Clinical Trials Register

Summary
EudraCT Number:	2012-005683-10
Sponsor's Protocol Code Number:	GEM2012MENOS65
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-07-09
Trial 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

Spain - AEMPS

A.2

EudraCT number

2012-005683-10

A.3

Full title of the trial

Estudio fase III nacional, multicéntrico, abierto, aleatorizado, de tratamiento de inducción con bortezomib/lenalidomida/dexametasona (VRD-GEM), seguido de altas dosis de quimioterapia con melfalán-200 (MEL-200) vs. busulfan-melfalán (BUMEL) y consolidación con VRD-GEM para pacientes con mieloma múltiple sintomático de nuevo diagnóstico menores de 65 años

A National, Multicenter, Open Label, Randomized Phase III study for Induction therapy with BORTEZOMIB/ LENALIDOMIDE/ DEXAMETHASONE (VRD-GEM) followed by High-dose Chemotherapy with MELPHALAN-200 (MEL-200) vs. BUSULFAN/MELPHALAN (BUMEL) and Consolidation therapy with VRD-GEM in symptomatic multiple myeloma Patients newly diagnosed under age 65.

A.3.1

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

A.4.1

Sponsor's protocol code number

GEM2012MENOS65

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	FUNDACIÓN PETHEMA
B.1.3.4	Country	Spain
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	FUNDACIÓN PETHEMA
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Trial Form Support, S.L.
B.5.2	Functional name of contact point	Begoña García
B.5.3	Address:
B.5.3.1	Street Address	Calle Arturo Soria
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28033
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3491 125 05 50
B.5.5	Fax number	+3491 125 05 51
B.5.6	E-mail	begona.garcia@tfscro.com

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	Velcade 3,5mg, viales de polvo liofilizado para reconstituir vía subcutánea.
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN-CILAG INTERNATIONAL N.V
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Velcade
D.3.2	Product code	Velcade
D.3.4	Pharmaceutical form	Concentrate and solvent 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.3.9.3	Other descriptive name	BORTEZOMIB
D.3.9.4	EV Substance Code	SUB20020
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m3 milligram(s)/cubic meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.3
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	No
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	REVLIMID 5mg cápsulas duras
D.2.1.1.2	Name of the Marketing Authorisation holder	CELGENE EUROPE LTD.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	REVLIMID
D.3.2	Product code	REVLIMID
D.3.4	Pharmaceutical form	Capsule, hard
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	LENALIDOMIDE
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
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	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	No
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.2.1.1.1	Trade name	REVLIMID 10 mg cápsulas duras
D.2.1.1.2	Name of the Marketing Authorisation holder	CELGENE EUROPE LTD
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	REVLIMID
D.3.2	Product code	REVLIMID
D.3.4	Pharmaceutical form	Capsule, hard
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	LENALIDOMIDE
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
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	10
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	No
D.IMP: 4
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	REVLIMID 15MG cápsulas duras
D.2.1.1.2	Name of the Marketing Authorisation holder	CELGENE EUROPE LTD
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	REVLIMID
D.3.2	Product code	REVLIMID
D.3.4	Pharmaceutical form	Capsule, hard
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	LENALIDOMIDE
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
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	15
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	No
D.IMP: 5
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	REVLIMID 25mg cápsulas duras
D.2.1.1.2	Name of the Marketing Authorisation holder	CELGENE EUROPE LTD
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	REVLIMID
D.3.2	Product code	REVLIMID
D.3.4	Pharmaceutical form	Capsule, hard
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	LENALIDOMIDE
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
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	25
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	No
D.IMP: 6
D.1.2 and D.1.3	IMP Role	Comparator
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	Not Applicable
D.2.1.1.2	Name of the Marketing Authorisation holder	Not Applicable
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	MELFALÁN
D.3.4	Pharmaceutical form	Suspension and solvent for suspension for injection
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	MELPHALAN
D.3.9.1	CAS number	148-82-3
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	na
D.3.9.4	EV Substance Code	SUB08728MIG
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	2
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	No
D.IMP: 7
D.1.2 and D.1.3	IMP Role	Comparator
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	Dexametasona
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Capsule
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	DEXAMETHASONE
D.3.9.1	CAS number	na
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	na
D.3.9.4	EV Substance Code	SUB07017MIG
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	40
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	No
D.IMP: 8
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	BUSULFÁN
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	BUSULFÁN
D.3.2	Product code	BUSULFÁN
D.3.4	Pharmaceutical form	Concentrate and solvent for solution for injection
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	BUSULFAN
D.3.9.1	CAS number	55-98-1
D.3.9.4	EV Substance Code	SUB05993MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3.2
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	No

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

Mieloma multiple

E.1.1.1

Medical condition in easily understood language

Multiple myeloma

Mieloma multiple

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Progression-free survival after autologous transplantation with BuMel vs. MEL-200 in patients receiving GEM VRD-induction regimen prior.

