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Trial Details
Trial status:
In follow-up (non-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
Note: For enquiries only. DO NOT use for clinical referrals.
Lay summary:
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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 7 days of planned start of treatment (with exceptions)
  • 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
  • Contraindication to the required concomitant medications and supportive treatments.
  • Patients with pleural effusions requiring thoracentesis, or acites requiring paracentesis within 14 days prior to registration
  • Any other clinical significant medical disease or condition
Duration of recruitment: 3.5 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. 
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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.
NameVersionCurrent versRelease dateDownload
Cardamon Protocol v11.0 12/03/2021 - implemented 29/11/202111.0 Current 29/11/2021
Trial documents
NameTypeVersionCurrent versRelease dateDownload
1 Cardamon Preliminary Registration Form v3.0 CRF3.0 Current 20/07/2017
10 Day 100 Post-ASCT Form v3.2CRF3.2 Current 07/10/2019
11 Cardamon Treatment Summary Form v4.0CRF4.0 Current 17/09/2018
12 Maintenance Form v5.0CRF5.0 Current 11/01/2021
13 6 Month Post-start of Maintenance Form v3.2CRF3.2 Current 07/10/2019
14 End of Maintenance Form v3.2CRF3.2 Current 07/10/2019
15 Cardamon Maintenance Summary Form v3.0CRF3.0 Current 07/10/2019
16 1st Progression_Relapse Form v3.2CRF3.2 Current 07/10/2019
17 Cardamon 2nd Progression-Relapse Form v3.0CRF3.0 Current 20/07/2017
18 Follow up/Long Term Follow-up Form v4.1CRF4.1 Current 07/10/2019
19 Cardamon Adverse Event Form v4.0CRF4.0 Current 11/01/2021
2 Full Registration Form v4.2CRF4.2 Current 04/02/2019
20 Withdrawal_Lost to Follow Up Form v4.0CRF4.0 Current 17/09/2018
21 Death Form v3.1CRF3.1 Current 04/07/2019
3 Demographics Form v1.0CRF1.0 Current 17/09/2018
3 Induction Form v4.1CRF4.1 Current 07/10/2019
4 End of Induction Form v4.1CRF4.1 Current 07/10/2019
5 PBSCH PostPBSCH and Randomisation Forms v4.1CRF4.1 Current 07/10/2019
6 Consolidation Form v4.1CRF4.1 Current 07/10/2019
7 Post-Consolidation Form v4.1CRF4.1 Current 07/10/2019
9 Cardamon Transplant Form v3.0CRF3.0 Current 07/10/2019
Cardamon Consent Form v9.0 CleanInformedConsentForm9.0 Current 11/01/2021
Cardamon GP Letter Template v2.0 GPletter2.0 Current 14/03/2018
Cardamon Patient diary booklet - consolidation (cyclo-dex)_v3.0Other3.0 Current 02/11/2018
Cardamon Patient diary booklet - consolidation (dex only)_v3.0Other3.0 Current 02/11/2018
Cardamon Patient diary booklet - induction (cyclo-dex)_v3.0Other3.0 Current 02/11/2016
Cardamon Patient diary booklet - induction (dex only)_v3.0Other3.0 Current 02/11/2016
Cardamon PIS v9.0 CleanPatientInformationSheet9.0 Current 11/01/2021
Cardamon SAE Report_v4.0SAEform4.0 Current 11/01/2021
Cardamon Safety reports additional page - Con Meds v3.1SAEform3.1 Current 11/01/2021
Cardamon Safety reports additional page - Lab tests v2.0SAEform2.0 Current 20/07/2017
Patient Contact Card v2.0 cleanOther2.0 Current 25/02/2018
SAE_report_completion_guidance_for_AESI-COVID-19_v1.0GuidanceDdocument1.0 Current 11/01/2021
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