Clinical Trials Register

Summary
EudraCT Number:	2013-005485-19
Sponsor's Protocol Code Number:	BPV
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-07-18
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2013-005485-19

A.3

Full title of the trial

Bendamustine, Prednisone and Velcade® for first-line treatment of patients with symptomatic multiple myeloma not eligible for high-dose chemotherapy followed by autologous stem cell transplantation (BPV).

Bendamustine, Prednisone und Velcade® als Erstlinienbehandlung von Patienten mit symptomatischem Multiplen Myelom, die nicht für eine Hochdosis Chemotherapie und anschließender Stammzelltransplantation geeignet sind (BPV)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Combination of Bendamustine, Bortezomib and Velcade as preferred treatment of patients with newly diagnosed multiple myeloma not eligible for high dose chemotherapy followed by stem cell transplantation

Kombination von Bendamustine, Prednisone und Velcade® als bevorzugte Behandlung von Patienten mit symptomatischem Multiplen Myelom, die nicht für eine Hochdosis Chemotherapie und anschließender Stammzelltransplantation geeignet sind

A.3.2

Name or abbreviated title of the trial where available

BPV

A.4.1

Sponsor's protocol code number

BPV

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Ruprecht-Karls-University Heidelberg, Med Faculty represented by University Clinic HD and its Comm. Director
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Mundipharma GmbH
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	Janssen-Cilag GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Coordination Centre for Clinical Trials (KKS)
B.5.2	Functional name of contact point	Baerbel Schurich
B.5.3	Address:
B.5.3.1	Street Address	Marsilius-Arkaden-Turm West, Im Neuenheimer Feld 130.3
B.5.3.2	Town/ city	Heidelberg
B.5.3.3	Post code	69120
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49622156 34512
B.5.5	Fax number	+49622156 33508
B.5.6	E-mail	baerbel.schurich@med.uni-heidelberg.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Levact
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Bendamustine
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BENDAMUSTINE HYDROCHLORIDE
D.3.9.1	CAS number	3543-75-7
D.3.9.4	EV Substance Code	SUB00696MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	25 to 100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Cytostatic drug
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Velcade
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN-CILAG INTERNATIONAL NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Bortezomib
D.3.4	Pharmaceutical form	Powder for concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BORTEZOMIB
D.3.9.1	CAS number	179324-69-7
D.3.9.4	EV Substance Code	SUB20020
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Cytostatic drug
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Prednisone
D.3.9.3	Other descriptive name	PREDNISONE
D.3.9.4	EV Substance Code	SUB10020MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5 to 50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Glucocorticoid

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

multiple myeloma (symptomatic, newly diagnosed) not eligible for high dose chemotherapy and subsequent stem cell transplantaion

symptomatisches Multiples Myelom, Neudiagnose, nicht geeignet für Hochdosischemotherapie und anschließender Stammzelltransplantation

E.1.1.1

Medical condition in easily understood language

newly diagnosed multiple Myeloma not eligible for high dose chemotherapy and stem cell transplantation

neu diagnostiziertes Multiples Myelom, Patient für Hochdosistherapie und anschließende Stammzelltransplantation nicht geeignet.

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10028228
E.1.2	Term	Multiple myeloma
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main purpose of the study is to demonstrate the efficacy of BPV to efficiently decrease myeloma tumour burden.

Nachweis der therapeutischen Wirksamkeit von PBV bezüglich erfolgreicher Verringerung der Tumorlast

E.2.2

Secondary objectives of the trial

- Number and percentage of patients achieving a complete response (CR)
-Progression-free survival (PFS)
-Overall survival (OS)
-Time-to-progression (TTP)
-Disease-free survival (DFS)
-Duration of response (DOR)
- Renal response according Criteria for the Definition of Renal Response to Antimyeloma Therapy (IMWG), (CRrenal, PRrenal, MRrenal),
-Toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)

-Zahl und % Patienten, die ein komplettes Ansprechen erreichen (CR)
-Progressionsfreies Überleben (PFS)
-Gesamtüberleben (OS)
-Zeit bis zum Progress (TTP)
-Krankheitsfreies Überleben (DFS)
-Dauer des Ansprechens (DOR)
-Ansprechen bezüglich der Niereninsuffizienz entsprechend den IMWG Kritierien (CRrenal, PRrenal, MRrenal)
-Toxizität (unerwünschte Ereignisse ab CTC Grad 3 und schwerwiegende unerwünschte Ereignisse)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Newly diagnosed multiple myeloma requiring systemic treatment (according to CRAB criteria as specified in the appendix) with following characteristics: Subject is not a candidate for high-dose chemotherapy and stem cell transplantation due to age, presence of comorbidities likely to have a negative impact on tolerability of HDT-SCT, or subject preference
2. Measurable disease, defined as any quantifiable monoclonal protein value, defined by at
least one of the following three measurements (International Working Group , 2003 and Durie et al, 2006) (see appendix II)
a. Serum M-protein ≥ 10g/l
b. Urine light-chain (M-protein) of ≥ 200 mg/24 hours
c. Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal
3. Age ≥18 years
4. WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions) 5. For women of childbearing potential: negative pregnancy test at inclusion
6. All men and women of childbearing potential must be willing and capable to use highly effective contraception during the complete therapy. [CPMP/ICH/286/95 mod: Highly effective
methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e.,less than 1% per year) when used consistently and correctly. Examples of Highly effective and additional
methods:- Intrauterine device (IUD), Hormonal (birth control pills, injections, implants), Tubal ligation,Partner’s vasectomy. Additional effective methods: Male condom, Diaphragm, Cervical Cap]
7. All patients must agree to abstain from donating blood while on study
8. Ability to understand character and individual consequences of the clinical trial
9. Written informed consent (must be available before enrolment in the trial)