Supervivencia libre de progresión después de autotrasplante con BUMEL vs. MEL-200 en pacientes que han recibido VRD-GEM como régimen de inducción previo.

E.2.2

Secondary objectives of the trial

Rate of complete remission (CR) with negative immunofixation after each stage of treatment (induction and consolidation autotransplantation).

Evaluation of minimal residual disease (MRD) in patients with negative immunofixation RC-after each stage of treatment (induction and consolidation autotransplantation).

Overall survival (OS) after PBSCT with BuMel vs. MEL-200.

To evaluate the safety and tolerability of induction and consolidation treatment.

Tasa de remisiones completas (RC) con inmunofijación negativa tras cada etapa de tratamiento (inducción, autotrasplante y consolidación).

Evaluación de la enfermedad mínima residual (EMR) en pacientes con RC-inmunofijación negativa tras cada etapa de tratamiento (inducción, autotrasplante y consolidación).

Supervivencia global (SG) tras TASPE con BUMEL vs. MEL-200.

Evaluar la seguridad y tolerabilidad del tratamiento de inducción y consolidación.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

E.3

Principal inclusion criteria

All patients must meet the following inclusion criteria:
The patient must, in the opinion of the investigator, be able to fulfill all the requirements of the assay.
Signed informed consent
Age between 18-65 years and a candidate for the realization of an autologous transplant.
ECOG performance status greater than 2 (or 3 if the ECOG myeloma is due to, eg. Pathologic fracture)
Patients newly diagnosed symptomatic multiple myeloma based on standard criteria (Appendix 6) and has not received any previous chemotherapy treatment for MM.
Patients with measurable disease defined by the following criteria:
For the secretory MM, measurable disease was defined as any measurable value monoclonal protein in serum (IgG greater or equal 10 g / L or higher IgA or equal to 5 g / L) and / or where applicable, a chain excretion light in urine greater than or equal to 200 mg/24 hours.
For multiple myeloma oligosecretor or secretory measurable disease defined by the presence of soft tissue plasmacytomas (not bone) determined by clinical examination or radiographic methods (eg. MRI, CT-Scan).
Life expectancy greater than 3 months.
The patient must have the following laboratory values ??within 21 days before the start of treatment (day 1, cycle 1):
Platelet count greater than or equal to 100 x 109 / L and absolute neutrophil count greater than or equal to 1.0 x 109 / L
Corrected serum calcium less than 14 mg / dL.
Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 2.5 x the upper limit of normal (ULN).
Total bilirubin within normal limits.
Serum creatinine less than or equal to 2 mg / dL
Women of childbearing potential and men (including those undergoing vasectomy and if your partner is a woman of childbearing potential), must use two forms of contraception throughout treatment, during dose interruptions and for 4 weeks after receiving the last dose, and meet all the requirements of Annex 10.

Todos los pacientes deben cumplir los siguientes criterios de inclusión:
El paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo.
Consentimiento informado firmado
Edad entre 18-65 años y candidato a la realización de un trasplante autólogo.
Estado funcional ECOG mayor a 2 (ó 3 si el ECOG se debe al mieloma, por ej. fractura patológica)
Paciente de nuevo diagnóstico, con mieloma múltiple sintomático basado en los criterios estándar (anexo 6) y que no ha recibido ningún tratamiento previo de quimioterapia para el MM.
Paciente con enfermedad medible, definida por los siguientes criterios:
Para el MM secretor, la enfermedad medible se define como cualquier valor cuantificable de proteína monoclonal en suero (IgG mayor o igual 10 g/L o IgA mayor o igual a 5 g/L) y/o cuando sea aplicable, una excreción de cadena ligera en orina mayor o igual a 200 mg/24 horas.
Para mieloma múltiple oligosecretor o no secretor, la enfermedad medible se define por la presencia de plasmocitomas de tejido blando (no óseo) determinados mediante examen clínico o métodos radiográficos (ej. MRI, CT-Scan).
Esperanza de vida mayor a 3 meses.
El paciente debe tener los siguientes valores de laboratorio en los 21 días previos al inicio del tratamiento (día 1, ciclo 1):
Recuento de plaquetas mayor o igual a 100 x 109/L y recuento absoluto de neutrófilos mayor o igual a 1.0 x 109/L
Calcio sérico corregido menor a 14 mg/dL.
Aspartato transaminasa (AST) y alanina transaminasa (ALT) menor o igual a 2.5 x el límite superior de normalidad (LSN).
Bilirrubina total dentro de los límites de normalidad.
Creatinina sérica menor o igual a 2 mg/dL
Las mujeres con capacidad de gestación y los varones (incluyendo aquellos sometidos a vasectomía y si su pareja es una mujer con capacidad de gestación), deberán utilizar dos métodos anticonceptivos durante todo el tratamiento, durante las interrupciones de dosis y hasta 4 semanas después de recibir la última dosis, así como cumplir todos los requisitos del anexo 10.

