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Myeloma group
Summary of changes (2013):
Tabulation of dose modification
Change of emetic risk


As initial therapy or at relapse in patients thought unsuitable for CTD / autografting.


1. Ensure all the following staging investigations are done:
o FBC & film o Clotting screen o U&Es o LFTs o Calcium o Albumin o Uric acid o Urine collection for creatinine clearance (CrCl), total protein, light chain (Bence Jones) o Electrophoresis and immunofixation for quantitation of serum paraprotein and o Serum free light chain assay (Freelite) o β2 microglobulin o Group and save o Pregnancy testing for pre-menopausal women younger than 55 before each cycle o Skeletal survey (skull, whole spine, pelvis, all proximal limbs, CXR) o MRI if suspicion of spinal cord compression o MRI or PET-CT if clinically indicated for suspected disease not detected by conventional o Bone marrow aspirate and trephine (with immunophenotyping for kappa/lambda if Additional investigation:
o Plasma viscosity if hyperviscosity suspected 2. Hydration - ensure fluid intake of at least 3 litres per day. 3. Fertility - all relevant patients should be offered fertility advice and sperm storage if appropriate. 4. Counselling - all patients should receive verbal and written information on the toxicity and teratogenicity of thalidomide highlighting need for safe drug storage and to take adequate contraceptive measures for both sexes. Celgene (Pharmion) thalidomide is the only licensed product and should be used. Patients must read the patient information documents from the company. This is a controlled document and therefore must not be changed or photocopied
Myeloma group
5. Consent - ensure patient has received adequate verbal and written information regarding their disease, treatment and potential side effects. Document in medical notes all information that has been given. Obtain written consent for the treatment including signing Celgene risk management programme forms (see web page for links).

100 mg/day orally. Usually start with 50 mg/day for first week. Melphalan
Prednisolone 40 mg/m2 oral daily for 7 days
NB: Dose of prednisolone may be reduced in the very elderly or if significant toxicity occurs

Every 4 weeks until plateau phase (paraprotein level stable for 3 months) and then stop.


• Pregnant, or breast-feeding women - absolute contraindication.
• Patients with known sensitivity to thalidomide or any of the excipients.
• Women of childbearing potential who are not using or are not able to use adequate
contraceptive measures to prevent pregnancy. • Men who are not willing or able to comply with contraceptive measures.

• Neutrophil count should be > 1.0 x 109/L and platelet count should be > 75 x 109/L before
melphalan treatment, unless low counts are thought to be due to myeloma per se. • The melphalan dose should be reduced if severe myelotoxicity occurs, alternatively consider • If the nadir neutrophil count is > 1.5 and nadir platelets > 100, consideration may be given to a cautious increase in melphalan dose for subsequent cycles.
consider dose reduction on subsequent cycles

This is a controlled document and therefore must not be changed or photocopied
Myeloma group
Neuropathy: Thalidomide should be stopped or reduced if there are symptoms of progressive
peripheral neuropathy causing functional disability. If the drug is stopped, re-introducing
thalidomide after a two-week gap at 50 mg/day with subsequent cautious dose escalation should
be considered if symptoms permit.

Venous thromboembolism (VTE)
: There is an increased risk of thrombosis particularly in newly
diagnosed patients and some form of prophylaxis is strongly recommended as follows. LMW
Heparin, Warfarin or aspirin can be used for thromboprophylaxis in low risk patients.6 LMW
Heparin or Warfarin is generally preferred for higher risk patients with additional risk factors such
as immobility. If VTE occurs, thalidomide can be continued and the patient should be fully
anticoagulated according to standard guidelines.

INVESTIGATIONS – prior to each cycle of treatment

• FBC - monthly.
• U&E, LFTs, Ca++ - monthly.
• Ig's, paraprotein, or Freelite assay if appropriate, usually monthly after first 2 months.
• Pregnancy testing on pre menopausal women younger then 55 prior to each cycle.


• Allopurinol 300 mg daily for 7 days with first cycle only.
• Prescribe prophylactic laxatives to be taken if needed.
• Consider proton pump inhibitor and/or fluconazole if steroid related side effects develop.
• Bisphosphonates as per protocol.
• Thromboprophylaxis, see above.
• Consider co-trimoxazole prophylaxis if previous autograft.
• Consider prophylactic Acyclovir 200 mg tid if previous herpetic infection.


Low emetic risk

Teratogenic: A risk management programme should be observed. The concomitant use of 2
effective methods of contraception is mandatory in all female patients of childbearing potential. Male patients should also use a condom when having sexual intercourse with women of childbearing potential. • Drowsiness, somnolence and sedation: Take the dose at night time. Thalidomide may
potentiate the drowsiness caused by alcohol and other sedative medication. If affected, patients should be instructed not to drive cars, use machinery or perform hazardous tasks whilst taking thalidomide. • Peripheral neuropathy: Patients should be advised to report prickling, numbness and
This is a controlled document and therefore must not be changed or photocopied
Myeloma group
Dizziness and orthostatic hypotension: Patients should be advised that thalidomide may
cause orthostatic hypotension and that they should sit upright for a few minutes prior to standing up from a recumbent position. • Other warnings: Patients should be informed not to donate blood or semen during or within 8
weeks of stopping thalidomide treatment.

1. Smith A, Wisloff F, Samson S, the UK Myeloma Forum, Nordic Myeloma Study Group and British
Committee for Standards in Haematology: Guidelines on the diagnosis and management of multiple myeloma 2005. 2. Cavenagh JD, Oakervee H; UK Myeloma Forum and the BCSH Haematology/Oncology Task Forces. Thalidomide in multiple myeloma: current status and future prospects. Br J Haematol. 2003 Jan;120(1):18-26. 3. eMC UK Summary of Product Characteristics for Thalidomide, Celgene, August 2011. 4. Palumbo A, Bringhen S, Caravita T, et al; Italian Multiple Myeloma Network, GIMEMA. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet. 2006 Mar 11;367(9513):825-31. 5. Facon T, Mary JY, Hulin C, et al; Intergroupe Francophone du Myélome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18. 6. Palumbo A et al. A Phase III Study of Enoxaparin vs Aspirin vs Low-Dose Warfarin as Thromboprophylaxis for Newly Diagnosed Myeloma Patients Treated with Thalidomide Based-Regimens. Blood (ASH Annual Meeting Abstracts) 2009 114: Abstract 492. This is a controlled document and therefore must not be changed or photocopied



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