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Systemic Anti-Cancer Therapy Regimen Library

HSCT Autologous conditioning - BEAM [carmustine, etoposide, cytarabine and melphalan] [lymphoma]

Treatment Overview

This regimen contains a medicine where one or more biosimilars may exist. Any biosimilars used have been reviewed by the regulator (Medsafe) and relevant specialists were consulted nationally. Where regulators, in consultation with relevant specialists, have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably.

Cycle 1 - 60 days

Cycle length:
60

Hydration in addition to that specified is recommended as per institutional practice and may need an individualised approach.


carmustine:

  • Dose adjustment for patients weight may be required.
  • See Dosing for bodyweight in Additional details.
  • Refer to latest literature or access https://anztct.org.au (registration required).

melphalan:

  • Consider oral cryotherapy on Day -1 by giving patient ice to suck starting 15 minutes prior to, during and up to one hour after the melphalan infusion.
  • The total time from preparation to the completion of the infusion should not exceed 90 minutes.

filgrastim: Give filgrastim 5 microgram/kg subcutaneously ONCE daily from Day 5 until engraftment.

Cycle details

Cycle 1 - 60 days

Medication / Procedure Dose Route Days Max Duration
carmustine * 300 mg/m² intravenous -6 180 minutes Min: 100 minutes
etoposide (as phosphate) * 200 mg/m² Once daily intravenous -5 to -2 15 minutes
cytarabine * 200 mg/m² Twice daily intravenous -5 to -2 60 minutes
sodium chloride 0.9 % intravenous -1 120 minutes
melphalan 140 mg/m² intravenous -1 20 minutes
sodium chloride 0.9 % intravenous -1 120 minutes
paracetamol * 1000 mg flat dosing oral administration 0
proMETHazine * 12.5 mg intravenous 0 1 minutes
Autologous stem cell transplant intravenous 0
filgrastim 5 microgram/kg Once daily subcutaneous injection 5

Hydration in addition to that specified is recommended as per institutional practice and may need an individualised approach.


carmustine:

  • Dose adjustment for patients weight may be required.
  • See Dosing for bodyweight in Additional details.
  • Refer to latest literature or access https://anztct.org.au (registration required).

melphalan:

  • Consider oral cryotherapy on Day -1 by giving patient ice to suck starting 15 minutes prior to, during and up to one hour after the melphalan infusion.
  • The total time from preparation to the completion of the infusion should not exceed 90 minutes.

filgrastim: Give filgrastim 5 microgram/kg subcutaneously ONCE daily from Day 5 until engraftment.

Full details

Cycle 1 - 60 days

Day: -6

Medication Dose Route Max duration Details
carmustine * 300 mg/m² intravenous 180 minutes Min: 100 minutes
Instructions:
  • Dose adjustment for patients weight may be required, see Dosing for bodyweight, below.
  • Do not exceed an infusion rate of 3 mg/m2 per minute.
  • Prepare solution in PVC-free bag and administer via polyethylene lined administration set.
  • Protect bag and administration line from light.
Additional details:

Day: -5

Medication Dose Route Max duration Details
etoposide (as phosphate) * 200 mg/m² Once daily intravenous 15 minutes Additional details:
cytarabine * 200 mg/m² Twice daily intravenous 60 minutes
Instructions:

Every 12 hours.

Additional details:

Day: -4

Medication Dose Route Max duration Details
etoposide (as phosphate) * 200 mg/m² Once daily intravenous 15 minutes Additional details:
cytarabine * 200 mg/m² Twice daily intravenous 60 minutes
Instructions:

Every 12 hours.

Additional details:

Day: -3

Medication Dose Route Max duration Details
etoposide (as phosphate) * 200 mg/m² Once daily intravenous 15 minutes Additional details:
cytarabine * 200 mg/m² Twice daily intravenous 60 minutes
Instructions:

Every 12 hours.

Additional details:

Day: -2

Medication Dose Route Max duration Details
etoposide (as phosphate) * 200 mg/m² Once daily intravenous 15 minutes Additional details:
cytarabine * 200 mg/m² Twice daily intravenous 60 minutes
Instructions:

Every 12 hours.

Additional details:

Day: -1

Medication Dose Route Max duration Details
sodium chloride 0.9 % intravenous 120 minutes
Quantity:1000 mL
Instructions:

Prior to melphalan infusion.

melphalan 140 mg/m² intravenous 20 minutes
Instructions:
  • Consider oral cryotherapy by giving patient ice to suck starting 15 minutes prior to, during and up to one hour after the melphalan infusion.
  • The total time from preparation to the completion of the infusion should not exceed 90 minutes.
Additional details:
sodium chloride 0.9 % intravenous 120 minutes
Quantity:1000 mL
Instructions:

After melphalan infusion.

Day: 0

Medication / Procedure Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:

ONE hour prior to return of autologous stem cells, or as per institutional practice.

proMETHazine * 12.5 mg intravenous 1 minutes
Instructions:

ONE hour prior to return of autologous stem cells, or as per institutional practice.

