Download 3 10 Thalidomide+-Dex Version 1 3 Jul09 (2)

3
Multiple Myeloma
3.10 Regimen name:
Thalidomide (+/- pulsed dexamethasone)
Indications
Non-intensive treatment,
Relapsed or refractory myeloma,
Maintenance therapy
Pre-treatment Evaluation
 Document FBC (with film), plasma viscosity, U&E, creatinine, LFTs, calcium,
glucose, serum free light chain measurements, serum protein electrophoresis and
paraprotein quantitation, CRP, 2-microglobulin and immunoglobulin levels.
 Urine for BJP (and formal evaluation of 24 hour urinary BJP excretion if light chain
only myeloma).
 Bone marrow aspirate ± trephine (and cytogenetics if part of local protocol).
 Skeletal survey.
 Document WHO performance status of patient.
 Document height and weight and surface area.
 Consider ECG ± echocardiogram if clinical suspicion of cardiac dysfunction.
 Give adequate verbal and written information for patients and relatives concerning
patient’s disease, treatment strategy and side effects.
 Obtain written consent from patient or guardian.
Drug Regimen
Drug
(OPCS code: X70.5)
Day
Dose
Route
100mg – 200mg daily for PO
Continuously Thalidomide
2 weeks, increasing by
50mg every week
up to 800mg daily if
tolerated
See Concurrent Medication section for Dexamethasone dosing.
MAINTENANCE DOSING
Drug
Dose
50mg daily for 4 weeks,
Continuously Thalidomide
increasing to
100mg daily if tolerated
Day
Route
PO
Comments
At night
Comments
At night
Considerations

Incidence of thromboembolic events increases when thalidomide is given in
combination with dexamethasone and/or chemotherapy.

Incidence of VTS occurring with single agent thalidomide is <5%.

For more information consult the UKMF/BCSH Guidelines
www.ukmf.org.uk/guidelines/thalidomide.
Thalidomide is a known teratogenic agent.
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The conditions of a Pregnancy Prevention Programme must be fulfilled for all
patients unless there is reliable evidence that the patient does not have
childbearing potential.
A female patient or a female partner of a male patient is considered to have
childbearing potential unless she meets at least one of the following criteria:
1. • Age 50 years and naturally amenorrhoeic for 1 year*
2. • Premature ovarian failure confirmed by a specialist gynaecologist
3. • Previous bilateral salpingo-oophorectomy, or hysterectomy
4. • XY genotype, Turner syndrome, uterine agenesis.
*Amenorrhoea following cancer therapy does not rule out childbearing potential.
For women of childbearing potential, thalidomide is contraindicated unless all of the
conditions of a Pregnancy Prevention Programme (PPP) are met

Thalidomide must be discontinued and all supplies returned if the patient or a male
patient’s partner becomes pregnant or pregnancy is suspected (positive pregnancy
test). If using the Pharmion brand, this should then be reported to the Pharmion
Risk Management Centre.
Cycle Frequency
Continuous
Dose Modifications
If a thromboembolic event eg.DVT or PE occurs the thalidomide should be stopped
until good anticoagulant control is established using standard treatment guidelines.
The thalidomide may be restarted, as long as there are no other adverse events, at
50mg daily, increasing to maximum tolerated dose if anticoagulant control remains
stable and there are no other adverse events.
Grade 3 – 4 toxicity of any of the major adverse effects (constipation, neuropathy,
fatigue, sedation, rash, tremor and oedema) would necessitate;
- stopping the thalidomide until adverse event resolved,
- reintroduce at 50mg daily,
- escalate to maximum tolerated dose.
Investigations prior to subsequent cycles


FBC, U&E, creatinine, LFTs, paraprotein level or urinary protein/BJP excretion,
plasma viscosity.
Reassess disease response after each cycle, and then 6 weekly during plateau
phase.
Treatment duration
 Until disease progression
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Concurrent Medication
 Allopurinol 300mg (or 100mg if creatinine clearance <20mls/min) od po during the
first month.
 Dexamethasone (if used) 20-40mg daily for 4 days every 2-4 weeks. Reduced sideeffects are seen with 20mg dose.
 H2-antagonist or PPI is advised for patients receiving Dexamethasone.
 Consider oral systemic anti-bacterial, anti-viral and/or anti-fungal prophylaxis if
patient is neutropenic - refer to local protocol.
 Bisphosphonates
Anti-emetics
 This regimen has mild emetic potential
Adverse Effects
See patient information
References
 Singhal S, Mehta J, Desikan R et al. Antitumor activity of Thalidomide in refractory
multiple myeloma. NEJM 1999; 341: 1565-1571.
 Barlogie B, Desikan R, Eddleman P et al. Extended survival in advanced and
refractory myeloma after single agent Thalidomide: identification of prognostic
factors in a Phase 2 study of 169 patients. Blood 2001; 98: 492-494.
 Durie BGM & Stepan DE. Low dose Thalidomide alone and in combination: longterm follow-up. Blood 2001; 98 (Suppl 1): 163a.
 Wechalekar AD, Sutton D, Voralia et al. Intermediate dose Thalidomide (200 mg
daily) has comparable efficacy and less toxicity than higher doses in relapsed
multiple myeloma. Blood 2001; 98 (Suppl 1): 162a.
 Weber DM, Gavino M, Delasalle K et al. Thalidomide alone or with Dexamethasone
for multiple myeloma. Blood 1999; 94 Suppl 1: 604a.
 Rajkumar SV, Hayman SR, Gertz MA et al. Combination therapy with Thalidomide
plus Dexamethasone (THAL/DEX) for newly diagnosed myeloma. Blood 2001; 98
(Suppl 1): 849a.
Patient Information
http://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Biolo
gicaltherapies/Angiogenesisinhibitors/Thalidomide.aspx
http://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Supp
ortivetherapies/Steroids.aspx
Written/ revised by: Dr S Abdalla, Stephanie Kirschke, Pauline McCalla and Dr A Rahemtulla
Authorised by:
WLCN Haematology TWG September 2009
Date for review by Haematology TWG: September 2010
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