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Home > PCN MM Relapsed - daratumumab [subcut], bortezomib and dexamethasone [Q3W] followed by daratumumab [subcut] [Q4W]

PCN MM Relapsed - daratumumab [subcut], bortezomib and dexamethasone [Q3W] followed by daratumumab [subcut] [Q4W]

Treatment Overview

Cycle 1 - 21 days - daratumumab [subcut], bortezomib and dexamethasone [Q3W]

Cycle length:
21

Bortezomib is ONLY to be administered subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.


Dexamethasone dose: Consider dose reduction of dexamethasone to 20 mg orally ONCE a week for patients over 75 years, BMI less than 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy. For patients on a reduced dexamethasone dose, the entire 20 mg dose was given as pre-injection medication. 


In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g., inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycles 2 to 3 - 21 days - daratumumab [subcut], bortezomib and dexamethasone [Q3W]

Cycle length:
21

Bortezomib is ONLY to be administered subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.


Dexamethasone dose: Consider dose reduction of dexamethasone to 20 mg orally ONCE a week for patients over 75 years, BMI less than 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy. For patients on a reduced dexamethasone dose, the entire 20 mg dose was given as pre-injection medication. 


In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g., inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycles 4 to 8 - 21 days - daratumumab [subcut], bortezomib and dexamethasone [Q3W]

Cycle length:
21

Bortezomib is ONLY to be administered subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.


Dexamethasone dose: Consider dose reduction of dexamethasone to 20 mg orally ONCE a week for patients over 75 years, BMI less than 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy. For patients on a reduced dexamethasone dose, the entire 20 mg dose was given as pre-injection medication. 


In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g., inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycle 9 (and all further cycles) - 28 days - daratumumab [subcut][Q4W] maintenance

Cycle length:
28

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g., inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycle details

Cycle 1 - 21 days - daratumumab [subcut], bortezomib and dexamethasone [Q3W]

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1, 8, 15
loratadine * 10 mg oral administration 1, 8, 15
dexamethasone 20 mg flat dosing oral administration 1, 2, 8,
9, 15, 16
montelukast * 10 mg oral administration 1, 8, 15
daratumumab 1800 mg flat dosing subcutaneous injection 1, 8, 15
bortezomib * 1.5 mg/m² subcutaneous injection 1, 8, 15

Bortezomib is ONLY to be administered subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.


Dexamethasone dose: Consider dose reduction of dexamethasone to 20 mg orally ONCE a week for patients over 75 years, BMI less than 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy. For patients on a reduced dexamethasone dose, the entire 20 mg dose was given as pre-injection medication. 


In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g., inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycles 2 to 3 - 21 days - daratumumab [subcut], bortezomib and dexamethasone [Q3W]

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1, 8, 15
loratadine * 10 mg oral administration 1, 8, 15
dexamethasone 20 mg flat dosing oral administration 1, 2, 8,
9, 15, 16
daratumumab 1800 mg flat dosing subcutaneous injection 1, 8, 15
bortezomib * 1.5 mg/m² subcutaneous injection 1, 8, 15

Bortezomib is ONLY to be administered subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.


Dexamethasone dose: Consider dose reduction of dexamethasone to 20 mg orally ONCE a week for patients over 75 years, BMI less than 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy. For patients on a reduced dexamethasone dose, the entire 20 mg dose was given as pre-injection medication. 


In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g., inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycles 4 to 8 - 21 days - daratumumab [subcut], bortezomib and dexamethasone [Q3W]

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1
loratadine * 10 mg oral administration 1
dexamethasone 20 mg flat dosing oral administration 1, 2, 8,
9, 15, 16
daratumumab 1800 mg flat dosing subcutaneous injection 1
bortezomib * 1.5 mg/m² subcutaneous injection 1, 8, 15

Bortezomib is ONLY to be administered subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.


Dexamethasone dose: Consider dose reduction of dexamethasone to 20 mg orally ONCE a week for patients over 75 years, BMI less than 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy. For patients on a reduced dexamethasone dose, the entire 20 mg dose was given as pre-injection medication. 


In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g., inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycle 9 (and all further cycles) - 28 days - daratumumab [subcut][Q4W] maintenance

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1
loratadine * 10 mg oral administration 1
dexamethasone 12 mg flat dosing oral administration 1
daratumumab 1800 mg flat dosing subcutaneous injection 1
dexamethasone * 4 mg flat dosing oral administration 2, 3

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g., inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Full details

Cycle 1 - 21 days - daratumumab [subcut], bortezomib and dexamethasone [Q3W]

Day: 1

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

ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:

ONE to THREE hours prior to daratumumab.
dexamethasone 20 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
montelukast * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab as per institutional policy.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:
bortezomib * 1.5 mg/m² subcutaneous injection
Instructions:

ONLY administer subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.

Day: 2

Medication Dose Route Max duration Details
dexamethasone 20 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Dose may be omitted for patients > 75 years, BMI < 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.

Day: 8

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

ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:

ONE to THREE hours prior to daratumumab.
dexamethasone 20 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
montelukast * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab as per institutional policy.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:
bortezomib * 1.5 mg/m² subcutaneous injection
Instructions:

ONLY administer subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.

Day: 9

Medication Dose Route Max duration Details
dexamethasone 20 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Dose may be omitted for patients > 75 years, BMI < 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.

Day: 15

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

ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:

ONE to THREE hours prior to daratumumab.
dexamethasone 20 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
montelukast * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab as per institutional policy.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:
bortezomib * 1.5 mg/m² subcutaneous injection
Instructions:

ONLY administer subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.

