Clinical Trials Register

Summary
EudraCT Number:	2014-003282-19
Sponsor's Protocol Code Number:	CA204-125
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-17
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2014-003282-19

A.3

Full title of the trial

An Open Label, Randomized Phase 2 Trial of
Pomalidomide/Dexamethasone With or Without Elotuzumab in relapsed and refractory Multiple Myeloma.

Studio di fase 2, in aperto, randomizzato di pomalidomide/desametasone con o senza elotuzumab nel mieloma multiplo recidivato e refrattario

A.3.1

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

Pomalidomide/Dexamethasone With or Without Elotuzumab in Multiple Myeloma that is resistant to treatment.

Pomalidomide/desametasone con o senza elotuzumab nel mieloma multiplo recidivato e refrattario

A.3.2

Name or abbreviated title of the trial where available

....

.....

A.4.1

Sponsor's protocol code number

CA204-125

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1161-6574

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	BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	GSM-CT
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.4	Telephone number	0000000000000
B.5.5	Fax number	0000000000000000
B.5.6	E-mail	clinical.trials@bms.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	No
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	Elotuzumab
D.3.2	Product code	[BMS-901608]
D.3.4	Pharmaceutical form	Powder 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	ELOTUZUMAB
D.3.9.2	Current sponsor code	BMS-901608
D.3.9.4	EV Substance Code	SUB127980
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	400
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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	No
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	Elotuzumab
D.3.2	Product code	[BMS-901608]
D.3.4	Pharmaceutical form	Powder 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	Elotuzumab
D.3.9.2	Current sponsor code	BMS-901608
D.3.9.3	Other descriptive name	HuLuc63
D.3.9.4	EV Substance Code	SUB127980
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	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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	Empliciti
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
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	Elotuzumab
D.3.2	Product code	[BMS-901608]
D.3.4	Pharmaceutical form	Powder 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	Elotuzumab
D.3.9.2	Current sponsor code	BMS-901608
D.3.9.3	Other descriptive name	Elotuzumab, HuLuc63
D.3.9.4	EV Substance Code	SUB127980
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	400
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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

relapsed and refractory Multiple Myeloma

Mieloma multiplo Recidivo o Refrattario

E.1.1.1

Medical condition in easily understood language

Multiple Myeloma

Mieloma multiplo

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
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

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare progression free survival (PFS) between treatment arms

Confrontare la sopravvivenza libera da malattia (PFS) tra i bracci di trattamento

E.2.2

Secondary objectives of the trial

- To compare objective response rate between treatment arms
- To compare overall survival between treatment arms

- Confrontare il tasso di risposta obiettivo fra i bracci di trattamento - Confrontare la sopravvivenza complessiva fra i bracci di trattamento

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

(1) > = 2 prior lines of therapy which must have included at least 2
consecutive cycles of lenalidomide and a proteosome inhibitor alone or
in combination.
(2) Documented refractory or relapsed and refractory multiple myeloma
(3) Refractory to proteosome inhibitor and lenalidomide, and to their
last treatment
(4) Relapsed and refractory patients had achieved at least a partial
response to previous treatment with proteosome inhibitor or
lenalidomide, or both, but progressed within 6 months, and were
refractory to their last treatment.
(5) Measurable disease at screening
(6) Eastern Cooperative Oncology Group (ECOG) performance status < = 2

(1) = maggiore 2 linee di trattamento precedenti che devono includere almeno 2 cicli consecutivi di lenalidomide ed un inibitore proteosomico da soli o in conbinazione
(2) mieloma multiplo redicidivo o refrattario documentato
(3) refrattarietà a lenalidomide e inibitore proteosomico, e all’ultimo trattamento
(4) pazienti recidivi o refrattari che abbiano ottenuto almeno una risposta parziale ai trattamenti precedenti con lenalidomide e inibitore proteosomico, o entrambi, ma in progressione negli ultimi 6 mesi, e che siano risultati refrattari al loro ultimo trattamento
(5) malattia misurabile allo screening
(6) Eastern Cooperative Oncology Group (ECOG) performance status minore = 2

E.4

Principal exclusion criteria

(1) Active plasma cell leukemia
(2) Prior treatment with pomalidomide
(3) Unable to tolerate thromboembolic prophylaxis while on the study
(4) Prior autologous stem cell transplant within 12 weeks
(5) Known Human Immunodeficiency Virus (HIV) infection or active
hepatitis A, B, or C

(1) leucemia plasma cellule attiva
(2) trattamento precedente con pomalidomide
(3) incapacità di tollerare profilassi tromboembolica nel corso dello studio
(4) precedente trapianto autologo di staminali nelle ultime 12 settimane
(5) infezione da Virus da Immunodeficienza acquisita (HIV) nota o epatiti A, B, C attive

E.5 End points

E.5.1

Primary end point(s)

Progression Free Survival (PFS)

Sopravvivenza libera da malattia (PFS)

E.5.1.1

Timepoint(s) of evaluation of this end point

PFS will be defined as the time, in months, from randomization to the
date of the firstdocumented tumor progression or death due to any
cause.Time Frame: Every 4 weeks relative to the first dose of study
medication, until progressive disease.

La PFS sarà definita come il tempo, in mesi, dalla randomizzazione alla data della prima progressione di malattia documentata o decesso dovuto a qualunque causa. Finestra temporale: ogni 4 settimane dalla prima dose del farmaco sperimentale, fino a progressione

E.5.2

Secondary end point(s)

(1) Objective Response Rate (ORR) is defined as the proportion of randomized subjects who achieve a best response of partial response (PR) or better.(2) Overall Survival (OS) defined as the period of time from randomization until the date of death or last known alive date.

1) determinare il tasso di risposta obiettiva (OOR), definita come la proporzione fra soggetti randomizzati che hanno ottenuto una miglior risposta rispetto a tutti i soggetti randomizzati che hanno ottenuto risposta parziale (PR) o superiore
(2) determinare la Sopravvivenza Globale (OS) definita come il periodo di tempo fra la randomizzazione alla data di decesso o all’ultima data nota di paziente in vita

E.5.2.1

Timepoint(s) of evaluation of this end point

(1) ORR - All response endpoints will be assessed every 4 weeks after the start of study therapy, and until progressive disease occurs.
(2) OS will be assessed every 12 weeks, or more frequently, in the Follow Up Phase of the trial.

(1) ORR – tutti gli endopoints di risposta saranno misurati ogni 4 settimane dopo l’inizio della terapia di studio, e fino a progressione di malattia (2) la OS sarà misurata ogni 12 settimane, o più frequentemente, nella Fase di Follow Up dello studio

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

Yes

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

Yes

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

Yes

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)

Yes

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

Japan

United States

France

Germany

Greece

Italy

Netherlands

Spain

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

LVLS

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

150

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)

Subjects who continue to demonstrate clinical benefit will be eligible to receive study drug via an extension of the study, a rollover study, or
through another mechanism. BMS reserves the right to terminate access to study drug if any of the following occur:
- the MA is rejected by responsible HA
- the study is terminated due to safety concerns
- the subject can obtain medication from a gvt sponsored or private health program
- therapeutic alternatives become available in the local market

Subjects who continue to demonstrate clinical benefit will be eligible to
receive study drug via an extension of the study, a rollover study, or
through another mechanism. BMS reserves the right to terminate
access to study drug if any of the following occur:
- the MA is rejected by responsible HA
- the study is terminated due to safety concerns
- the subject can obtain medication from a gvt sponsored or private
health program
- therapeutic alternatives become available in the local market.

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

2016-03-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-13

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

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