Allogeneic stem cell transplantation vs. conventional therapy as salvage therapy for relapsed / progressed patients with multiple myeloma after first-line therapy (AlloRelapseMMStudy)

2024-510590-14-00 Protocol AlloRelapseMMStudy Therapeutic confirmatory (Phase III) Ended

Start 3 Mar 2023 · End 30 Jan 2025 · Status Ended · 1 EU/EEA countries · 30 sites · Protocol AlloRelapseMMStudy

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ended
Participants planned 400
Countries 1
Sites 30

multiple myeloma

The present clinical study aims to demonstrate the superiority of allogeneic stem (alloSCT) cell transplantation compared to conventional therapy for the difference in overall survival (OS) at 5 years in patients with multiple myeloma who have relapsed or progressed after first-line autologous hematopoietic stem cell t…

Key facts

Sponsor
University Medical Center Hamburg-Eppendorf
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
3 Mar 2023 → 30 Jan 2025
Decision date (initial)
2024-09-02
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Gemeinsamer Bundesausschuss (G-BA)

External identifiers

EU CT number
2024-510590-14-00
EudraCT number
2021-001005-67
ClinicalTrials.gov
NCT05675319

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The present clinical study aims to demonstrate the superiority of
allogeneic stem (alloSCT) cell transplantation compared to conventional
therapy for the difference in overall survival (OS) at 5 years in patients
with multiple myeloma who have relapsed or progressed after first-line
autologous hematopoietic stem cell therapy.

Secondary objectives 8

  1. To show an improvement of progression free survival and relapse free survival after alloSCT cell transplantation compared to conventional therapy
  2. quality of life
  3. toxicities
  4. recurrence rates
  5. non-relapse mortality (NRM)
  6. remission rates
  7. incidence of severe or life-threatening infectionas well as minimal residual disease (MRD) between the two arm sare compared
  8. Acute and chronic Graft-versus-Host Disease (GvHD) after allo-SCT are evaluated

Conditions and MedDRA coding

multiple myeloma

VersionLevelCodeTermSystem organ class
21.0 LLT 10028228 Multiple myeloma 10029104

Study design 2 periods

#TitleAllocationBlindingRoles blindedArms
1 Treatment period 1: Salvage Therapy
After eligible patients have been enrolled in the study (enrollment, section 11.1.1), they will receive 3 cycles of salvage therapy with one of the currently approved triplet regimens for first relapse: carfilzomib/ lenalidomide/ dexamethasone (KRD) or daratumumab in combination with either lenalidomide or bortezomib or pomalidomide plus dexamethasone (DRD or DVD or DPD) or ixazomib/lenalidomide plus dexamethasone (IRD) or elotuzumab/ lenalidomide plus dexamethasone (ERD) or pomalidomide/bortezomib/dexamethasone (PVD) or carfilzomib/dexamethasone/daratumumab (KDD) or isatuximab/carfilzomib/dexamethasone (Isa-KD) or selinexor/bortezomib/dexamethasone (SVD) After 3 cycles of salvage therapy, remission status is assessed. Uniform Response Criteria for Multiple Myeloma published by the International Myeloma Working Group (IMWG) will be used, please refer to appendix section 20.1 for details. If the patient has progressive disease (PD) or no suitable donor, he/ she will be withdrawn from the study. If the patient has achieved stable disease (SD) or partial remission (PR) or complete remission (CR) and a compatible stem cell donor (HLA-ident. sibling or 10/10 MUD resp. 9/10 MMUD if mismatch in HLA-DQB) could be located after 3 cycles of salvage therapy, he/she will be randomized to the conventional (Arm B) or allogeneic (Arm A) study arm. If a donor is found, a 4th and max. 5th cycle of salvage therapy can be performed until SCT is scheduled. In these cases, remission status after the 4th or 5th cycle has to be confirmed.
 2 None Salvage Therapy: Patients receive a currently approved triplet therapies for first relapse:
Carfilzomib/ lenalidomide/ dexamethasone (KRD)
Elotuzumab/ lenalidomide/ dexamethasone (ERD)
Daratumumab/ bortezomib/ dexamethasone (DVD)
Daratumumab/ lenalidomide/ dexamethasone (DRD)
Ixazomib/ lenalidomide/ dexamethasone (IRD)
Pomalidomide/ bortezomib/ dexamethasone (PVD)
Carfilzomib/ daratumumab/ dexamethasone (KDD)
Daratumumab/pomalidomide/dexamethasone (DPD)
Isatuximab/carfilzomib/dexamethasone (Isa-KD)
Selinexor/bortezomib/dexamethasone (SVD)
2 Treatment period 2
After Salvage Therapie > Randomization >
 Randomised Controlled None Allogenic Stem Cell Transplantation: Allogenic Stem Cell Transplantation and Maintance therapy with lenalidomide for up to max. 2 years
Conventional Therapy: Continuation of salvage therapy up to progress or Autologous Stem cell transplantation with melphalan 200 mg/m²

