Myeloma XI. The telephone 24hr randomisation service will remain open throughout this period.

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1 Myeloma XI Continued success for trial! I N S I D E T H I S I S S U E : Easter opening times Recruitment update Easter drug orders Protocol amendment Sites update Data management Central laboratory results Trial contacts 1123 PARTICIPANTS N U M B E R 4 A P R I L Welcome to the fourth Myeloma XI newsletter. The trial is proving enormously successful - we have already recruited more than half the target number of participants, putting us approximately a year ahead of target. Well done to all concerned, our colleagues and associates at the many sites involved with Myeloma XI. As always please distribute this newsletter to all involved in the trial at your hospital. Easter Opening Times CTRU The CTRU will close at 12.30pm on Thursday 5th April and will re-open CTRU at 9am on Wednesday 11th April. The CTRU The 24hr will telephone close at 17:00pm randomisation on Friday service 26th will remain open throughout this period, however you August and will will not receive re-open faxed at 9am confirmation Wednesday of randomisation until CTRU re-opens on the 11th April. 30th August. Please report all SAEs / SUSARs as normal. The telephone 24hr randomisation service will remain open throughout this period. CENTRAL LABORATORIES Please report Please SAEs do not / SUSARs send samples as normal. where the lab is closed on the expected date of delivery. Birmingham: CENTRAL LABORATORIES The labs will be closed for Easter on bank holiday Monday only and will re-open on Tuesday 10th April Please do not send samples where the lab is closed on the expected date of delivery. ICR: The labs will be closed for Easter from Friday 6th April and will re-open Birmingham: The labs will be closed on for Tuesday Bank 10th April holiday from xxxxxxx and will re-open on HMDS: The xxxxxx labs will be open as usual over Easter, although please be aware of the restricted postal service. Samples received on Thursday 5th April will be processed as usual on the Friday. ICR: The labs will be closed from xxxxxxx and will reopen on xxxxx HMDS: The labs will be closed Friday xxxx and will re-open on xxxxxxxxxxxxxx

2 Myeloma XI Recruitment by Centre 1123 participants have been recruited to the trial to date, which continues to be well above target recruitment. March has been the highest recruiting month to date with a record 93 participants randomised into the trial! Many thanks to all sites who have entered a participants, and a special thank you to the current top recruiters: Nottingham University Hospitals who have recruited a total of 51 participants, and Heart of England Foundation Trust (Heartlands and Good Hope Hospital) who have recruited 42 participants. NB: This graph still shows recruitment per centre. Thank you for those who have responded to say they would prefer their recruitment to be presented by Trust; we are working hard to present this in the future. If there are any further teams working across hospitals within a Trust and would like recruitment presented in this way, please let the Data Management Team

3 Lenalidomide ordering dates Dates for Easter and beyond Celgene have been in touch to inform us of the availability of Movianto, the lenalidomide distributors, over the upcoming Easter and bank holidays. Please would you plan your orders in advance of the holidays and fax your orders through to Celgene by no later than 11am on the following days: Holiday Last date/time for next day Order cut off date/time for First available delivery delivery before the holiday delivery after the holiday date after the holiday Easter bank holidays Weds 04 April 2012 at 11:00 am Thurs 05 April 2012 at 11:00 am Tues 10 April 2012 May Day bank holiday Thurs 03 May 2012 at 11:00 am Fri 04 May 2012 at 11:00 am Tues 08 May 2012 Spring Bank and Queen s Jubilee bank holidays Thurs 31 May 2012 at 11:00 am Fri 01 June 2012 at 11:00 am Weds 06 June 2012 It would be helpful if you would telephone or Saadia Ahmad at Celgene ( ; sahmad@celgene.com) to confirm that you have faxed your order through on the above days so that they know to expect it. Myeloma XI protocol version 5.0 Addition of Vorinostat Your R&D departments have been provided with the new protocol and all other documents via CSP (Scottish and Welsh R&Ds have been contacted directly) to enable you to begin the process of obtaining continuing NHS permission for Myeloma XI protocol version 5.0 and returning all the essential documents to the CTRU. A third treatment arm of lenalidomide plus vorinostat will be added to the maintenance randomisation There will be a 1:1:1 randomisation to each arm: lenalidomide, lenalidomide plus vorinostat, or no maintenance Lenalidomide maintenance dose will be reduced from 25 mg to 10 mg Vorinostat will be provided free of charge by MSD Please remember that this amendment cannot be implemented at site until the CTRU has confirmed that all the necessary procedures have been completed. A formal notification of authorisation to implement Myeloma XI protocol version 5.0 will be sent to sites as soon as this has been confirmed. Sites update 104 sites and counting! Since our last Myeloma XI newsletter, in December 2011, we have opened up our 100th site - and beyond! There are now 104 sites open to recruitment on the trial, with a few more to follow. Recent additions include Royal Bolton Hospital, Norfolk and Norwich University Hospital and Royal Oldham Hospital. With well over a thousand participants now randomised, the trial is recruiting well ahead of schedule. Sadly, this means that we will soon not be able to accept any further sites into the study. CRF compliance We d also like to say well done to those sites with excellent compliance for returning baseline and induction CRFs: Perth Royal Infirmary currently has 100% CRF compliance! Trafford General Hospital, Southmead Hospital, and Whiston Hospital all have over 95% compliance, and Nevill Hall, Calderdale Royal, Worcestershire Royal, Royal Preston, and Frenchay all have over 90% compliance! Thank you for your continued effort.

