Patient Inclusion Follow-up Request Form – Medical Need Program for Individual Patient Supply of Levact® (bendamustine hydrochloride)
Patient’s identification: Physician’s name: internal use only:
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In order to comply with regulatory requirements, Mundipharma Comm. VA needs to obtain the following information before being able to process your request for drug supply in the Medical Need Program for Individual Patient Supply of Levact® (bendamustine hydrochloride).
May we kindly request you to fax the next pages accurately completed and signed to Fax: +32 15 45 11 90
Follow-up Request Form
Follow-up Request Form Medical Need Program for Levact® Final 12 January 2012 1/5 Medical Need Program for Individual Patient Supply of Levact®
Patient’s identification: Physician’s name: internal use only:
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INCLUSION CRITERIA : Tick Yes or No Yes No All criteria should be fulfilled to enter a patient in the Medical Need Program Patients who are to be included in the study, are those who meet the following criteria:
(a) The patient has a symptomatic relapsed or refractory multiple myeloma
- that has progressed following therapies that included bortezomib and lenalidomide either alone or in any combination - this disease progression must have occurred within 6 months after discontinuation of the last therapy - patients that have discontinued bortezomib or lenalidomide because of severe side effects precluding their further use
(b) Written informed consent is obtained.
(c) The patient is a man or woman at least 18 years of age.
(d) The patient has a life expectancy of more than 3 months. (e) The patient has an ECOG performance status of 0, 1, or 2.
(f) The patient has an absolute neutrophil count (ANC) greater than 1 x 109/L, hemoglobin greater than 8.0 g/dL, and platelet count greater than 50 x 109/L The patient has been independent of platelet transfusion or granulocyte- colony stimulating factor (G-CSF) support for more than 1 weeks.
patients with a platelet count between 25.000 and 50.000 can be included if this thrombocytopenia is due to a massive myeloma infiltration in the bone marrow (This must be confirmed by a bone marrow aspirate showing at least 50 % of myeloma cells)
(g) The patient may have received an allogeneic and/or autologous transplant.
(h) The patient has a creatinine clearance of 10 mL/minute as measured or as calculated based on the Cockcroft-Gault method.
Follow-up Request Form Medical Need Program for Levact® Final 12 January 2012 Medical Need Program for Individual Patient Supply of Levact®
Patient’s identification: Physician’s name: internal use only:
......
EXCLUSION CRITERIA : Tick Yes or No Yes No Patients who are to be excluded from the study are those who meet any of the following criteria:
(a) The patient with a asymptomatic disease progression .
(b) The patient has plasma cell leukemia.
(c) The patient received prior treatment with Levact®.
(d) The patient has any serious psychiatric or medical condition that could interfere with treatment or study procedures, place the patient at unacceptable risk, or confound the ability of investigators to interpret study data.
(e) Patients requiring dialysis.
(f) Patients showing moderate or severe liver dysfunction. (serum bilirubin total bilirubin ≥ 1.5 x ULN , and direct bilirubin ≥ 2.0 mg/dL and AST or ALT ≥ 2 x ULN). (g) Any history of hypersensitivity to the active substance or to any of the excipients.
(h) Patients with jaundice.
(i) Patients who received major surgery less than 30 days before start of treatment.
(j) Patients with infections, especially involving leukocytopenia.
(k) Patients who had yellow fever vaccination.
(l) No patient signed informed consent.
(m) Pregnancy or lactation.
(n) Patient is eligible for doxorubicin treatment.
Written informed consent obtained
Follow-up Request Form Medical Need Program for Levact® Final 12 January 2012 Medical Need Program for Individual Patient Supply of Levact®
Patient’s identification: Physician’s name: internal use only:
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Confirmation of Acceptance of the terms:
(a) You will use the medication only for the patient specified, using doses as specified in the Medical Need Program protocol (see SPC).
(b) You will consider reporting safety events as per guidance on safety reporting.
(c) You will maintain records of all patients having received supplies.
(d) You will inform Mundipharma Comm. VA when your patient has stopped/finished Medical Need Program treatment through the End of treatment form provided.
(e) You will return all unused medication to Mundipharma Comm. VA/or you will send all unused medication to your hospital pharmacy for destruction. By no means can the supply for this patient be given to another patient.
(f) Herewith you confirm having informed the patient and having obtained the patient’s acceptance through the written informed consent form.
(g) You agree that Mundipharma Comm. VA may collect and process your personal data in accordance with the law on the privacy.
(h) You agree to keep all Medical Need Program documentation for 10 years.
Amount of drug requested:
Drug delivery to
Requesting physician: Hospital Pharmacist:
Name ...... Address ...... Telephone ...... Fax ......
Follow-up Request Form Medical Need Program for Levact® Final 12 January 2012 Medical Need Program for Individual Patient Supply of Levact®
Patient’s identification: Physician’s name: internal use only:
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I agree with the conditions set out above.
Physician’s signature: ……………………………………… Date: …... / ……. / 20……
Physician’s Name ......
Address ......
......
Telephone ......
Fax ......
E-mail (mandatory) ......
Email contact person (if applicable) ......
Approved by Mundipharma Comm. VA responsible physician
Amount of drug approved:…….
Date: ….. / ….. / 20….. Signature:
For further medical information, please call Dr. Michaël Magagnin on +32 479 70 30 24 For further information on drug delivery, please call Dr. Michaël Magagnin on +32 479 70 30 24
Follow-up Request Form Medical Need Program for Levact® Final 12 January 2012