Abstracts of Clinical Meeting on 12-July-2002
Thalidomide Maintenance Following High Dose Therapy In Multiple Myeloma: A Phase 2 Study
Rod Johnson; Consultant Haematologist, Birmingham Heartlands Hospital,
Birmingham. B9 5SS
Graham Jackson: Consultant Haematologist, Royal Victoria Infirmary, Newcastle.
NE1 4LP
This trial is set to recruit 50 patients in 5 x 10 patient cohorts. Each cohort goes onto a set dose as follows: 50, 100, 200, 250, 300mg. Treatment starts 3 months post PBSCT and continues forever.
MREC approval has been obtained and LREC approval has been sought in the following centres:
- Birmingham Heartlands (Approved)
- Royal Victoria Infirmary, Newcastle (Approved)
- Torbay (Approved)
- Western Infirmary Glasgow (Approved)
- Leicester Royal Infirmary (Approved)
- Christie Hospital, Manchester (Approved)
- John Radcliffe Hospital, Oxford (Approved)
- The General Infirmary at Leeds (In process)
- Queen Elizabeth, Birmingham (In process)
At present there are 15 patients in the study recruited from 5 centres and 5 others notified and waiting to reach 3 months to start the drug.
50mg - 6 patients
100mg - 9 patients
The 50mg cohort was 'underfilled' due to a data management mix up and we have now centralised the collection at Heartlands to avoid any further problems and so that we can clearly assign doses to new entrants.
The earliest patients started the study drug in February this year so outcome data is not possible as yet but there are a couple of comments to make:
- One patient out of 9 has been dose reduced from 100 to 50 due to lethargy
- One patient was mistakenly dose escalated to 200mg and developed neuropathic symptoms. They were de-escalated to 50mg and the symptoms have resolved.
- One patient on 100mg developed a DVT (successfully treated) and is off study (MREC + LRECs informed)
I suspect that the target of 50 is very likely to be achieved if the current centres stay with us and Leeds / QE join and I am optimistic that useful outcome data should be available. Realistically this looks like being about a year away but with results on the earlier cohorts sooner.