Intravenous Mel Dex July 08 Checked in Date Oct 2011

ROYAL FREE & UNIVERSITY COLLEGE MEDICAL SCHOOL
NATIONAL AMYLOIDOSIS CENTRE
Prof PN Hawkins PhD FRCP FRCPath Clinical Director

020 7433 2815 (PA 2816) [email protected]
Prof MB Pepys FRS, Head, Dept of Medicine

020 7433 2802 [email protected]
Dr JD Gillmore MD PhD MRCP, Senior Lecturer

Dr HJ Lachmann MD MRCP, Senior Lecturer

Dr AD Wechalekar MD MRCP MRCPath, Senior Lecturer

General Enquiries: 020 7433 2725

Ramon Lamarca (Unit Secretary) 020 7433 2811
INTERMEDIATE DOSE INTRAVENOUS MELPHALAN

TREATMENT REGIMEN USED IN AL AMYLOIDOSIS
Stem cell harvesting with G-CSF alone (or with cyclophosphamide (1-2g/m2) + G-CSF in case of failure with
G-CSF alone) should be considered in all patients (aged 70 yrs) who may be potential ASCT candidates prior
to administration of melphalan.
Intravenous Melphalan dexamethasone regime:
2
Day 1:
Intravenous Melphalan 25mg/m , given as an infusion in 100ml saline over 30 minutes

(central line not required)
Days 1 - 4:
Dexamethasone 20mg po daily
If tolerated, the cycle is repeated every 28 days continuing to maximal response with a minimum of 2 cycles.
All patients should receive antimicrobial, antifungal and antiviral prophylaxis as per local protocols for
chemotherapy regimes likely to cause significant neutropenia
The regimen is usually delivered as an outpatient. Patients with very poor performance status or as
individually indicated may be observed as an inpatient for an appropriate duration during or after the
treatment.
This protocol is moderately myelosuppressive and all patients will need appropratiate haematologic
monitoring.
Suggested dose modification of Intravenous Mel-Dex:

a) Adjustments for neutropenia and/or thrombocytopenia: Myelosuppression is a common feature
9
with this regime. Next cycle should not commence until neutrophils are >1 x 10 /L and platelets
9
>75 x 10 /L. If count recovery is delayed beyond 28 days, patients should receive G-CSF for 7 days
from day 5 of the next cycle. CAREFUL FLUID BALANCE MONITORING IS NEEDED DURING G-CSF
TREATMENT. In case of cytopenia delaying chemotherapy 2 weeks the next cycle should consist of
dose reduction of melphalan or consider switching to another regime.
b) Dexamethasone Toxicity: Patients with AL amyloidosis are prone to dexamethasone toxicity and will
require careful monitoring. The main toxicity in such patients is likely to be fluid overload, in which case
diuretic therapy should be optimized, if necessary by addition of spironolactone. Patients often need
frequent diuretic adjustments. Albumin infusions can help to optimize fluid management in
hyopalbuniaemic patients. If the response to additional diuretic therapy is inadequate, step-wise
National Amyloidosis Centre, Royal Free & University College Medical School, Rowland Hill Street, London NW3 2PF, UK
Fax: +44 (0)20 7433 2817 www.ucl.ac.uk/medicine/nac
dexamethasone dose reduction by 6 mg or changing to weekly schedule may be considered. Switching

to an alternative corticosteroid, e.g. methylprednisolone, is unlikely be of major benefit as the
mineralocorticoid action is greater for most other corticosteroids than for dexamethasone at comparable
doses.
c) Adjustment for renal insufficiency: The dose of melphalan should be reduced appropriately in
patients with significant renal impairment.
Assessment of response and duration of therapy:
All patients should have measurements of the serum free light chain concentration (and paraprotein if detectable
at the onset to treatment) at the end of each cycle of chemotherapy. We can provide this service at the NAC.
Serum or clotted whole blood samples should be sent through the post at ambient temperature and a kit for this is
provided to patients.
Treatment, if tolerated, should be pursued to plateau or best response. We would seldom recommend more than
4 cycles of this protocol, and 3 may be sufficient.
1. ALL PATIENTS MUST BE RE-ASSESSED FOR CLONAL RESPONSE AT THE END OF THE THIRD
CYCLE AND PATIENTS WHO SHOW NO CLONAL RESPONSE AT ALL MUST BE CONSIDERED
FOR AN ALTERNATIVE REGIME.
2. At this time patients who have achieved a complete response (monoclonal protein no longer detectable
and normal free light chains) may stop or receive one further cycle after achievement of CR.
3. Treatment should continue to a plateau or CR for all other patients unless toxicity/adverse events deem
further chemotherapy undesirable.
Choices about continuing or changing treatment will also be governed by the acceptability and adverse effects of
chemotherapy.
Please direct any queries to any of the following:

Dr Julian Gillmore
Dr Ashutosh Wechalekar
Dr Helen Lachmann
Prof Philip Hawkins
020 7433 2726

0207433 2758
020 7433 2804
020 7433 2815
[email protected]
[email protected]
[email protected]
[email protected]
National Amyloidosis Centre, Royal Free & University College Medical School, Rowland Hill Street, London NW3 2PF, UK
Fax: +44 (0)20 7433 2817 www.ucl.ac.uk/medicine/nac

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ROYAL FREE & UNIVERSITY COLLEGE MEDICAL SCHOOL

NATIONAL AMYLOIDOSIS CENTRE

Prof PN Hawkins PhD FRCP FRCPath Clinical Director

Prof MB Pepys FRS, Head, Dept of Medicine

Dr JD Gillmore MD PhD MRCP, Senior Lecturer

Dr HJ Lachmann MD MRCP, Senior Lecturer

Dr AD Wechalekar MD MRCP MRCPath, Senior Lecturer

General Enquiries: 020 7433 2725

INTERMEDIATE DOSE INTRAVENOUS MELPHALAN

Intravenous Melphalan 25mg/m , given as an infusion in 100ml saline over 30 minutes

Dexamethasone 20mg po daily

Suggested dose modification of Intravenous Mel-Dex:

dexamethasone dose reduction by 6 mg or changing to weekly schedule may be considered. Switching

Please direct any queries to any of the following:

020 7433 2726

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