1. Neu diagnostiziertes behandlungsbedürftiges Multiples Myelom (CRAB Kriterien, Appendix I) wenn folgende Kriterien zutreffen: Der Patient ist altersbedingt oder aufgrund von Begleiterkrankungen nicht für eine Hochdosistherapie mit anschließender Stammzelltransplantation (HDT-SCT) geeignet, oder der Patient wünscht keine HDT-SCT)
2. Messbare Erkrankung durch quantifizierbares monoklonales Protein, definiert durch mindestens einen der folgenden Befunde:
a) Serum M-protein ≥ 10g/l
b) Urin Leichtkette (M-protein) of ≥ 200 mg/24 Stunden
c) Serum FLC Assay: betroffener FLC Wert ≥ 10 mg/dl vorausgesetzt der sFLC ratio ist abnormal.
3. Alter≥18 Jahre
4. WHO Performance Status 0-3 (WHO=3 ist nur erlaubt wenn -bedingt durch Multiples Myeloma und nicht durch Begleiterkrankung verursacht)
5. Frauen in gebärfähigem Alter müssen vor Studienbeginn einen negativen Schwanger-schaftstest vorweisen.
6. Alle Patienten müssen willens und fähig sein eine adäquate Schwangerschaftsverhütung während der gesamten Studienlaufzeit zu gewährleisten.
7. Alle Patienten müssen zustimmen während der Studienlaufzeit kein Blut zu spenden.
8. Der Patient muss fähig sein das Wesen und die individuellen Konsequenzen der Studie zu verstehen.
9. Eine unterschriebene Einwilligungserklärung muss vor Studienbeginn vorliegen.

E.4

Principal exclusion criteria

Subjects presenting any of the following criteria will not be included in the trial:
1. Patient has known hypersensitivity to bortezomib, bendamustine, prednisone or to any of the constituent compounds (incl. boron and mannitol).
2. Systemic AL amyloidosis (except for patients with AL amyloidosis of the skin or the bone marrow)
3. Previous chemotherapy or radiotherapy during the past 5 years except patient’s local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 3 weeks prior to study entry.)
4. Plasma cell leukaemia which requires the presence of 20% of plasma cell in peripheral blood leukocytes and at least 2/nl.
5. Severe cardiac dysfunction (NYHA classification III-IV)
6. Significant hepatic dysfunction (serum bilirubin ≥ 2 mg/dl or ASAT and/or ALAT ≥ 2.5 times normal level), unless related to myeloma
7. Patients known to be HIV-positive
8. Patients with active, uncontrolled infections
9. Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0)
10. Second malignancy within the past 5 years except:
a. Adequately treated basal cell or squamous cell skin cancer,
b. Carcinoma in situ of the cervix, or
c. Prostate cancer < Gleason score 6 with undetectable prostate-specific antigen (PSA) over 12 months, or
d. Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins), or
e. Similar condition with an expectation of > 95 % 5-year disease free survival
11. Patients with acute diffuse infiltrative pulmonary and pericardial disease
12. Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
13. Platelet count < 50 x 109/l (transfusion support within 14 days before the test is not allowed), unless related to myeloma
14. Hemoglobin < 7.5g/dl, unless related to myeloma
15. Absolute neutrophil count (ANC) < 0.75 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed), unless related to myeloma
16. Pregnancy and lactation
17. Participation in other clinical trials within one month prior to enrolment except patients for supportive care studies and vaccination studies. (Note: This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months).

