NL_Recruitment Procedure 1.0
Recruitment arrangements (for publication) K1_PL_Recruitment Procedure_Polish N/A
Recruitment arrangements (for publication) K2_FR_Recruitment Material_additional document_French_redacted N/A
Recruitment arrangements (for publication) K2_IT_Recruitment Material_Statement N/A
Subject information and informed consent form (for publication) L1_AT_SIS-ICF_Clincierge Data Protection_German 1.0
Subject information and informed consent form (for publication) L1_AT_SIS-ICF_Future Biomedic Research_German 1.0
Subject information and informed consent form (for publication) L1_AT_SIS-ICF_Main_German_redacted 2.0
Subject information and informed consent form (for publication) L1_AT_SIS-ICF_Pregnant Partner_German 2.0
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Clincierge Data Protection_Dutch 1.0
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Clincierge Data Protection_French 1.0
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Main Sponsor Statement 1.0
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Main_Dutch_redacted 3.0
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Main_French_redacted 3.0
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Pregnant Partner_Dutch 2.0
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Pregnant Partner_French 2.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Clincierge Data Protection Notice_Czech 2.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Data Privacy_Czech 1.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Future Biomedical Research_Czech 1.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Main_Czech_redacted 1.1
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Partner Pregnancy_Czech 1.0
Subject information and informed consent form (for publication) L1_DE_SIS-ICF_Clincierge Data Protection_German 1.0
Subject information and informed consent form (for publication) L1_DE_SIS-ICF_FBR_German 1.0
Subject information and informed consent form (for publication) L1_DE_SIS-ICF_Main_German_redacted 1.0
Subject information and informed consent form (for publication) L1_DE_SIS-ICF_Pregnant Partner_German 1.0
Subject information and informed consent form (for publication) L1_EL_SIS-ICF_Clincierge Data Protection Form_Greek 1-0
Subject information and informed consent form (for publication) L1_EL_SIS-ICF_Future Biological Research_Greek 1-0
Subject information and informed consent form (for publication) L1_EL_SIS-ICF_Main_Greek_redacted 1-0
Subject information and informed consent form (for publication) L1_EL_SIS-ICF_Partner Pregnancy_Greek 1-0
Subject information and informed consent form (for publication) L1_ES_SIS-ICF_Future Research_Spanish 1.0
Subject information and informed consent form (for publication) L1_ES_SIS-ICF_Main_Spanish_redacted 2.0
Subject information and informed consent form (for publication) L1_ES_SIS-ICF_Pregnant Partner_Spanish 2.0
Subject information and informed consent form (for publication) L1_FR_SIS-ICF_Clincierge_PFD_Data Protection Notice_French 3.0
Subject information and informed consent form (for publication) L1_FR_SIS-ICF_FBR_French 1.2
Subject information and informed consent form (for publication) L1_FR_SIS-ICF_Main_French_redacted 1.3
Subject information and informed consent form (for publication) L1_FR_SIS-ICF_Pregnant Partner_French 1.1
Subject information and informed consent form (for publication) L1_IT_SIS-ICF_Data Protection Notice Travel Assistance_Italian 1.0
Subject information and informed consent form (for publication) L1_IT_SIS-ICF_Main_Italian_redacted 1.2
Subject information and informed consent form (for publication) L1_IT_SIS-ICF_Pregnant Partner_Italian 1.1
Subject information and informed consent form (for publication) L1_IT_SIS-ICF_Privacy_Italian 1.2
Subject information and informed consent form (for publication) L1_NL_SIS-ICF_Main_Dutch_redacted 1.2
Subject information and informed consent form (for publication) L1_NL_SIS-ICF_PP_Dutch 1.0
Subject information and informed consent form (for publication) L1_PL_SIS-ICF_Adults_Polish_redacted 1.1
Subject information and informed consent form (for publication) L1_PL_SIS-ICF_FBR_Polish 1.1
Subject information and informed consent form (for publication) L1_PL_SIS-ICF_Pregnant Partner_Polish 1.0
Subject information and informed consent form (for publication) L2_FR_Other Subject Material_Patient emergency card_French 1.0
Subject information and informed consent form (for publication) L2_FR_Other Subject Material_Study Participant Feedback Quest_Copyright Statement N/A
Subject information and informed consent form (for publication) L2_NL_Other Subject Material_Clincierge Data Protection Notice_Dutch 2.0
Subject information and informed consent form (for publication) L2_PL_Other Subject Material_Clincierge Data Protection Notice_Polish 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Bortezomib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Carfilzomib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Daratumumab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Dexamethasone 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Pomalidomide 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_AT_DE_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE_DE_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE_FR_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE_NL_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_CZ_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_EL_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_EN_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_FR_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_IT_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_NL_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_PL_2024-519504-27-00 1
Synopsis of the protocol (for publication) D1_Scientific Synopsis_DE_2024-519504-27-00 Redacted 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-10-03 Spain Acceptable with conditions
2026-02-09
 2026-02-10
2 NON SUBSTANTIAL MODIFICATION NSM-1 2026-04-09 Acceptable with conditions
2026-02-09
 2026-04-09

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