Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
26/05/2015
Funder:
Amgen
Sponsor:
UCL
Chief Investigator:
Professor Kwee Yong
Recruitment target:
280
EudraCT number:
2014-000506-35
Contact details:
ctc.cardamon@ucl.ac.uk
Lay summary:
Cardamon
Carfilzomib/Cyclophosphamide/Dexamethasone with maintenance carfilzomib in untreated transplant-eligible patients with symptomatic MM to evaluate the benefit of upfront ASCT
Description
Design: Cardamon is a randomised (1:1), multicentre, phase II trial of carfilzomib, cyclophosphamide and dexamethasone (CarCyDex) as induction in untreated patients with symptomatic multiple myeloma who are candidates for ASCT. Patients are randomised after 4 cycles of CarCyDex induction to either a further 4 cycles of CarCyDex (consolidation) or autologous stem cell transplant (ASCT). 
Treatment: All patients receive induction chemotherapy carfilzomib, cyclophosphamide and dexamethasone (CarCyDex) for four 28 day cycles. Responding patients (i.e. response ≥PR) will be randomised to receive either four further cycles of CarCyDex or high dose melphalan with ASCT. After completing the randomised treatment allocation patients who have not progressed may continue on to Carfilzomib maintenance for up to 18 months.
Key inclusion/exclusion criteria:

Inclusion criteria
  • Previously untreated symptomatic multiple myeloma suitable for high dose therapy and ASCT
  • Measurable disease 
  • Age ≥ 18 years
  • Life expectancy ≥ 3 months
  • ECOG 0-2
  • Adequate hepatic, renal and haematological function

Exclusion criteria
  • Pregnant or lactating females
  • Previous treatment for myeloma (with exceptions)
  • Major surgery within 21 days prior to registration
  • Acute active infection within 14 days prior to registration
  • Known HIV or active Hepatitis B or C infection
  • Unstable or uncontrolled angina, myocardial infarction within 4 months prior to registration, or heart failure 
  • Uncontrolled hypertension or diabetes within 14 days prior to registration
  • Non-haematologic malignancy (within past 3 years, with exceptions)
  • Significant neuropathy within 14 days prior to registration
  • Known allergy to captisol

Duration of recruitment: 3 years
Aim
The primary aims of the trial are to determine the efficacy (sCR and ≥VGPR) of (CarCyDex) as induction in untreated patients with symptomatic multiple myeloma who are candidates for ASCT and to evaluate the benefit (PFS at 2 years) of upfront ASCT in patients achieving at least a PR to induction with CarCyDex. 
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
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