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.

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.

Contact the trial team

View trial documents

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.

Name	Version	Current vers	Release date	Download
Cardamon Protocol v11.0 12/03/2021 - implemented 29/11/2021	11.0	Current	29/11/2021

Trial documents

Name	Type	Version	Current vers	Release date
1 Cardamon Preliminary Registration Form v3.0	CRF	3.0	Current	20/07/2017
10 Day 100 Post-ASCT Form v3.2	CRF	3.2	Current	07/10/2019
11 Cardamon Treatment Summary Form v4.0	CRF	4.0	Current	17/09/2018
12 Maintenance Form v5.0	CRF	5.0	Current	11/01/2021
13 6 Month Post-start of Maintenance Form v3.2	CRF	3.2	Current	07/10/2019
14 End of Maintenance Form v3.2	CRF	3.2	Current	07/10/2019
15 Cardamon Maintenance Summary Form v3.0	CRF	3.0	Current	07/10/2019
16 1st Progression_Relapse Form v3.2	CRF	3.2	Current	07/10/2019
17 Cardamon 2nd Progression-Relapse Form v3.0	CRF	3.0	Current	20/07/2017
18 Follow up/Long Term Follow-up Form v4.1	CRF	4.1	Current	07/10/2019
19 Cardamon Adverse Event Form v4.0	CRF	4.0	Current	11/01/2021
2 Full Registration Form v4.2	CRF	4.2	Current	04/02/2019
20 Withdrawal_Lost to Follow Up Form v4.0	CRF	4.0	Current	17/09/2018
21 Death Form v3.1	CRF	3.1	Current	04/07/2019
3 Demographics Form v1.0	CRF	1.0	Current	17/09/2018
3 Induction Form v4.1	CRF	4.1	Current	07/10/2019
4 End of Induction Form v4.1	CRF	4.1	Current	07/10/2019
5 PBSCH PostPBSCH and Randomisation Forms v4.1	CRF	4.1	Current	07/10/2019
6 Consolidation Form v4.1	CRF	4.1	Current	07/10/2019
7 Post-Consolidation Form v4.1	CRF	4.1	Current	07/10/2019
9 Cardamon Transplant Form v3.0	CRF	3.0	Current	07/10/2019
Cardamon Consent Form v9.0 Clean	InformedConsentForm	9.0	Current	11/01/2021
Cardamon GP Letter Template v2.0	GPletter	2.0	Current	14/03/2018
Cardamon Patient diary booklet - consolidation (cyclo-dex)_v3.0	Other	3.0	Current	02/11/2018
Cardamon Patient diary booklet - consolidation (dex only)_v3.0	Other	3.0	Current	02/11/2018
Cardamon Patient diary booklet - induction (cyclo-dex)_v3.0	Other	3.0	Current	02/11/2016
Cardamon Patient diary booklet - induction (dex only)_v3.0	Other	3.0	Current	02/11/2016
Cardamon PIS v9.0 Clean	PatientInformationSheet	9.0	Current	11/01/2021
Cardamon SAE Report_v4.0	SAEform	4.0	Current	11/01/2021
Cardamon Safety reports additional page - Con Meds v3.1	SAEform	3.1	Current	11/01/2021
Cardamon Safety reports additional page - Lab tests v2.0	SAEform	2.0	Current	20/07/2017
Patient Contact Card v2.0 clean	Other	2.0	Current	25/02/2018
SAE_report_completion_guidance_for_AESI-COVID-19_v1.0	GuidanceDdocument	1.0	Current	11/01/2021

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