Change of CKTO number and addition of ‘amendment 1’ with version date on first page Change of planned date end of recruitment into III 2010 (was IV 2008) Change of MR into PR under § 7.2 (Study design, phase II) Deletion of FLC references in definition of Measurable Disease under § 8.1.1 (Inclusion criteria) Addition of History of active malignancy during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma under § 8.1.2 (Exclusion criteria) Change of skeletal radiography every 12 months (was every 6 months) during maintenance and follow up and adjustment of footnote 3 (skeletal survey) in § 11.2.3 (Required investigations) Adjustment of required skeletal survey (footnote 3) in § 11.2 (Required investigations) Rephrasing of § 11.2.5 and § 11.2.6 (Required investigations), concerning Micro-array analysis and SNP analysis Addition of clinically significant in a clinically significant abnormal laboratory finding under § 13.1 (Definitions of (serious) adverse events) Addition of polyneuropathy grade  1 under § 13.2 (Reporting of (serious) adverse events) Addition of section concerning foetal exposure to Lenalidomide under § 13.2 (Reporting of (serious) adverse events) Addition of the product manufacturers under § 13.3 (Processing of (serious) adverse events) Adjustments concerning the Serum free light chain values in the Response Criteria for MM and the definition of measurable disease in appendix B. Replacement appendix H version 11 January 2008 into version 30 January 2009 Adjustments in de Required bone marrow and peripheral blood and logistics in appendix I and J

Removal of “elderly” in study title  Addition of final level (level 2; 1,6 mg/m2 Bortezomib, and 10 mg Lenalidomide, 20 mg Dexamethasone) to Scheme of study  Patient population: removed the restriction of age 60-85 from description, added inclusion criteria: Age ≥18 years  Adjusted the planned end of recruitment to IV 2012  Removed “Age 60-86 years inclusive” from inclusion criteria, added inclusion criteria: Age ≥18 years  Added exclusion criterium: “Patient is unable or unwilling to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan.” Changed treatment table to reflect the final dose level in phase II Added information on Lenalidomide (paragraph 9.3) Added information on SAE and SUSAR reporting to authorities, according to addendum which was previously brought in place Added information on pregnancies (paragraph 13.4) Changed information requested at registering patient from “patient initials” into “local patient code (optional)” + removed request of “Patient’s hospital record number (not obligatory)

Sections regarding SPM added.