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1 EU-CTR Version: Home | Search | About | Glossary | Data Quality | Joining a trial | Contacts | EudraPharm EU clinical Trials Register Search for clinical TrialsSummaryEudraCT Number:2010-019173-16 Sponsor's Protocol Code Number:MM5 National Competent Authority:Germany - BfArMClinical Trial Type:EEA CTAT rial Status:OngoingDate on which this record was first entered in the EudraCT database:2010-02-23 IndexA. PROTOCOL INFORMATIONB. SPONSOR INFORMATIONC. APPLICANT IDENTIFICATIOND. IMP INFORMATION ON PLACEBOE. GENERAL INFORMATION ON THE TRIALF. POPULATION OF TRIAL SUBJECTSG. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED P. END OF TRIALA. Protocol Information Member State ConcernedGermany - EudraCT Full title of the trialRandomised phase III trial for previously untreated multiple myeloma to evaluate two regimens of bortezomib based induction therapy and lenalidomide consolidation followed by lenalidomide maintenance of the trial for lay people, in easily understood, non-technical, languageRandomisierte Phase III Studie f r Patienten mit Multiplem Myelom zur Untersuchung zweier Therapieschemata einer Bortezomib-basierten Induktionsthearpie und einer Lenalidomid-Konsolidierungstherapie gefolgt von einer Erhaltungstherapie mmit or abbreviated title of the trial where Sponsor's protocol code (International Standard Randomised Controlled Trial)

2 Is part of a Paediatric Investigation PlanNo Decision number of Paediatric Investigation PlanB. Sponsor Information : Name of SponsorUniversity Hospital and of the Source(s) of Monetary or Material Support for the clinical trial: of organisation providing supportFa. Janssen-Cilag GmbH, of organisation providing supportFa. Celgene, M of organisation providing supportFa. Chugai, Frankfurt am MainPage 1 of 10 clinical Trials of organisation providing supportThe Binding Site, Contact point designated by the sponsor for further information on the trial Name of organisationGMMG Study Functional name of contact point GMMG Address: Street AddressIm Neuenheimer Feld Town/ Post Telephone number00496221568198 Fax IMP Identification.

3 And of the IMP to be used in the clinical trial to be used in the trial has a marketing authorisationYes Trade name of the Marketing Authorisation holderJanssen-Cilag International which granted the Marketing AuthorisationEuropean IMP has been designated in this indication as an orphan drug in the CommunityNo drug designation Description of the form Powder for solution for paediatric formulation No of administration for this IMPS ubcutaneous use to IMP Identification Details (Active Substances) - Proposed number Concentration unit mg milligram(s) Concentration Concentration The IMP contains substance of chemical originYes substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)No The IMP is a: Advanced Therapy IMP (ATIMP) No cell therapy medicinal productNo Gene therapy medical product No Tissue Engineered ProductNo ATIMP ( one involving a medical device)No on Advanced therapies (CAT) has issued a classification for this productNo product that includes a device, but does not involve an Advanced TherapyNo Page 2 of 10 clinical Trials medicinal productNo medicinal product (such as vaccine, allergen, immune serum)No Plasma derived medicinal product No Extractive medicinal productNo Recombinant medicinal product No product containing genetically modified organismsNo Herbal medicinal productNo Homeopathic medicinal product No Another type of medicinal product Yes Other medicinal product typeCytostatic.)

4 And of the IMP to be used in the clinical trial to be used in the trial has a marketing authorisationYes Trade name of the Marketing Authorisation holderCelgene Europe which granted the Marketing AuthorisationEuropean IMP has been designated in this indication as an orphan drug in the CommunityYes drug designation number EU/3/03 Description of the code form Capsule, paediatric formulation No of administration for this IMPOral use to IMP Identification Details (Active Substances) - Proposed number Concentration unit mg milligram(s) Concentration Concentration The IMP contains substance of chemical originYes substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)No The IMP is a: Advanced Therapy IMP (ATIMP) No cell therapy medicinal productNo Gene therapy medical product No Tissue Engineered ProductNo ATIMP ( one involving a medical device)No on Advanced therapies (CAT) has issued a classification for this productNo product that includes a device, but does not involve an Advanced TherapyNo medicinal productNo Immunological medicinal product Page 3 of 10 clinical Trials (such as vaccine, allergen, immune serum))

5 No Plasma derived medicinal product No Extractive medicinal productNo Recombinant medicinal product No product containing genetically modified organismsNo Herbal medicinal productNo Homeopathic medicinal product No Another type of medicinal product Yes Other medicinal product typeImmunomodulatory : and of the IMP to be used in the clinical trial to be used in the trial has a marketing authorisationYes Trade name of the Marketing Authorisation holderCelgene Europe which granted the Marketing AuthorisationEuropean IMP has been designated in this indication as an orphan drug in the CommunityYes drug designation number EU/3/03 Description of the code form Capsule, paediatric formulation No of administration for this IMPOral use to IMP Identification Details (Active Substances) - Proposed number Concentration unit mg milligram(s) Concentration Concentration The IMP contains substance of chemical originYes substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)No The IMP is a.)