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

  1. Patients eligible for study inclusion/enrollment must meet criteria 1-7 and all of the criteria (1-9) before randomization
  2. 1) Multiple Myeloma
  3. 2) Age 18 - 65 years
  4. 3) A signed informed consent form must be obtained before participation in the study
  5. 4) Age 66 - 70 years, if comorbidity index according to Sorror score = 0 and ECOG ≤ 1
  6. 5) 1st relapse/ progression according to IMWG criteria after first-line therapy (consisting of induction therapy followed by autologous transplantation once or twice and maintenance therapy) Additionally: meeting the need for treatment based on the SLiM-CRAB-criteria
  7. 6) Negative pregnancy test in female patients
  8. 7) Maximum of 1 cycle salvage therapy prior to study inclusion/enrollment
  9. 8) Availability of a fully compatible stem cell donor (HLA-ident. sibling or 10/10 MUD or 9/10 MMUD if mismatch affects DQB) after 3 cycles salvage therapy
  10. 9) CR/ PR or SD according to IMWG criteria after 3 cycles salvage therapy within the study

Exclusion criteria 8

  1. Patients are not included in the study if any one of criteria 1-6 are met and if criterion 7 is met before randomization:
  2. 1. Non-sufficient organ function defined as:  Bilirubin (in the absence of Meulengracht's disease), SGPT or SGOT ≥ 3 times higher than normal values  Cardiac ejection fraction ≤ 50 %  GFR < 30 ml/min  DLCO < 35 % or continuous oxygen dependency
  3. 2. Active hepatitis B or C infection or uncontrolled HIV infection
  4. 3. Other, active malignant disease
  5. 4. Prior treatment with allogeneic stem cells
  6. 5. Participation in a clinical trial or taking an IMP within 30 days or five times the half-life of the IMP, whichever is longer, prior to study inclusion/enrollment
  7. 6. Positive serum pregnancy test at screening and before first treatment or breastfeeding
  8. 7. Progressive disease (PD) on salvage therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Overall survival (OS) at five years after randomization (Patient observed from randomization until database lock for final analysis and overall survival rate calculated at 5 years after randomization)