E.4

Principal exclusion criteria

Patients with any of the following exclusion criteria may not be included in the clinical trial:
Non-secretory myeloma without measurable plasmacytomas.
Patient who has previously received treatment for multiple myeloma, with the exception of pulse steroids, bisphosphonates or radiotherapy for some emergency treatment before induction.
Peripheral neuropathy greater than or equal to grade 2 within 21 days prior to inclusion.
Hypersensitivity to bortezomib, boric acid, mannitol or lenalidomide.
Patients who have received any investigational agent within 28 days prior to inclusion.
Patient who has had a myocardial infarction within 6 months prior to inclusion in the clinical trial or has a functional class III or IV according to the New York Heart Association (NYHA) heart failure, uncontrolled angina, ventricular arrhythmias not controlled or detected electrocardiographically acute ischemia or conduction system disorders.
Patients who are currently in another clinical trial or receiving any investigational agent.
Positive serology for HBV, HCV or HIV.

Los pacientes que presenten alguno de los siguientes criterios de exclusión no podrán ser incluidos en el ensayo clínico:
Mieloma no secretor sin plasmocitomas medibles.
Paciente que haya recibido previamente tratamiento para el mieloma múltiple, con la excepción de pulsos de esteroides, bifosfonatos o radioterapia por alguna urgencia antes de empezar el tratamiento de inducción.
Neuropatía periférica mayor o igual a grado 2 dentro de los 21 días previos a su inclusión.
Hipersensibilidad conocida al bortezomib, ácido bórico, manitol o lenalidomida.
Pacientes que hayan recibido cualquier agente en investigación en los 28 días previos a su inclusión.
Paciente que haya tenido un infarto de miocardio en los 6 meses previos a la inclusión en el ensayo clínico o posea una clase funcional III o IV de acuerdo con la New York Heart Association (NYHA), insuficiencia cardiaca, angina no controlada, arritmias ventriculares no controladas o isquemia aguda detectada electrocardiográficamente o trastornos del sistema de conducción.
Pacientes que estén actualmente en otro ensayo clínico o recibiendo cualquier agente en investigación.
Serología positiva para VHB, VHC o VIH.

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS) after the two packaging schemes

Supervivencia libre de progresión (SLP) tras los dos esquemas de acondicionamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

60 meses

60 months

E.5.2

Secondary end point(s)

Tasa de remisiones completas tras cada etapa de tratamiento (inducción, autotrasplante y consolidación).
Estudios secuenciales de enfermedad mínima residual negativa (EMR) en pacientes en remisión completa tras cada etapa de tratamiento (inducción, autotrasplante y consolidación).
Supervivencia global.
Seguridad de la combinación VRD-GEM en inducción y consolidación y de ambos esquemas de acondicionamiento.

Complete remission rate after each stage of treatment (induction and consolidation autotransplantation).
Studies sequential negative minimal residual disease (MRD) in patients in complete remission after each stage of treatment (induction and consolidation autotransplantation).
Overall survival.
Security VRD-GEM in combination induction and consolidation and preparation of both schemes.

E.5.2.1

Timepoint(s) of evaluation of this end point

60 meses

60 months

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

Yes

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

Yes

E.8.1.7.1

Other trial design description

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.8.3

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

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

LPLV

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

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:

460

F.1.3

Elderly (>=65 years)

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

460

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)

No hay planes de tratamiento para los sujetos una vez finalicen el estudio

There are not plans for treatment or care after the subject has ended the participation in the trial

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

2013-07-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-17

P. End of Trial
P.	End of Trial Status	Completed

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Orphan Designation Number:
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