TEAMM schedule
TEAMM Schedule Version 3.1, August 2012
Myeloma Diagnosis
We will request the results of the following standard diagnostic investigations:
• FBC+ESR/viscosity, urea and electrolytes, creatinine, calcium, albumin, serum protein and urine electrophoresis, serum
and urine paraprotein typing and quantitation, immunoglobulins, β2microglobulin, +/- serum free light chains
• Skeletal Survey +/-MRI scan
• Bone marrow aspirate and +/- trephine
CHECK ELIGIBILITY
Trial Entry
Eligibility Criteria:
• Age ≥ 21 years and able to give informed consent
• Patient with newly diagnosed symptomatic myeloma based on internationally agreed criteria (see appendix 1 for
diagnostic criteria).
• There is an intention to treat the patient’s myeloma actively
• Patient that is no more than 14 days prior to or no more than 14 days into starting a programme of anti-myeloma
therapy
• Provision of written informed consent
Exclusion Criteria:
• Patients with contraindication to Levofloxacin:• known to have sensitivity / allergy to Levofloxacin or other quinolones
• Patients with a history of tendon disorders related to fluoroquinolone administration
• Patients receiving other antibacterial prophylaxis (excluding pneumocystis prophylaxis if regarded as
essential)
• Patients receiving amiodarone or arsenic trioxide
• Patients on active antiepileptic treatment
• Women of childbearing age who are not willing to use appropriate methods of contraception to prevent pregnancy or
women that are breastfeeding
• Patient thought to have mandatory requirement for antibacterial prophylaxis
• Previous treatment for myeloma, except for the following:
• Local radiotherapy to relieve bone pain or spinal cord compression
• Prior bisphosphonate treatment
• Previous (<5 years since diagnosis) or concurrent active malignancies except surgically removed basal or squamous cell
carcinoma of the skin, treated carcinoma insitu of the breast or cervix, or incidental histologic finding of prostate
cancer (TNM stage of T1a or 1b). Patients with remote histories (>5 years) of other cured malignancies may be entered.
CONSENT
Assessments Prior to treatment/randomisation:
• Full medical history including height, weight, ECOG performance status
• Criteria fulfilled for a diagnosis of symptomatic myeloma.
• Assessment of whether suitable for intensive treatment or not
• Calculate eGFR using most recent creatinine
• Quality of Life questionnaire
Samples to send to Birmingham
• BLOOD clotted 12-20mls (2x red topped tubes)
• BLOOD EDTA 8mls (2x purple topped tubes)
• Random Urine sample 20mls (Universal Supplied)
eGFR web calculator:
http:www.renal.org/eGFRcalc/
Samples to send to St Georges
• Nasal and stool sample to be taken with
equipment supplied
RANDOMISATION
Tel: 024 76 150402 (Mon-Fri, 9am to 5pm) Fax: 024 76 151586
Week 0 – Appointment 1
• Supply patient with trial drug , inform of appropriate dose (supply with tablet cutter as required)
• Provide patient with Patient Diary and Thermometer
• Train and assess patient and/or carer on how to take oral temperature and fill in diary
• Provide patient with stool sampling kit for providing a stool sample prior to next appointment
Treatment should commence no later than 14 days into starting anti-myeloma therapy
Week 4 (+/- 2 weeks) – Appointment 2
• Locally: FBC, U+E, creatinine (eGFR), calcium, Igs, serum +/- urine paraprotein quantitation, +/- SFLC
• Clinical and performance status assessment inc. weight
•Assessment for infections, adverse events, myeloma response, compliance, supportive care given, chemotherapy
given & QOL
• Review diary for case report form (CRF) translation (please post diary to TEAMM trial office)
• Supply patient with new diary, stool sampling kit and universal bottle for urine sample
• Review eGRF and adjust dose as required
On- Treatment
Samples to send to Birmingham
• BLOOD clotted 12-20mls (2x red topped tubes)
• BLOOD EDTA 4mls (1x purple topped tubes)
• Random Urine sample 20mls (Universal Supplied)
Samples to send to St Georges
• Nasal and stool sample to be taken with
equipment supplied
Week 8 (+/- 2 weeks) – Appointment 3
• Locally: FBC, U+E, creatinine (eGFR), calcium, Igs, serum +/- urine paraprotein quantitation, +/- SFLC
• Clinical and performance status assessment inc. weight
•Assessment for infections, adverse events, myeloma response, compliance, supportive care given, chemotherapy
given & QOL
• Review diary for case report form (CRF) translation (please post diary to TEAMM trial office)
• Supply patient with new diary, stool sampling kit and universal bottle for urine sample
• Review eGRF and adjust dose as required
Samples to send to Birmingham
• BLOOD clotted 12-20mls (2x red topped tubes)
• BLOOD EDTA 4mls (1x purple topped tubes)
• Random Urine sample 20mls (Universal Supplied)
Samples to send to St Georges
• Nasal and stool sample to be taken with
equipment supplied
Week 12 – Appointment 4
• Locally: FBC, U+E, creatinine (eGFR), calcium, Igs, serum +/- urine paraprotein quantitation, +/- SFLC
• Clinical and performance status assessment inc. weight
•Assessment for infections, adverse events, myeloma response, compliance, supportive care given, chemotherapy
given & QOL
• Review diary for case report form (CRF) translation (please post diary to TEAMM trial office)
• Supply patient with Post-treatment diary, stool sampling kit and universal bottle for urine sample
Samples to send to Birmingham
• BLOOD clotted 12-20mls (2x red topped tubes)
• BLOOD EDTA 4mls (1x purple topped tubes)
• Random Urine sample 20mls (Universal Supplied)
Samples to send to St Georges
• Nasal and stool sample to be taken with
equipment supplied
Follow-up
Trial drug treatment ends
Please return any unused drug to
pharmacy
Week 16 – Appointment 5
• Locally: FBC, U+E, creatinine (eGFR), calcium, Igs, serum +/- urine paraprotein quantitation, +/- SFLC
• Clinical and performance status assessment inc. Weight
•Assessment of QOL & review Post-treatment diary for case report form (CRF) translation (please post diary to TEAMM
trial office)
Samples to send to Birmingham
• BLOOD clotted 12-20mls (2x red topped tubes)
• BLOOD EDTA 8mls (1x purple topped tubes)
• Random Urine sample 20mls (Universal Supplied)
Samples to send to St Georges
• Nasal and stool sample to be taken with
equipment supplied
12 month Follow-up
• Locally: FBC, U+E, creatinine (eGFR)
• Clinical and performance status assessment inc. Weight
• Samples will be sent to Birmingham as before, no samples to St Georges at this timepoint
The details on this card are taken from Version 3.0 of the TEAMM Protocol. For more detailed information always refer to the current protocol.