Secondary endpoints 19

  1. Event-free survival (EFS) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and EFS rate calculated at 1 year after randomization). Event defined as:  Progression (according to IMWG criteria) or  Relapse (according to IMWG criteria) or  Engraftment Failure (defined as no stable neutrophil count > 0.5 x 109/l on day 28 after SCT, see 11.2.12) or  Death of any cause
  2. Event-free survival at 3 years after randomization (Patient observed from randomization until database lock for final analysis and EFS rate calculated at 3 years after randomization) Event defined as:  Progression (according to IMWG criteria) or  Relapse (according to IMWG criteria) or  Engraftment Failure (defined as no stable neutrophil count > 0.5 x 109/l on day 28 after SCT, see 11.2.12) or  Death of any cause
  3. Event-free survival at 5 years after randomization (Patient observed from randomization until database lock for final analysis and EFS rate calculated at 5 years after randomization) Event defined as:  Progression (according to IMWG criteria) or  Relapse (according to IMWG criteria) or  Engraftment Failure (defined as no stable neutrophil count > 0.5 x 109/l on day 28 after SCT, see 11.2.12) or  Death of any cause
  4. Change from baseline in total EORTC score at 1 year after randomization (Patient observed from baseline until database lock for final analysis and adjusted mean calculated at 1 year after randomization)
  5. Change from baseline in total EORTC score at 3 years after randomization (Patient observed from baseline until database lock for final analysis and adjusted mean calculated at 3 years after randomization)
  6. Change from baseline in total EORTC score at 5 years after randomization (Patient observed from baseline until database lock for final analysis and adjusted mean calculated at 5 years after randomization)
  7. Time to first occurrence of remission (partial or complete) after randomization (Patient is followed from randomization until database lock for final analysis and cumulative incidence of first remission, at 2 years after randomization, is reported)
  8. Non-relapse mortality (NRM) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 1 year after randomization reported)
  9. Non-relapse mortality (NRM) at 3 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 3 years after randomization reported)
  10. Non-relapse mortality (NRM) at 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 5 years after randomization reported)
  11. Cumulative incidence of acute graft-versus-host disease (GvHD) after allogeneic stem cell transplantation (according to Przepiorka et al.[1]) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD at 1year after randomization reported)
  12. Cumulative incidence of acute GvHD after allogeneic stem cell transplantation (according to Przepiorka et al.[1]) at 3 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD at 3 years after randomization reported
  13. Cumulative incidence of acute GvHD after allogeneic stem cell transplantation (according to Przepiorka et al. [1]) at 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD at 5 years after randomization reported)
  14. Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation (according to Jagasia et al.[2]) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD at 1 year after randomization reported)
  15. Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation (according to Jagasia et al. [2]) at 3 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD at 3 years after randomization reported)
  16. Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation (according to Jagasia et al. [2]) at 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD at 5 years after randomization reported)
  17. Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 1 year after randomization (patient observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 1 year after randomization reported).
  18. Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 3 years after randomization (patient observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 3 years after randomization reported).
  19. Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 5 years after randomization (patient observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 5 years after randomization reported).

Investigational products

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

Test 4

Revlimid 10 mg hard capsules

PRD9264292 · Product

Active substance
Lenalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
25 mg milligram(s)
Max total dose
14531 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L04AX04 — -
Marketing authorisation
EU/1/07/391/010
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Revlimid 10 mg hard capsules

PRD9264283 · Product

Active substance
Lenalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
25 mg milligram(s)
Max total dose
14531 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L04AX04 — -
Marketing authorisation
EU/1/07/391/002
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Revlimid 5 mg hard capsules

PRD9264284 · Product

Active substance
Lenalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
25 mg/g milligram(s)/gram
Max total dose
14531 mg/l milligram(s)/litre
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L04AX04 — -
Marketing authorisation
EU/1/07/391/001
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Revlimid 5 mg hard capsules

PRD9264287 · Product

Active substance
Lenalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
25 mg milligram(s)
Max total dose
14531 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L04AX04 — -
Marketing authorisation
EU/1/07/391/008
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 36

NINLARO 4 mg hard capsules

PRD4535103 · Product

Active substance
Ixazomib Citrate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
4 mg milligram(s)
Max total dose
110040 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01XX50 — -
Marketing authorisation
EU/1/16/1094/003
MA holder
TAKEDA PHARMA A/S
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/11/899
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
1.3 mg/m2 milligram(s)/sq. meter
Max total dose
192 mg/m2 milligram(s)/sq. meter
Max treatment duration
1965 Day(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

Fortecortin® Inject 4 mg Injektionslösung in einer Ampulle

PRD11062952 · Product

Active substance
Dexamethasone Dihydrogen Phosphate Disodium Ph. Eur.
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
40 mg milligram(s)
Max total dose
11810 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
9739.00.00
MA holder
MERCK HEALTHCARE GERMANY GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fortecortin® 4 mg Tabletten

PRD10475523 · Product

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
40 mg milligram(s)
Max total dose
11810 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
23764.00.00
MA holder
MERCK HEALTHCARE GERMANY GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8132765 · Product

