LEVACT Medical Supply Program

FAX/E-Mail this signed form to

the BHS Decision Committee(J Caers, I VandeBroek, MC Vekemans)

Jo Caers () fax nr 04/366 88 55

Marie Christiane Vekemans () fax nr02/764.89.59

Isabelle Vande Broek () fax nr03/7602376

Center: ………………………………………………………………………………………………………………………………
Physician: ……………………Tel:…………………..Fax:……………………. E-mail:………………………………….
Address: ...... Postcode:…………….. City:…………………………….
Pharmacist: ...... Tel:...... Fax:......
Patient initials: / …..(First name) / ….. (Last name) / Gender: Male Female
Date of birth: / …..(Day) / …..(Mo) / ………. (Year) / Age: …….. yrs Weight:……. Kg Length: ……. Cm
Request for LEVACT
MM disease in relapse after earlier treatment with Bortezomib and Lenalidomide.
I will complete a small CRF reporting on the outcome of this patient
Dosing for LEVACT
Dose asked: ……… mg/m² x …….. body surface= …….. mg X 2 (day 1, 2)= ……….. mg
Study Medication / Unit Strength / Dosing frequency / Mode of Administration
Bendamustine hydrochloride (Levact®) / 70-100 mg/m² / day 1 and 2, every 4 weeks* / Intravenous
* average of 4 treatment cycles per patient. In general, there is no limitation in the number of cycles. If the patient responds and has no major toxicity, treatment can be continued.
Documentation of MM disease (please join a recent consultation report)
Date of onset of MM diagnosis: …..(Day) / …..(Mo) / ………. (Year)
Isotype IgA IgG Light chain Other: …………..
Treatmentgiven: Drugs + dose Start on Stop on Response
………………………………..……… .…../……/20…… .…../……/20…… …………………………………..
………………………………..……… .…../……/20…… .…../……/20…… …………………………………..
………………………………..……… .…../……/20…… .…../……/20…… …………………………………..
………………………………..……… .…../……/20…… .…../……/20…… …………………………………..
………………………………..……… .…../……/20…… .…../……/20…… …………………………………..
………………………………..……… .…../……/20…… .…../……/20…… …………………………………..
This treatment included Bortezomib
Lenalidomide
Last treatment was within 6 months Yes No
Progression is symptomatic Yes No
Evidence of Plasma cell leukemia Yes No
The patient received prior treatment with bendamustine Yes No
Patient is eligible for doxorubicin treatment Yes No
Co-morbidity
Presence of renal failure. Yes No
Please specify: serum creatinine value of ..…… mg/dl
clearance of ……. mL/minute (Cockcroft-Gault method)
The patient receives dialysis Yes No
Presence of moderate or severe liver dysfunction. Yes No
(serum bilirubin ≥ 1.5 x ULN , and direct bilirubin ≥ 2.0 mg/dL
and AST or ALT ≥ 2 x ULN).
The patient has active infection. Yes No
Current Performance Score 1 2 3 4
Expected life expectancy less than 3 months Yes No
Presence of a psychiatric or medical condition that could Yes No
interfere with treatment or study procedure.
Patient signed informed consent Yes No
Patient received major surgery within 30 days before start of treatment Yes No
Patient was vaccinated for yellow fever Yes No
Patient is pregnant or lactating Yes No
Blood parameters (please join recent blood analysis)
Hg level ………g/dl (last transfusion on …………..)
Platelet level ………10 ³/µl (last platelet transfusion on ………..)
If platelet level decreased, percentage of BM infiltration by myeloma cells: ………. % (join protocol)
WBC level ……… 10 ³/µl (Neutrophils: ………………..)
Signature of requesting physician:……………………………………….…..(Day) / …..(Mo) / ………. (Year)

BHS committee decision

Request accepted

Request not accepted – reason (optional):………………………………………………………………………….

Date: _____/_____/______Name: ______Signature: ______

In order to receive samples of Levact, the requesting physician must fax :
- Copy of the request form approved by the BHS decision committee
- MUNDIPHARMA REQUEST FORM to Michaël Magagnin (Mundipharma)

Mundipharma : Fax+32 15 45 11 90

We thank you for allowing some time for handling your request:
5 working days for the BHS & 3 working days for Mundipharma

DISCLAIMER

Mundipharma and/or the members of the Decision Committee shall not be liable towards physicians and their patients for not allowing patients into this Levact off label sampling program.

Mundipharma and/or the Decision Committee Members shall be under no obligation to include the applicants into the program. Decisions are taken on strict and scientifically inclusion criteria and quotas are used.

The treating physician must inform the patient on the advantages and the disadvantages of the off label use as well as of the risks of off label use. The physician must also inform the patient that allowance to the program is not guaranteed. The physician must obtain the informed consent of the patient for off label use.

Mundipharma and/or the members of the Decision Committee shall not be liable towards the physicians and patients for any adverse or unwanted effect caused by the off label use of Levact in the treatment plan of the patients. The start of a patient in an off label use program is done on the own personal liability of the treating physician.

DO NOT FAX FROM HERE

The inclusion criteria are (all criteria must be met):

(a) The patient has a symptomatic relapsed 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 thrombopenia 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.

The Exclusion Criteria are

(a) The patient with a asymptomatic disease progression.

(b) The patient has plasma cell leukemia.

(c) The patient received prior treatment with bendamustine.

(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) Patient is eligible for doxorubicin treatment.

(h) Any history of hypersensitivity to the active substance or to any of the excipients.

(i) Patients who received major surgery less than 30 days before start of treatment.

(j) Patients with active infections, especially involving leukocytopenia.

(k) Patients who had yellow fever vaccination.

(l) No patient signed informed consent.

(m) Pregnancy or lactation.

Procedure :

  • The requesting physician fills out the “Levact Medical Supply” form with all the needed information.
  • The request form is sent to the BHS decision committee by E-mail or by fax.
  • Jo Caers04/366.88.55
  • Isabelle van de Broek03/
  • Marie-Christiane Vekemans02/764.89.59
  • Only requests for patients who meet the inclusion criteria mentioned in the form will be considered for approval.
  • The requests will be reviewed within 5 working days and should be approved by at least 2 members of the BHS decision committee. Members of the BHS decision committee cannot approve their own requests. In case of no response within 5 working days, the coordinator may take the final decision alone.
  • The committee members will sent their approval to Jo Caers who collects and transmits the decision to the requesting physician.
  • The requesting physician will then fax to Mundipharma
  • Copy of the request form approved by the BHS decision committee
  • MUNDIPHARMA REQUEST FIRST C YCLE to Michaël Magagnin (Mundipharma)
  • Mundipharma will send the samples to the pharmacist of the hospital.
  • For other cycles, the requesting physician directly contacts Mundipharma by faxing the MUNDIPHARMA REQUEST FOLLOW-UP document.

Only 2 patients can be included per centre (due to small sample size of the study)

Procedure (do not fax this page):

Bendamustine MNP-BHS request form 28/09/2018Page 1/4