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Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.

BORTDEXALENA+DARA; LENA+DARA(MNT)

Cancer Type:
Hematologic, 
Multiple Myeloma
Intent: Palliative
Regimen Category: Evidence-informed
Funding:
New Drug Funding Program
    Bortezomib - Previously Untreated - Multiple Myeloma Pre-Stem Cell Transplant
ODB - General Benefit
    dexamethasone
A - Regimen Name

BORTDEXALENA+DARA Regimen
Bortezomib-Dexamethasone-Lenalidomide-Daratumumab
LENA+DARA(MNT) Regimen
Lenalidomide-Daratumumab (maintenance)


Disease Site
Hematologic
Multiple Myeloma


Intent
Palliative

Regimen Category
Evidence-informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully  improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.

This Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.


Rationale and Uses

Treatment of newly diagnosed multiple myeloma in transplant-eligible patients


Supplementary Public Funding

bortezomib
New Drug Funding Program (Bortezomib - Previously Untreated - Multiple Myeloma Pre-Stem Cell Transplant) (NDFP Website )

dexamethasone
ODB - General Benefit (dexamethasone) (ODB Formulary)

 
B - Drug Regimen

Cycles 1 to 4 (Pre-transplant induction):

daratumumab
16 mg /kg IV Days 1, 8, 15
(This drug is not currently publicly funded for this regimen and intent)
bortezomib
1.3 mg /m² IV / Subcut Days 1, 4, 8, 11
lenalidomide
25 mg PO Days 1 to 14
(This drug is not currently publicly funded for this regimen and intent)
dexamethasone

1

20 mg IV / PO Days 1, 2, 8, 9, 15, and 16

 

Cycles 5 to 6 (Post-transplant consolidation):

daratumumab
16 mg /kg IV Day 1
(This drug is not currently publicly funded for this regimen and intent)
bortezomib
1.3 mg /m² IV / Subcut Days 1, 4, 8, 11
lenalidomide
25 mg PO Days 1 to 14
(This drug is not currently publicly funded for this regimen and intent)
dexamethasone

1

20 mg IV / PO Days 1, 2, 8, 9, 15, 16

 

Then,

LENA+DARA(MNT):

daratumumab
16 mg /kg IV Day 1
(This drug is not currently publicly funded for this regimen and intent)
lenalidomide

2

10 mg PO Days 1 to 21
(This drug is not currently publicly funded for this regimen and intent)

Lenalidomide may only be prescribed and dispensed by physicians and pharmacists registered with a controlled distribution program. Patients must also be registered and meet all conditions of the program.

In elderly patients, the dexamethasone dose should be reduced (i.e. to 20 mg once weekly).

2 May increase lenalidomide to 15 mg after 3 cycles

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C - Cycle Frequency

REPEAT EVERY 28 DAYS

For 4 induction cycles before transplant and 2 consolidation cycles post-transplant

LENA+DARA(MNT): Repeat every 28 days until disease progression or unacceptable toxicity, or up to 2 years total

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Low
No routine prophylaxis for lenalidomide

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
​​​​​​

Daratumumab pre-medications (prophylaxis for infusion reaction):

To be given at least 1 hour prior to daratumumab infusion:

  • Dexamethasone 20 mg IV/PO*
  • Oral antipyretic (e.g. acetaminophen 650-1000 mg)
  • H1-receptor antagonist IV/PO (e.g. diphenhydramine 25-50 mg or equivalent)
  • Famotidine 20 mg IV (or equivalent)
  • Montelukast 10 mg PO**

*Administer IV prior to the first infusion; Oral administration may be considered prior to subsequent infusions. Dexamethasone on the day of infusion may be given as part of pre-/post-medications for daratumumab; 20 mg IV/PO on the day of daratumumab infusion and 20 mg PO on the day after infusion. For patients receiving reduced dose dexamethasone 20 mg weekly, the entire 20 mg dose has been given prior to the daratumumab infusion in some clinical trials.

**The addition of montelukast given prior to the first infusion numerically reduced the incidence of respiratory IRs in the study by Nooka et al.


Post-daratumumab infusion medications (prevention of delayed reactions):

  • Dexamethasone 20 mg PO on the day after daratumumab infusion* 
  • Consider bronchodilators (e.g. short and long acting) and inhaled corticosteroids if chronic obstructive pulmonary disorder&****

*Dexamethasone on the day of infusion may be given as part of pre-/post-medications for daratumumab; 20 mg IV/PO on the day of daratumumab infusion and 20 mg PO on the day after infusion. For patients receiving reduced dose dexamethasone 20 mg weekly, the entire 20 mg dose has been given prior to the daratumumab infusion in some clinical trials.

&Consider adding an H1-receptor antagonist if the patient is at higher risk of respiratory complications.

***These may be discontinued after the 4th infusion if no major IRs occurred.
 

Other Supportive Care:

  • HBV screening should be performed in all patients prior to starting daratumumab.

  • Daratumumab can interfere with cross-matching for blood transfusions; type and screen and RBC genotyping tests should be done before starting this drug.

  • Antiviral prophylaxis for herpes zoster is recommended.

  • Patients at risk of tumour lysis syndrome should have appropriate prophylaxis and be monitored closely.

  • For lenalidomide, prophylaxis for venous thromboembolism is recommended in patients at risk (e.g. low dose aspirin 81-100 mg PO daily or enoxaparin 40 mg SC daily).

  • Careful consideration and monitoring must be taken with erythropoietin stimulating agents (ESAs), since the concomitant use of ESAs with lenalidomide may potentiate the risk of thrombosis.  RBC or platelet transfusions with lenalidomide dose reductions/interruptions may be appropriate in severe / symptomatic anemia or thrombocytopenia.

  • Consider GCSF as secondary prophylaxis.

  • Optimal control of thyroid function is recommended prior to starting lenalidomide treatment.

 
J - Administrative Information

Lenalidomide, Dexamethasone: Outpatient prescription for home administration


Approximate Patient Visit
BORTDEXALENA+DARA
Bortezomib: 0.5 hours; Daratumumab: 2.5 to 7.5 hours (depending on duration of infusion)
Pharmacy Workload (average time per visit)
BORTDEXALENA+DARA
16.369 minutes
Nursing Workload (average time per visit)
BORTDEXALENA+DARA
27.5 minutes
 
K - References

Bortezomib, daratumumab and lenalidomide drug monographs. Ontario Health (Cancer Care Ontario).

Voorhees PM, Kaufman JL, Laubach J, et al. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood 2020 Aug 20;136(8):936-45. 

August 2023 new ST-QBP regimen


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.