4 Data Management Notes Consent forms A reminder to please not enter additional boxes to the first page of our consent forms for participants to add their initials. Points 1 to 10 of the consent are not optional - the participant agrees to all of these points by signing the form. Only points on the second page of the form are optional and therefore have the boxes for the participant to initial yes or no. Making unnecessary alterations to the consent form can invalidate the consent and create more work in the long run! Consent forms are a legal document and it s important that they are completed correctly. Another common error on the forms is that sometimes the participant and the doctor appear to have signed on different dates. The doctor should go through the trial with the participant, giving them the opportunity to ask questions, and then both should and sign at the same time. The form should then be faxed off to us. Please also send both pages of the Form 03 as we need both the consent form and form three as soon as possible after randomisation. SAE Reporting A number of sites have been sending in the original wet-ink copies of SAE report forms before we have requested them. It is important that you retain the original paperwork for SAEs at site until requested by CTRU. Although you may feel that the SAE is complete we may have further verification to undertake and could request changes. To avoid having to send paperwork backwards and forwards unnecessarily, please hang on to the wet-ink SAEs until we ask for them. Of course, you must continue to fax in new and updated SAE information within 24 hours. 6 Monthly (Pre-progression) Follow-Up Some sites have been telling us they ve been having difficulty completing our Form 12, the 6-monthly (pre-progression) follow-up form. We appreciate that it can be a difficult form to complete so here is some guidance: Form 12s are returned to us every 6 months from the date of initial randomisation until the participant has disease progression (please note progressive disease during induction treatment is not counted). For the first 2 years on the trial, sample collection is as follows: During induction +/- VCD treatment, local and central sample collection is at the time-points specified in the protocol. As these results will be collected on treatment forms already, on Form 12 for this period simply state Please refer to Form xx, cycle xx of Induction / VCD treatment for details on this time point next to the relevant section. Once induction / VCD treatment has been completed, you will need to ensure samples are collected every 2 months and are recorded on Form 12. After 2 years and if the participant remains progression free, they will be followed up every 3 months from then on. The CRF can be completed retrospectively at the end of the 6 month period. At the point of disease progression, complete the Form 12 up to that time, but then no more will be completed. You will then start to complete Form 13 Annual (Post-progression) follow-up. This will be completed annually on the anniversary of initial randomisation in to the trial, regardless of when the participant had disease progression. The Data Management team will be happy to help if you are still unsure, please do not hesitate to contact us. Birmingham laboratory results In order to receive results back from the Birmingham laboratories in a timely manner, you must complete the sample request form in full for every sample which is sent. Please remember to: Write the name of your hospital site in full Complete the Report to be sent to field. Include a.nhs.net address if you wish to receive the results back by If you would like to set up an account to enable the results to be ed back automatically as soon as they are available to a given person or team, please let Jackie Ouzman know the.nhs.net details so that this can be set up for you. Please remember to file all reports in the participant s medical notes once reviewed.

5 Myeloma XI Team Rachel Sigsworth is the main Data Management contact for the trial. Please contact Rachel or another member of the Data Management Team if you have any queries relating to individual participants (including eligibility, treatment etc.), SAE / SUSAR reporting, CRF completion, and randomisation. Rachel Sigsworth Trial Coordinator R.Sigsworth@leeds.ac.uk, Tel: Also in the data management team are Data Management Assistants: Ian Wheeler, D.I.Wheeler@leeds.ac.uk, Tel: Paul McGarry, P.W.McGarry@leeds.ac.uk, Tel: Data Entry Clerks: Helen Turner, H.Turner@leeds.ac.uk, Tel: Asif Farooqui, A.Farooqui@leeds.ac.uk, Tel: Inga Sakauskiene, I.Sakauskiene@leeds.ac.uk, Tel: Data Management Fax: Jacqueline Ouzman is the Trial Management contact, and is responsible for site set up, initiation meetings, protocol amendments, site monitoring and drug supply. Please contact Jackie if you have any queries relating to obtaining local approvals or implementing Myeloma XI protocol version 5.0. Jacqueline Ouzman Senior Trial Coordinator J.Ouzman@leeds.ac.uk, Tel: Fax: Trial postal address: Myeloma XI Trial Office, Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT Chief Investigator: Professor Gareth Morgan, gareth.morgan@icr.ac.uk Co-Investigators: Dr Faith Davies, faith.davies@icr.ac.uk Professor Graham Jackson, graham.jackson@newcastle.ac.uk Professor Nigel Russell, nigel.russell@nottingham.ac.uk