Melphalan, Prednisolone and Thalidomide
Regimen
Indication
Multiple myeloma
Therapeutic Intent
Disease modification
Day
Medication
Dose
Route
Administration Details
1 to 4
Melphalan
7mg/m2
PO
Round to nearest 2mg
1 to 4
Prednisolone
40mg/m2
PO
Once daily as a single dose in the morning
1 to 28
Thalidomide
100mg
PO
Once a day in the evening
Increase by 50mg every 2 weeks (if tolerated) to
maximum of 200mg daily
Cycle Frequency
Tests required prior to
initiation of course
Tests required prior to
individual cycle
Concurrent Medication
Every 28 days up to a minimum of 6 cycles and a maximum of 9 cycles
FBC, LFT, U+E, bone profile, glucose
Serum Igs/ electrophoresis/ serum free light chains
Neurological assessment for neuropathy
FBC, LFT, U+E
Serum Igs/ electrophoresis/ serum free light chains (if indicated)
Neurological assessment for neuropathy
Allopurinol (during 1st cycle)
PPI
Anti-emetics as per local policy
GCSF support as per local policy
Antimicrobial prophylaxis as per local policy – include PCP and antiviral
prophylaxis
Bisphosphonate monthly
Laxatives
Anticoagulation – options include prophylactic dose of a LMWH, treatment
dose LMWH in high risk patients or full anti-coagulation with warfarin (to
achieve a target INR of 2-3). If these 2 options are not considered suitable,
aspirin 75-300mg may be considered. Patients at higher risk of thrombosis
should receive full anti-coagulation.
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Dose Modifications
Hepatic
No hepatic dose modifications
Renal
If serum creatinine >200umol/l – reduce dose of melphalan to 5mg/m2 in the first
course and titrate against marrow toxicity for subsequent courses (although
melphalan is hydrolysed and excreted via the kidneys, the extent of drug
accumulation is variable in each individual and cannot be predicted from the degree
of renal impairment)
If cytopenias (i.e. neutrophils <1x109/L and platelets <75 x109/L) are considered to
be chemotherapy- induced:
 Delay treatment for 1 to 2 weeks; delay of more than 2 weeks on more than
one occasion would be an indication to give GCSF or consider a dose
reduction of melphalan to 75%
 Add GCSF (usually only minimal dose required 2 to 3 days per cycle).
Thalidomide-related grade 1-2 toxicity, but sometimes grade 3-4 toxicity, may be
encountered and include constipation, neuropathy, fatigue, sedation, rash, tremor
and oedema. Grade 3-4 toxicity is an indication to stop thalidomide for the
remainder of the current cycle and then re-introduce at 50 mg daily with the next or
subsequent cycle. Assuming tolerance at the lower dose level, escalation to 100 mg
daily may be considered, and possibly to 150 mg or the full dose of 200 mg daily if
the symptoms resolve and do not recur.
The occurrence of a thromboembolic event such as a DVT or pulmonary embolism is
an indication for full anticoagulation following standard treatment guidelines.
Thalidomide may be stopped, but can be re-introduced, assuming good
anticoagulant control and no other untoward side effects.
Haematological
Neurotoxicity
Thromboembolism
Additional Information
Thalidomide must be supplied via an MHRA approved risk management
programme only.
Refer to thalidomide SPC (available at www.medicines.org.uk) for further
information on thalidomide risk management programme run by Celgene.
References
Palumbo et al. Oral melphalan and prednisone chemotherapy plus
thalidomide compared with melphalan and prednisone alone in elderly
patients with multiple myeloma: randomized controlled trial. Lancet 2006;
367: 825-31.
Author
Pharmacy CNG
Approved & Checked by
Haematology CNG (Review Date = Sept 2017)
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