Day: 16

Medication Dose Route Max duration Details
dexamethasone 20 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Dose may be omitted for patients > 75 years, BMI < 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.

Cycles 2 to 3 - 21 days - daratumumab [subcut], bortezomib and dexamethasone [Q3W]

Day: 1

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

ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:

ONE to THREE hours prior to daratumumab.
dexamethasone 20 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:
bortezomib * 1.5 mg/m² subcutaneous injection
Instructions:

ONLY administer subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.

Day: 2

Medication Dose Route Max duration Details
dexamethasone 20 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Dose may be omitted for patients > 75 years, BMI < 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.

Day: 8

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

ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:

ONE to THREE hours prior to daratumumab.
dexamethasone 20 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:
bortezomib * 1.5 mg/m² subcutaneous injection
Instructions:

ONLY administer subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.

Day: 9

Medication Dose Route Max duration Details
dexamethasone 20 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Dose may be omitted for patients > 75 years, BMI < 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.

Day: 15

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

ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:

ONE to THREE hours prior to daratumumab.
dexamethasone 20 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:
bortezomib * 1.5 mg/m² subcutaneous injection
Instructions:

ONLY administer subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.

Day: 16

Medication Dose Route Max duration Details
dexamethasone 20 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Dose may be omitted for patients > 75 years, BMI < 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.

Cycles 4 to 8 - 21 days - daratumumab [subcut], bortezomib and dexamethasone [Q3W]

Day: 1

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

ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:

ONE to THREE hours prior to daratumumab.
dexamethasone 20 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:
bortezomib * 1.5 mg/m² subcutaneous injection
Instructions:

ONLY administer subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.

Day: 2

Medication Dose Route Max duration Details
dexamethasone 20 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Dose may be omitted for patients > 75 years, BMI < 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.

Day: 8

Medication Dose Route Max duration Details
dexamethasone 20 mg flat dosing oral administration
Instructions:

Take in the morning with food.
bortezomib * 1.5 mg/m² subcutaneous injection
Instructions:

ONLY administer subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.

Day: 9

Medication Dose Route Max duration Details
dexamethasone 20 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Dose may be omitted for patients > 75 years, BMI < 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.

Day: 15

Medication Dose Route Max duration Details
dexamethasone 20 mg flat dosing oral administration
Instructions:

Take in the morning with food.
bortezomib * 1.5 mg/m² subcutaneous injection
Instructions:

ONLY administer subcutaneously or intravenously as per protocol. Other routes of administration may be fatal.

Day: 16

Medication Dose Route Max duration Details
dexamethasone 20 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Dose may be omitted for patients > 75 years, BMI < 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.

Cycle 9 (and all further cycles) - 28 days - daratumumab [subcut][Q4W] maintenance

Day: 1

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

ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:

ONE to THREE hours prior to daratumumab.
dexamethasone 12 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Additional details

Section 1: Patients with COPD

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g., inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Supportive Care Factors

Factor Value
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Emetogenicity: Minimal
Gastroprotection: Variable
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Variable
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis may be considered

Anti CD-38 monoclonal antibody red cell phenotyping and red blood cell antibody screen: Mandatory before starting treatment.

Antiviral prophylaxis for hepatitis B virus: Guidance is limited to high-risk anti-cancer medicines. Clinicians will need to assess individual patient risk for other anti-cancer medicines.

Gastroprotection: Consider during cycles 1 to 8.

PJP prophylaxis: Recommended during cycles 1 to 8. Consider during daratumumab maintenance (cycles 9 onwards).

References

Quach, H., S. Benson, H. Haysom, et al. 2018. "Considerations for pre-transfusion immunohaematology testing in patients receiving the anti-CD38 monoclonal antibody daratumumab for the treatment of multiple myeloma." Intern Med J 48(2):210-220., PMID: 29415351

Palumbo, A., A. Chanan-Khan, K. Weisel, et al. 2016. "Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma." N Engl J Med 375(8):754-766., PMID: 27557302

Mateos, M. V., P. Sonneveld, V. Hungria, et al. 2020. "Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma: Three-year Follow-up of CASTOR." Clin Lymphoma Myeloma Leuk 20(8): 509-518., PMID: 32482541

Weisel, K. C., P. Sonneveld, M.V. Mateos, et al. 2019. "Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone (D-Vd) Versus Bortezomib and Dexamethasone (Vd) in First Relapse Patients (pts) with Multiple Myeloma (MM): Four-Year Update of Castor." Blood 134(Supplement_1): 3192.

Weisel, K., A. Spencer, S. Lentzsch, et al. 2020. "Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk." J Hematol Oncol 13(1):115., PMID: 32819447

Abousaud, M., E. Dressler, J. Duda, et al. 2019. "Efficacy and safety of a modified daratumumab/bortezomib/dexamethasone regimen using once weekly bortezomib in relapsed refractory multiple myeloma." Clin Lymphoma Myeloma Leuk 19(10): e150-e151.

Juno Pharmaceuticals NZ Ltd. Bortezomib JUNO New Zealand medicine datasheet 6 April 2020 https://www.medsafe.govt.nz/profs/datasheet/b/bortezomibjunoinj.pdf (Accessed 31 March 2022).

Janssen-Cilag (New Zealand) Ltd Daralex SC New Zealand Medicine Datasheet 27 May 2021 https://www.medsafe.govt.nz/profs/datasheet/d/darzalexscinj.pdf (Accessed 4 April 2022).

Regimen details sometimes vary slightly from the published literature after recommendation by expert committee consensus.

* 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.