Active substance
Isatuximab
Substance synonyms
Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
10 mg/Kg milligram(s)/kilogram
Max total dose
580 mg/kg milligram(s)/kilogram
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01FC02 — -
Marketing authorisation
EU/1/20/1435/001
MA holder
SANOFI WINTHROP INDUSTRIE
MA country
EU
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
SUBCUTANEOUS INJECTION
Max daily dose
1800 mg milligram(s)
Max total dose
46800 mg milligram(s)
Max treatment duration
1965 Day(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
Yes
Orphan designation number
EU/3/18/2020
Modified vs. Marketing Authorisation
No

NINLARO 2.3 mg hard capsules

PRD4535101 · Product

Active substance
Ixazomib Citrate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
4 mg milligram(s)
Max total dose
332 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01XX50 — -
Marketing authorisation
EU/1/16/1094/001
MA holder
TAKEDA PHARMA A/S
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/11/899
Modified vs. Marketing Authorisation
No

NINLARO 3 mg hard capsules

PRD4535133 · Product

Active substance
Ixazomib Citrate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
4 mg milligram(s)
Max total dose
332 mg milligram(s)
Max treatment duration
1965 Week(s)
Authorisation status
Authorised
ATC code
L01XX50 — -
Marketing authorisation
EU/1/16/1094/002
MA holder
TAKEDA PHARMA A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/11/899
Modified vs. Marketing Authorisation
No

Empliciti 300 mg powder for concentrate for solution for infusion.

PRD4073295 · Product

Active substance
Elotuzumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg milligram(s)
Max total dose
24000 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01XC23 — -
Marketing authorisation
EU/1/16/1088/001
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/12/1037
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
4 mg milligram(s)
Max total dose
2067 mg milligram(s)
Max treatment duration
1965 Day(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 2 mg hard capsules

PRD9260810 · Product

Active substance
Pomalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
4 mg milligram(s)
Max total dose
2067 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L04AX06 — -
Marketing authorisation
EU/1/13/850/006
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

DARZALEX 20 mg/mL concentrate for solution for infusion

PRD4091129 · Product

Active substance
Daratumumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
20 mg/kg milligram(s)/kilogram
Max total dose
520 mg/kg milligram(s)/kilogram
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01FC01 — -
Marketing authorisation
EU/1/16/1101/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/18/2020
Modified vs. Marketing Authorisation
No

Kyprolis 10 mg powder for solution for infusion

PRD4519870 · Product

Active substance
Carfilzomib
Substance synonyms
PR-171
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
56 mg/m2 milligram(s)/square meter
Max total dose
110040 mg/m2 milligram(s)/square meter
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01XG02 — -
Marketing authorisation
EU/1/15/1060/002
MA holder
AMGEN EUROPE B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/08/548
Modified vs. Marketing Authorisation
No

DARZALEX 20 mg/mL concentrate for solution for infusion

PRD4091122 · Product

Active substance
Daratumumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
20 mg/kg milligram(s)/kilogram
Max total dose
520 mg/kg milligram(s)/kilogram
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01FC01 — -
Marketing authorisation
EU/1/16/1101/002
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/18/2020
Modified vs. Marketing Authorisation
No

DARZALEX 20 mg/mL concentrate for solution for infusion

PRD6808129 · Product

Active substance
Daratumumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
20 mg/kg milligram(s)/kilogram
Max total dose
520 mg/kg milligram(s)/kilogram
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01FC01 — -
Marketing authorisation
EU/1/16/1101/003
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/18/2020
Modified vs. Marketing Authorisation
No

Bortezomib medac 3,5 mg Pulver zur Herstellung einer Injektionslösung

PRD6350734 · Product

Active substance
Bortezomib
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
1.3 mg/m2 milligram(s)/sq. meter
Max total dose
192 mg/m2 milligram(s)/sq. meter
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01XG01 — -
Marketing authorisation
2200797.00.00
MA holder
MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fortecortin® Inject 40 mg Injektionslösung in einer Ampulle

PRD10350025 · Product

Active substance
Dexamethasone Dihydrogen Phosphate Disodium Ph. Eur.
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
40 mg milligram(s)
Max total dose
11810 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
486.00.00
MA holder
MERCK HEALTHCARE GERMANY GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fortecortin® 0,5 mg Tabletten

