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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
09/03/2011
Funder:
Leukaemia & Lymphoma Research
Sponsor:
UCL
Chief Investigator:
Dr Kwee Yong
Recruitment target:
120
EudraCT number:
2010-021598-35
Contact details:
ctc.padimac@ucl.ac.uk
Lay summary:
PADIMAC
Phase II study of Bortezomib, Adriamycin and Dexamethasone (PAD) therapy for previously untreated patients with multiple myeloma: Impact of minimal residual disease (MRD) in patients with deferred ASCT.
Description
Design: PADIMAC is non-randomised, single arm, multicentre phase II  trial  evaluating the safety of multiple myeloma patients that have achieved a Complete Response (CR) or Very Good Partial Response (VGPR) post induction therapy on the Bortezomib, Adriamycin and Dexamethasone (PAD) regimen not proceeding to have an Autologous Stem Cell Transplant (ASCT).  
Treatment: Previously untreated multiple myeloma patients will receive PAD (4-6 21 day cycles). After PAD therapy, patients with less than a partial response (PR) will be offered salvage treatment before proceeding to autologous stem cell transplant (ASCT). Patients achieving PR will undergo peripheral blood stem cell harvest (PBSCH) and proceed to High Dose Therapy (HDT) and ASCT. Patients in complete response (CR) or very good partial response (VGPR) will undergo PBSCH and will receive no further treatment. These patients will be offered ASCT at relapse, if appropriate. 
Key inclusion/exclusion criteria:

Inclusion
  • Previously untreated patients with symptomatic myeloma 
  • Suitable for high dose therapy and ASCT
  • Age ≥18 years 
  • ECOG 0-3
  • Measurable disease
  • Adequate hepatic, renal and haematological function
  • Adequate pulmonary function
  • Cardiac ejection fraction 40% by echocardiography or MUGA scan 

Exclusion
  • Grade 2 or worse peripheral neuropathy or neuropathic pain 
  • Known allergy contributable to compounds containing boron or mannitol
  • Active infection with HIV, hepatitis B or C
  • Pregnant or lactating women

Duration of recruitment: 2 years
Aim
The overall aim of the trial is to provide a reliable estimate of the 2-year progression free survival for patients who receive no further treatment after achieving a major response to induction therapy with PAD.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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