6 Advanced Therapy IMP (ATIMP) No cell therapy medicinal productNo Gene therapy medical product No Tissue Engineered ProductNo ATIMP ( one involving a medical device)No on Advanced therapies (CAT) has issued a classification for this productNo product that includes a device, but does not involve an Advanced TherapyNo medicinal productNo medicinal product (such as vaccine, allergen, immune serum)No Plasma derived medicinal product No Page 4 of 10 clinical Trials Extractive medicinal productNo Recombinant medicinal product No product containing genetically modified organismsNo Herbal medicinal productNo Homeopathic medicinal product No Another type of medicinal product Yes Other medicinal product typeImmunomodulatory : and of the IMP to be used in the clinical trial to be used in the trial has a marketing authorisationYes Trade name of the Marketing Authorisation holderCelgene Europe which granted the Marketing AuthorisationEuropean IMP has been designated in this indication as an orphan drug in the CommunityYes drug designation number EU/3/03 Description of the code form Capsule, paediatric formulation No of administration for this IMPOral use to IMP Identification Details (Active Substances) - Proposed number Concentration unit mg milligram(s) Concentration Concentration The IMP contains substance of chemical originYes substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)No The IMP is a.)

7 Advanced Therapy IMP (ATIMP) No cell therapy medicinal productNo Gene therapy medical product No Tissue Engineered ProductNo ATIMP ( one involving a medical device)No on Advanced therapies (CAT) has issued a classification for this productNo product that includes a device, but does not involve an Advanced TherapyNo medicinal productNo medicinal product (such as vaccine, allergen, immune serum)No Plasma derived medicinal product No Extractive medicinal productNo Recombinant medicinal product No Page 5 of 10 clinical Trials product containing genetically modified organismsNo Herbal medicinal productNo Homeopathic medicinal product No Another type of medicinal product Yes Other medicinal product typeImmunomodulatory : and of the IMP to be used in the clinical trial to be used in the trial has a marketing authorisationYes Trade name of the Marketing Authorisation holderCelgene Europe which granted the Marketing AuthorisationEuropean IMP has been designated in this indication as an orphan drug in the CommunityYes drug designation number EU/3/03 Description of the code form Capsule, paediatric formulation No of administration for this IMPOral use to IMP Identification Details (Active Substances) - Proposed number Concentration unit mg milligram(s) Concentration Concentration The IMP contains substance of chemical originYes substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)No The IMP is a.)

8 Advanced Therapy IMP (ATIMP) No cell therapy medicinal productNo Gene therapy medical product No Tissue Engineered ProductNo ATIMP ( one involving a medical device)No on Advanced therapies (CAT) has issued a classification for this productNo product that includes a device, but does not involve an Advanced TherapyNo medicinal productNo medicinal product (such as vaccine, allergen, immune serum)No Plasma derived medicinal product No Extractive medicinal productNo Recombinant medicinal product No product containing genetically modified organismsNo Herbal medicinal productNo Page 6 of 10 clinical Trials Homeopathic medicinal product No Another type of medicinal product Yes Other medicinal product typeImmunomodulatory Information on Placebo E.

9 General Information on the Trial Medical condition or disease under condition(s) being investigated multiple myeloma (symptomatic, newly diagnosed) condition in easily understood language symptomatisches Multiples Myelom, Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]MedDRA being studied is a rare disease Yes Objective of the objective of the trial 1.) Demonstration of non-inferiority of VCD induction therapy compared to PAd induction therapy with respect to response rate (very good partial remission or better; response criteria of the International Myeloma Working Group, IMWG). 2.) Determination of the best of four treatment strategies with respect to progression-free survival (PFS). The four treatment strategies are defined by PAd vs. VCD induction treatment, standard intensification therapy, lenalidomide consolidation and maintenance treatment with lenalidomide for 2 years vs.

10 Lenalidomide until CR. objectives of the trial - overall survival rates (OS) - response rates after lenalidomide consolidation treatment - best response rates - toxicity during induction treatment, lenalidomide consolidation and maintenance treatment with respect to adverse events of CTCAE grade >= 3 contains a sub-study No inclusion criteria newly-diagnosed symptomatic multiple myeloma ("CRAB" criteria) measurable disease age 18 - 70 years (both included) WHO performance status 0-2 (WHO=3 is allowed when caused by myeloma) negative pregnacy test patients must be willing and capable to use adequate contraception written informed exclusion criteria hypersensitivity to any relevant medication within the trial systemic AL-amyloidosis previous chemotherapy or radiotherapy during the past 5 years severe cardiac dysfunc