PRD10324451 · Product

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
40 mg milligram(s)
Max total dose
11810 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
9587.00.00
MA holder
MERCK HEALTHCARE GERMANY GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fortecortin® 2 mg Tabletten

PRD10324898 · Product

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
40 mg milligram(s)
Max total dose
11810 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
9587.01.00
MA holder
MERCK HEALTHCARE GERMANY GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fortecortin® 8 mg Tabletten

PRD10247009 · Product

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
40 mg milligram(s)
Max total dose
11810 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
9587.02.00
MA holder
MERCK HEALTHCARE GERMANY GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

NEXPOVIO 20 mg film-coated tablets

PRD9867762 · Product

Active substance
Selinexor
Substance synonyms
KPT-330, (Z)-3-(3-(3,5-BIS(TRIFLUOROMETHYL)PHENYL)-1H-1,2,4-TRIAZOL-1-YL)-N'-(PYRAZIN-2-YL)ACRYLOHYDRAZIDE
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
100 mg milligram(s)
Max total dose
2214 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01XX66 — -
Marketing authorisation
EU/1/21/1537/001
MA holder
STEMLINE THERAPEUTICS B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

NEXPOVIO 20 mg film-coated tablets

PRD9867763 · Product

Active substance
Selinexor
Substance synonyms
KPT-330, (Z)-3-(3-(3,5-BIS(TRIFLUOROMETHYL)PHENYL)-1H-1,2,4-TRIAZOL-1-YL)-N'-(PYRAZIN-2-YL)ACRYLOHYDRAZIDE
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
100 mg milligram(s)
Max total dose
2214 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01XX66 — -
Marketing authorisation
EU/1/21/1537/002
MA holder
STEMLINE THERAPEUTICS B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8132767 · Product

Active substance
Isatuximab
Substance synonyms
Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
10 mg/kg milligram(s)/kilogram
Max total dose
580 mg/kg milligram(s)/kilogram
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01FC02 — -
Marketing authorisation
EU/1/20/1435/003
MA holder
SANOFI WINTHROP INDUSTRIE
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
4 mg milligram(s)
Max total dose
2067 mg milligram(s)
Max treatment duration
1965 Day(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 1 mg hard capsules

PRD9260809 · Product

Active substance
Pomalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
4 mg milligram(s)
Max total dose
2067 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L04AX06 — -
Marketing authorisation
EU/1/13/850/005
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

NEXPOVIO 20 mg film-coated tablets

PRD9867765 · Product

Active substance
Selinexor
Substance synonyms
KPT-330, (Z)-3-(3-(3,5-BIS(TRIFLUOROMETHYL)PHENYL)-1H-1,2,4-TRIAZOL-1-YL)-N'-(PYRAZIN-2-YL)ACRYLOHYDRAZIDE
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
100 mg milligram(s)
Max total dose
2214 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01XX66 — -
Marketing authorisation
EU/1/21/1537/004
MA holder
STEMLINE THERAPEUTICS B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Imnovid 3 mg hard capsules

PRD9260813 · Product

Active substance
Pomalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
4 mg milligram(s)
Max total dose
2067 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L04AX06 — -
Marketing authorisation
EU/1/13/850/007
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

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
INJECTION
Max daily dose
40 mg milligram(s)
Max total dose
11810 mg milligram(s)
Max treatment duration
1965 Day(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

Kyprolis 30 mg powder for solution for infusion

PRD4301210 · Product

Active substance
Carfilzomib
Substance synonyms
PR-171
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
56 mg/m2 milligram(s)/sq. meter
Max total dose
110040 mg/m2 milligram(s)/square meter
Max treatment duration
1965 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
Yes
Orphan designation number
EU/3/08/548
Modified vs. Marketing Authorisation
No

Empliciti 400 mg powder for concentrate for solution for infusion.