Autologous stem cell transplant intravenous
Instructions:

Administer as per institutional practice, at least 24 hours after melphalan infusion completed.

Day: 5

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Give ONCE daily from Day 5 until engraftment.

  • Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Additional details

Section 1: Dosing for bodyweight

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Routine antifungal prophylaxis recommended
Antiviral prophylaxis for hepatitis B virus: Required for anti–HBc positive patients at risk of reactivation
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Emetogenicity: Variable
Gastroprotection: Gastroprotection may be considered
Growth factor support: Recommended for primary prophylaxis
Hydration: Routine hydration recommended
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Irradiated blood components: Irradiation of blood components is recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis may be considered

Emetogenicity:

  • HIGH day -6 and day -1;
  • LOW days -5 to -2;


References

Philip, T, C Guglielmi, A Hagenbeek, et al. 1995. "Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma." New England Journal of Medicine 333(23):1540., PMID: 7477169

Buadi F. K, Micallef I. N , Ansell S. M, et al. 2006.''Autologous hematopoietic stem cell transplantation for older patients with relapsed non-Hodgkin's lymphoma'.Bone Marrow Transplantation 37 (11), 1017–1022., PMID: 16633361

Salar A, Sierra J, Gandarillas M et al. 2001"Autologous stem cell transplantation for clinically aggressive non-Hodgkin's lymphoma: the role of preparative regimens" Bone Marrow Transplant. Feb;27(4):405-12., PMID: 11313670

Chopra, R., A. K. McMillan, D. C. Linch, et al. 1993. "The place of high-dose BEAM therapy and autologous bone marrow transplantation in poor-risk Hodgkin's disease. A single-center eight-year study of 155 patients." Blood. 81(5):1137-1145., PMID: 8443375

Mills, W., R. Chopra, A. McMillan, et al. 1995. "BEAM chemotherapy and autologous bone marrow transplantation for patients with relapsed or refractory non-Hodgkin's lymphoma." J Clin Oncol 13(3):588-595., PMID: 7884420

Linch, DC, AH Goldstone, A McMillan, et al 1993. "Dose intensification with autologous bone-marrow transplantation in relapsed and resistant Hodgkin's disease: results of a BNLI randomised trial." The Lancet 341(8852):1051-1054., PMID: 8096958

William, B. M., F. R. Loberiza, Jr., V. Whalen, et al. 2013. "Impact of conditioning regimen on outcome of 2-year disease-free survivors of autologous stem cell transplantation for Hodgkin lymphoma." Clin Lymphoma Myeloma Leuk 13(4):417-423., PMID: 23773453

Schmitz, N., B. Pfistner, M. Sextro, et al. 2002. "Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease: a randomised trial." Lancet 359(9323):2065-2071., PMID: 12086759

Puig, N., De La Rubia, J., Remigia M, et al. 2006. "Morbidity and transplant-related mortality of CBV and BEAM preparative regimens for patients with lymphoid malignancies undergoing autologous stem-cell transplantation." Leukemia and Lymphoma. Aug;47(8):1488-94., PMID: 16966258

Apperley J, Carreras E, Gluckman E, et al. Haematopoietic Stem Cell Transplantation: The ESH-EBMT Handbook. Fifth Edition. Forum Service Editore, Genoa.

Bubalo J, Carpenter PA, et al; American Society for Blood and Marrow Transplantation practice guideline committee. Conditioning chemotherapy dose adjustment in obese patients: a review and position statement by the American Society for Blood and Marrow Transplantation practice guideline committee. Biol Blood Marrow Transplant. 2014 May;20(5):600-16. doi: 10.1016/j.bbmt.2014.01.019. Epub 2014 Jan 23., PMID: 24462742

Emcure NZ Limited BiCNU New Zealand Datasheet 29 April 2020 https://www.medsafe.govt.nz/profs/datasheet/b/bicnuinj.pdf Acessed 25 May 2022).

Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142., PMID: 28848668

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14., PMID: 29443651

New Zealand Blood Service Transfusion Medicine Handbook Third Edition, 2016 https://www.nzblood.co.nz/assets/Transfusion-Medicine/PDFs/111G122.pdf (accessed 16 June 2022).

Doyle J, Raggatt M, Slavin M, McLachlan SA, Strasser SI, Sasadeusz JJ, Howell J, Hajkowicz K, Nandurkar H, Johnston A, Bak N, Thompson AJ. Hepatitis B management during immunosuppression for haematological and solid organ malignancies: an Australian consensus statement. Med J Aust. 2019 Jun;210(10):462-468. doi: 10.5694/mja2.50160. Epub 2019 May 19., PMID: 31104328

Nakagaki M, Button E, Keating A, Marsh J, Mitchell C, Birchley A, Kennedy GA. Hyperhydration is not necessary for high-dose melphalan in stem cell transplantation. Bone Marrow Transplant. 2020 Apr;55(4):827-829. doi: 10.1038/s41409-019-0586-1. Epub 2019 Jun 11., PMID: 31186515

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.