Clinical Trials Register

Summary
EudraCT Number:	2006-004532-73
Sponsor's Protocol Code Number:	CC-5013-MM-019
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:	2006-11-16
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

2006-004532-73

A.3

Full title of the trial

A MULTICENTER, SINGLE-ARM, OPEN-LABEL EXPANDED ACCESS PROGRAM FOR LENALIDOMIDE PLUS DEXAMETHASONE IN PREVIOUSLY TREATED SUBJECTS WITH MULTIPLE MYELOMA

A.3.2

Name or abbreviated title of the trial where available

CC-5013-MM-019

A.4.1

Sponsor's protocol code number

CC-5013-MM-019

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Celgene International Sàrl
B.1.3.4	Country	Switzerland
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	REVLIMID
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Corp.
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/03/177
D.3 Description of the IMP
D.3.1	Product name	Lenalidomide
D.3.2	Product code	CC-5013
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	191732-72-6
D.3.9.2	Current sponsor code	Lenalidomide
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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.2.5	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	Dexamethasone
D.3.2	Product code	Dexamethasone
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	50022
D.3.9.2	Current sponsor code	Dexamethasone
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	8
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Corp.
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/03/177
D.3 Description of the IMP
D.3.1	Product name	Lenalidomid
D.3.2	Product code	CC-5013
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	191732-72-6
D.3.9.2	Current sponsor code	Lenalidomide
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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 or Refractory Multiple Myeloma

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	8.1
E.1.2	Level	PT
E.1.2	Classification code	10028228
E.1.2	Term	Multiple myeloma

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

To determine the time to progression (TTP) of previously treated subjects with multiple myeloma receiving lenalidomide

E.2.2

Secondary objectives of the trial

• To obtain additional safety data
• To assess the time to partial response
• To assess the response rate

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
• Must understand and voluntarily sign an informed consent form.
• Must be ≥ 18 years of age at the time of signing the informed consent form.
• Must be able to adhere to the study visit schedule and other protocol
requirements.
• Must be diagnosed with multiple myeloma that is progressing after at
least 2 cycles of anti-myeloma treatment or that has relapsed with
progressive disease after treatment.
• Subjects may have been previously treated with thalidomide and/or
radiation therapy. In addition, radiation therapy initiated prior to or at
baseline (Day 1) may be given concurrently with study therapy,
provided that all other eligibility criteria are satisfied.
• Subjects must discontinue all anti-myeloma drug or non-drug therapy
prior to the first dose of study drug with the exception of radiation
therapy initiated prior to or at baseline (Day 1).
• Measurable levels of myeloma paraprotein in serum (≥0.5 g/dL) or urine
(≥ 0.2 g excreted in a 24-hour collection sample).
• Eastern Cooperative Oncology Group (ECOG) performance status score of
0, 1, or 2.
• Females of childbearing potential (FCBP) must agree to use two reliable
forms of contraception simultaneously or to practice complete abstinence
from heterosexual intercourse during the following time periods related to
this study: 1) for at least 28 days before starting study drug; 2) while
participating in the study; and 3) for at least 28 days after discontinuation
from the study. The two methods of reliable contraception must
include one highly effective method (i.e. intrauterine device (IUD),
hormonal [birth control pills, injections, or implants], tubal ligation,
partner’s vasectomy) and one additional effective (barrier) method (i.e.
latex condom, diaphragm, cervical cap). FCBP must be referred to a
qualified provider of contraceptive methods if needed.
Before starting study drug:
Female Subjects:
• FCBP must have two negative pregnancy tests (sensitivity of at least 50
mIU/mL) prior to starting study drug.
• Must agree to abstain from donating blood during study participation and
for at least 28 days after discontinuation from the study.

Male Subjects:
• Must agree to use a latex condom during sexual contact with females of
childbearing potential while participating in the study and for at least 28
days following discontinuation from the study even if he has undergone a
successful vasectomy.
• Must agree to abstain from donating blood, semen, or sperm during study
participation and for at least 28 days after discontinuation from the
study.
Female Subjects:
• FCBP with regular cycles must agree to have pregnancy tests weekly for
the first 28 days of study participation and then every 28 days while on
study, at study discontinuation, and at day 28 following discontinuation
from the study.
• Counseling about pregnancy precautions and the potential risks of fetal
exposure must be conducted at a minimum of every 28 days. During
counseling, subjects must be reminded to not share study drug and to not
donate blood.
• Females must agree to abstain from breastfeeding during study
participation and for at least 28 days after discontinuation from the study.

Male Subjects:
• Counseling about the requirement for latex condom use during sexual
contact with females of childbearing potential and the potential risks of
fetal exposure must be conducted at a minimum of every 28 days. During
counseling, subjects must be reminded to not share study drug and to not
donate blood, sperm, or semen.

E.4

Principal exclusion criteria

The presence of any of the following will exclude a subject from study enrolment:
• Any serious medical condition, laboratory abnormality, or psychiatric
illness that would prevent the subject from signing the informed consent
form.
• Pregnant or lactating females.
• Any condition, including the presence of laboratory abnormalities, which
places the subject at unacceptable risk if he/she were to participate in the
study or confounds the ability to interpret data from the study, including
severe uncontrolled diabetes mellitus.
• Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) <1,000 cells/mm3 (1.0 x 10^9/L)
- Platelet count <75,000/mm3 (75 x 10^9/L) for subjects in whom <50%
of the bone marrow nucleated cells are plasma cells.
-Platelet count <30,000/mm3 (30x10^9/L) for subjects in whom >50% of
bone marrow nucleated cells are plasma cells.
- Serum creatinine >2.5 mg/dL (221 μmol/L)
- Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
- Serum total bilirubin >2.0 mg/dL (34 μmol/L)
• Prior history of malignancies other than multiple myeloma (except for basal
cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥1 year.
• Prior history of stroke and / or thromboembolic event
• Known hypersensitivity to thalidomide or dexamethasone.
• Prior history of uncontrollable side effects to dexamethasone therapy.
• The development of a desquamating rash while taking thalidomide.
• Neuropathy ≥Grade 2.

E.5 End points

E.5.1

Primary end point(s)

Time to disease progression

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

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.8.3

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

Information not present in EudraCT

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

Provided in the protcol

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

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.1.3

Elderly (>=65 years)

Yes

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

350

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)

Provided in the protocol.

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

2007-02-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-02-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-03-12

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