PRD4073314 · Product

Active substance
Elotuzumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg milligram(s)
Max total dose
24000 mg milligram(s)
Max treatment duration
1965 Week(s)
Authorisation status
Authorised
ATC code
L01XC23 — -
Marketing authorisation
EU/1/16/1088/002
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/12/1037
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
4 mg milligram(s)
Max total dose
2067 mg milligram(s)
Max treatment duration
1965 Day(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

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8132766 · Product

Active substance
Isatuximab
Substance synonyms
Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
10 mg/kg milligram(s)/kilogram
Max total dose
580 mg/Kg milligram(s)/kilogram
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01FC02 — -
Marketing authorisation
EU/1/20/1435/002
MA holder
SANOFI WINTHROP INDUSTRIE
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
Substance synonyms
PR-171
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
56 mg/m2 milligram(s)/square meter
Max total dose
110040 mg/m2 milligram(s)/square meter
Max treatment duration
1965 Day(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
Yes
Orphan designation number
EU/3/08/548
Modified vs. Marketing Authorisation
No

Fortecortin® Inject 100 mg Injektionslösung in einer Ampulle

PRD10351285 · Product

Active substance
Dexamethasone Dihydrogen Phosphate Disodium Ph. Eur.
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
40 mg milligram(s)
Max total dose
11810 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
486.01.00
MA holder
MERCK HEALTHCARE GERMANY GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

NEXPOVIO 20 mg film-coated tablets

PRD9867764 · Product

Active substance
Selinexor
Substance synonyms
KPT-330, (Z)-3-(3-(3,5-BIS(TRIFLUOROMETHYL)PHENYL)-1H-1,2,4-TRIAZOL-1-YL)-N'-(PYRAZIN-2-YL)ACRYLOHYDRAZIDE
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
100 mg milligram(s)
Max total dose
2214 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01XX66 — -
Marketing authorisation
EU/1/21/1537/003
MA holder
STEMLINE THERAPEUTICS B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

NEXPOVIO 20 mg film-coated tablets

PRD9867766 · Product

Active substance
Selinexor
Substance synonyms
KPT-330, (Z)-3-(3-(3,5-BIS(TRIFLUOROMETHYL)PHENYL)-1H-1,2,4-TRIAZOL-1-YL)-N'-(PYRAZIN-2-YL)ACRYLOHYDRAZIDE
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
100 mg milligram(s)
Max total dose
2214 mg milligram(s)
Max treatment duration
1965 Day(s)
Authorisation status
Authorised
ATC code
L01XX66 — -
Marketing authorisation
EU/1/21/1537/005
MA holder
STEMLINE THERAPEUTICS B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Medical Center Hamburg-Eppendorf

11 Total trials 4 Recruiting 5 Ended
Academic / Non-commercial
Sponsor organisation
University Medical Center Hamburg-Eppendorf
Address
Martinistrasse 52, Eppendorf Eppendorf
City
Hamburg
Postcode
20251
Country
Germany

Scientific contact point

Organisation
University Medical Center Hamburg-Eppendorf
Contact name
Sponsor UKE Hamburg

Public contact point

Organisation
University Medical Center Hamburg-Eppendorf
Contact name
Sponsor UKE Hamburg

Third parties 2

OrganisationCity, countryDuties
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
ORG-100008474
 Mainz, Germany On site monitoring, Code 12, Code 5, Data management, Code 8
Staburo GmbH
ORG-100042826
 Munich, Germany Code 10