1. bekannte Überempfindlichkeit gegen Bortezomib, Bendamustin, Prednison oder einen der Inhaltsstoffe (incl. Bor und Mannitol).
2. Systemische AL Amyloidose (mit Ausnahme von Patienten mit AL Amyloidose der Haut oder des Knochenmarks)
3. Chemotherapie oder Radiotherapie während der letzten 5 Jahre mit Ausnahme lokaler Radiotherapie im Fall lokaler Myelom Progression. (Cave: Patienten können eine kumulative Dosis bis zu 160 mg Dexamethason oder Äquivalent als Notfalltherapie innerhalb drei Wochen vor Studienbeginn erhalten)
4. Plasmazell-Leukämie mit einem Plasmazellgehalt von 20% in den peripheren Blut Leukozyten und mindestens 2 Plasmazellen/nl.
5. Schwere kardiale Störung (NYHA Klassifikation III-IV)
6. Signifikante hepatische Störung (Serum Bilirubin ≥ 2 mg/dl oder ASAT und/oder ALAT ≥ 2.5 mal Normwert), außer myelombedingt.
7. Patienten mit bekannter HIV-Positivität
8. Patienten mit aktiver unkontrollierter Infektion
9. Patienten mit peripherer Neuropathie oder neuropatischem Schmerz von CTC Grad 2 oder höher (definiert in den NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0)
10. Zweit-Malignom während der letzten 5 Jahre mit Ausnahme von:
a. Adäquat behandeltes Basalzell- oder Plattenepithel Karzinom der Haut, oder
b. Carcinoma in situ der Zervix, oder
c. Prostata-Karzinom < Gleason score 6 mit nicht nachweisbarem PSA-Wert über einen Zeitraum von 12 Monaten, oder
d. Ductales Brust Karzinom in situ nach kompletter chirurgischer Entfernung und R0-Resektion, oder
e. Eine vergleichbare maligne Erkrankung wie a.- d. bei der zu 95% eine mind. 5 jährige Krankheitsfreiheit angenommen werden kann.
11. Patienten mit akuten diffusen Infiltraten in Lunge und Perikard
12. Autoimmunbedingte hämolytische Anämie mit positivem Coombstest oder Thrombozytopenie
13. Thrombozytenzahl < 50 x 109/l (keine Transfusion innerhalb 14 Tage vor dem Test erlaubt), Ausnahme myelombedingt
14. Hämoglobin < 7.5g/dl, Ausnahme myelombedingt
15. Absolute Neutrophilen Zahl (ANC) < 0.75 x 109/l (der Einsatz von “colony stimulating factors” innerhalb von 14 Tagen vor der Untersuchung ist nicht erlaubt), Ausnahme myelombedingt
16. Schwangerschaft und Stillen
17. Teilnahme an anderen klinischen Studien innerhalb eines Monats vor Einschluss, mit Ausnahme von Begleittherapie-Studien und Impfstudien (gilt nicht für Langzeit-Follow Up Perioden ohne Behandlung mit aktiven Substanzen während der letzten 6 Monate)

E.5 End points

E.5.1

Primary end point(s)

Overall Response Rate (ORR) of BPV, ORR is defined as PR or better.

Gesamtansprechrate (ORR) nach BPV (definiert als partielle Remission PR oder besser)

E.5.1.1

Timepoint(s) of evaluation of this end point

Response evaluation after 3, 6 and 9 cycles BPV treatment, after premature treatment termination and during Follow-up everry 3 months until first progression

nach 3,6,9. Monaten, nach vorzeitigem Behandlungsende und im Follow-up alle 3 Monate (bis zur Progression) Ermittlung des Ansprechens

E.5.2

Secondary end point(s)

-Number and percentage of patients achieving a complete response (CR)
-Progression-free survival (PFS)
-Overall survival (OS)
-Time-to-progression (TTP)
-Disease-free survival (DFS)
-Duration of response (DOR)
- Renal response according Criteria for the Definition of Renal Response to Antimyeloma Therapy (IMWG), (CRrenal, PRrenal, MRrenal),
-Toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)

- Zahl (und %) der Patienten, die ein Komplettes Ansprechen (CR) erreichen
-Progressionsfreies Überleben (PFS)
-Gesamtüberleben (OS)
-Zeit bis zum Progress (TTP)
-Erkrankungsfreies Überleben (DFS)
-Dauer des Ansprechens DOR
- Verbesserung der Nierenfunktion gemäß IMWG (komplette Remission ® renal, partielle remission (PR) renal, minimale remission (MR) renal-
-Toxizität (bzgl. unerwünschter Ereignisse von CTCAE grade ≧3 und SAEs)

E.5.2.1

Timepoint(s) of evaluation of this end point

any time

jederzeit

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

End of trial is defined defined as the last Visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Supportive care as required per local guidelines.
In patients with relapsed myeloma the treatment options depend on the compounds used in prior therapy, the duration of response, performance status, type of relapse, and previous toxicity. The decision about relapse treatment for a patient should be made by the investigator considering these issues. It is recommended that relapse treatment will be performed within a clinical trial.

Weitere Betreuung entsprechend den lokalen Richtlinien.
Bei einem Rückfall der Erkrankung richtet sich die Behandlung nach den früheren Therapien, der Dauer des Ansprechens, des körperlichen Zustandes, der Art des Rückfalls und früheren Toxizitäten. Die Entscheidung über die Therapie bei Rückfall sollte der Behandler treffen, indem er diese Komponenten berücksichtigt. Es wird empfohlen die Behandlung eines Krankheitsrückfalles im Rahmen einer klinischen Studie durchzuführen

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-10-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-10-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-08-01

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IMP with orphan designation in the indication
Orphan Designation Number:
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