Bubble

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. 

• Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]
• Delegation Log [.pdf]

Links to the current protocol, Patient Information Sheet, Informed Consent Form are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.

Other documents (e.g. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, GP Letter, Release of Medical Information Form etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the Bubble Trial Office.

• Protocol v3.0 [.pdf]
• Patient Information Sheet and Consent Form v3.0 [.docx]
• Release of Medical Information Form v1.0 [.docx]
• GP Letter v2.0 [.docx]
• Patient Cards v1.0 [.pdf]
• Patient Diary v2.0 [.pdf]

 Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Version Control List. Links to the Investigator Site File Version Control Lists used in this trial are below in reverse date order.

• Investigator Site Version Control List v7.0 [.pdf]
• Investigator Site Version Control List v6.0  [.pdf]
• Investigator Site Version Control List v5.0  [.pdf]
• Investigator Site Version Control List v4.0  [.pdf]
• Investigator Site Version Control List v3.0  [.pdf]
• Investigator Site Version Control List v2.0  [.pdf]
• Investigator Site Version Control List v1.0  [.pdf]

 Amendments

Below is a link to a document which lists all of the substantial protocol amendments which have been made for this trial. The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

• Bubble Amendments (opens new page)

 Guidelines

• SAE Form Completion Guidelines  [.pdf]
• Sample Collection Guidlines  [.pdf]
• Self Rating Mood Scale Booklet v1.0  [.pdf]

 Other Trial Documents

• Quality of Life Questionnaire [.pdf]
• PI Protocol Signature sheet [.pdf]

• Registration Form  [.pdf]
• Eligibility Form [.pdf]
• Medical History Baseline Form  [.pdf]
• Treatment Cycle 1 Form  [.pdf]
• Treatment Cycle 2 Form  [.pdf]
• Treatment Cycle 3 Form  [.pdf]
• Treatment Cycle 4 Form  [.pdf]
• Treatment Cycle 5 Form  [.pdf]
• Treatment Cycle 6 Form  [.pdf]
• Treatment Cycle 7 Form  [.pdf]
• Treatment Cycle 8 Form  [.pdf]
• Concomitant Medication Form  [.pdf]
• Adverse Events Cycle 1 Form    [.pdf]
• Adverse Events Form Cycles 2-  [.pdf]
• Follow Up Form [.pdf]
• Disease Progression Form  [.pdf]
• Treatment Discontinuation Form  [.pdf]
• Withdrawal of Consent Form  [.pdf]
• Death Form [.pdf]
• Deviation Form  [.pdf]

• SAE Form  [.pdf]
• Electronic SAE Form [.pdf]
• Expected SAR Form [.pdf]
• SAE Fax Cover Sheet  [.pdf]

• Sample Collection Form [.pdf]
• Sample Collection Log [.pdf]

Pharmacy Documents

• Pharmacy Manual v2.0 [.pdf]
• Bortezomib order form  [.pdf]
• Buparlisib order form  [.pdf]
• Bortezomib SPC [opens a new window]
• Velcade SPC [.pdf]

 Pharmacy File Version Control Checklists

• Pharmacy Version Control Checklist v6.0 [.pdf]
• Pharmacy Version Control Checklist v5.0 [.pdf]
• Pharmacy Version Control Checklist v4.0 [.pdf]
• Pharmacy Version Control Checklist v3.0 [.pdf]
• Pharmacy Version Control Checklist v2.0 [.pdf]
• Pharmacy Version Control Checklist v1.0 [.pdf]

To date there are no publications for this trial.

Bubble opened to recruitment on 23 June 2016!

We welcome expressions of interest from potential new sites - contact the Bubble Trial Office using the details below.

Chief Investigator
Professor Kwee Yong 
University College London (UCL) Cancer Institute
72 Huntley Street
London
WC1E 6DD

Tel:  +44 (0)207 679 6139
Fax: +44 (0)207 679 6222

Bubble Trial Office

Trial Coordinator:    Godwill Iheagwaram                                
Trial Monitor:    Saika Kauser 
Trial Management Team Leader:    Shamyla Siddique 
Trial Statistician:    Ikhlaaq Ahmed

Cancer Research UK Clinical Trials Unit (CRCTU)
Department of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

Enquiries
Telephone: +44 (0)121 415 9175 or 9176
Fax:              +44 (0)121 414 6061
Email:          Bubble@trials.bham.ac.uk

Trial Entry
Telephone: +44 (0)121 415 9175 or 9176                       (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting
Fax: +44 (0)121 414 6061   Or    +44 (0) 121 414 3700

Sponsor
The trial is sponsored by the University of Birmingham.