Locations

1 EU/EEA country · 30 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ended 400 30
Rest of world — 0 —

Investigational sites

Germany

30 sites · Ended
University Medical Center Hamburg-Eppendorf
Zentrum für Onkologie Interdisziplinäre Klinik für Stammzelltransplantation, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Heidelberg AöR
Zentrum für Innere Medizin Innere Medizin V, Hämatologie/Onkologie/Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik und Poliklinik I Bereich Hämatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Muenster AöR
Medizinische Klinik A, KMT-Zentrum, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Innere Medizin II Sektion für Stammzell- und Immuntherapie, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Regensburg AöR
Klinik und Poliklinik für Innere Medizin II, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitätsklinikum Düsseldorf
Klinik für Hämatologie, Onkologie und Klinische Immunologie, Moorenstr. 5, 40225, Düsseldorf
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin II Hämatologie und Internistische Onkologie, Am Klinikum 1, Lobeda, Jena
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
III. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Halle (Saale) AöR
Innere Medizin IV (Hämatologie und Onkologie), Ernst-Grube-Strasse 30, Kroellwitz, Halle (Saale)
Universitaetsklinikum Tuebingen AöR
Abteilung Innere Medizin II, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Universitaetsklinikum Essen AöR
Klinik für Hämatologie und Stammzelltransplantation, Hufelandstrasse 55, Holsterhausen, Essen
Medical Center - University Of Freiburg
Klinik für Innere Medizin I, Hämatologie, Onkologie und Stammzelltransplantation, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Augsburg
Innere Medizin Schwerpunkt Hämatologie und Onkologie, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaetsmedizin Goettingen
Klinik für Hämatologie und Medizinische Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Aachen AöR
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV), Pauwelsstrasse 30, 52074, Aachen
HELIOS Klinikum Berlin-Buch GmbH
Klinikum für Hämatologie und Stammzelltransplantation, Schwanebecker Chaussee 50, Buch, Berlin
Klinikum Nuernberg
Klinik für Innere Medizin 5, Schwerpunkt Onkologie/ Hämatologie, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Klinikum rechts der Isar der TU Muenchen AöR
Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie, Ismaninger Strasse 22, Au-Haidhausen, Munich
Robert Bosch Krankenhaus GmbH
Abteilung für Hämatologie, Onkologie und Palliativmedizi, Auerbachstrasse 110, Bad Cannstatt, Stuttgart
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin III, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Bonn AöR
Medizinische Klinik III, Venusberg-Campus 1, Venusberg, Bonn
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III, Flemmingstrasse 2, Altendorf, Chemnitz
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Frankfurt AöR
Medizinische Klinik II, Hämatologie und Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Asklepios Klinik St George
Hämatologie, Onkologie und Stammzelltransplantation, Lohmuehlenstrasse 5, St. Georg, Hamburg
Klinikum Oldenburg AöR
Universitätsklinik für Innere Medizin – Onkologie und Hämatologie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg
Universitaetsklinikum Giessen und Marburg GmbH
Klinik für Hämatologie, Onkologie und Immunologie, Baldingerstrasse 1, 35043, Marburg

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2023-03-03 2023-03-03 2024-12-20

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

TitleSubmission dateStatusType
Summary_of_Resluts_AlloRelapseMM
SUM-116745
 2026-01-28T13:04:12 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
AlloRelapse Layperson Summary of Results_DE 2026-01-28T13:05:14 Submitted Laypersons Summary of Results

Documents 51 files

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

TypeTitleVersion
Laypersons summary of results (for publication) AlloRelapse Layperson Summary of Results_DE 1
Protocol (for publication) D1_Protocol_2024_510590_14_00 5.0
Protocol (for publication) D4_Patient facing documents_questionnaire EORTC QLQ-C30 3.0
Protocol (for publication) D4_Patient facing documents_questionnaire EORTC QLQ-MY20 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Schwangere Studienteilnehmerin_V3_1_2024_04_02 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Schwangerschaft Partnerin_V3_1_2024_04_02 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Spender_V3_0_2024_01_30 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Studienteilnehmer_V4_1_2024_04_02 4.1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Bortezomib Injektionslosung_2021-11 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Darzalex Infusionslosung_2024_10 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Darzalex Injektionslosung_02_2024 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Empliciti Infusionslosung_2023-06 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Fortecortin Inject_2022-02 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Imnovid Hartkapseln_2023-08 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Kyprolis Infusionslosung_2023-12 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Nexpovio Filmtabletten_2024-01 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Ninlaro Hartkapseln_2024-08 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Revlimid Hartkapseln 2023-09 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Sarclisa Infusionslosung_2024_04 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Velcade Injektionslosung_Mai 2024 1.0
Summary of Product Characteristics (SmPC) (for publication) E2-SmPC_Fortecortin Tabletten_2023-07 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder SMPC 1
Summary of results (for publication) Summary_of_Resluts_AlloRelapseMM 1
Synopsis of the protocol (for publication) D1_Protocol synopsis DE_2024_510590_14_00 5.0

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-08-16 Germany Acceptable with conditions
2024-08-26
 2024-09-02
2 SUBSTANTIAL MODIFICATION SM-1 2024-12-17 Germany Acceptable
2025-02-05
 2025-02-05

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