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.
BMP+DARA
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.
For treatment of newly diagnosed multiple myeloma, in patients who are not suitable for autologous stem cell transplant and have good performance status
bortezomib
New Drug Funding Program
(Bortezomib - Previously Untreated - Multiple Myeloma)
(NDFP Website
)
melphalan
ODB - General Benefit
(melphalan - oral tablets)
(ODB Formulary
)
prednisone
ODB - General Benefit
(prednisone)
(ODB Formulary
)
daratumumab
New Drug Funding Program
(Daratumumab in Combination with a Bortezomib-Based Regimen for Newly Diagnosed Transplant Ineligible Multiple Myeloma)
(NDFP Website
)
Note: Different daratumumab products are NOT INTERCHANGEABLE.
Cycle 1^:
| daratumumab | 16 mg /kg | IV | Days 1*, 8, 15, 22, 29, 36 |
|
* For cycle 1 day 1, splitting the first dose over 2 days has been described (8 mg/kg days 1 and 2) and may be considered. |
|||
|
bortezomib † | 1.3 mg /m² | IV / Subcut | Days 1, 4, 8, 11, 22, 25, 29, 32 |
| melphalan | 9 mg /m² | PO | Days 1 to 4 |
| prednisone | 60 mg /m² | PO | Days 1 to 4 |
|
Cycles 2 to 9^: |
|||
| daratumumab | 16 mg /kg | IV | Days 1, 22 |
|
bortezomib † | 1.3 mg /m² | IV / Subcut | Days 1, 8, 22, 29 |
| melphalan | 9 mg /m² | PO | Days 1 to 4 |
| prednisone | 60 mg /m² | PO | Days 1 to 4 |
^Dosing based on ALCYONE trial. Other BMP schedules may be considered.
†Missed doses should not be made up. A minimum of 72 hours is required between bortezomib doses.
REPEAT EVERY 42 DAYS
For 9 cycles, unless disease progression or unacceptable toxicity
Refer to DARA(MNT) for CYCLES 10 AND BEYOND (Daratumumab monotherapy REPEAT EVERY 28 DAYS until disease progression or unacceptable toxicity)
Low
Minimal (Cycle 1, days 15 and 36)
No routine prophylaxis for melphalan PO
Other Supportive Care:
Also refer to CCO Antiemetic Recommendations.
Supportive care:
-
HBV screening should be performed in all patients prior to starting daratumumab.
-
Consider antiviral prophylaxis for herpes zoster reactivation.
-
Daratumumab can interfere with cross-matching for blood transfusions; type and screen and RBC genotyping tests should be done before starting this drug.
-
Patients at risk of tumour lysis syndrome should have appropriate prophylaxis and be monitored closely.
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. Additional regimen-specific corticosteroids (e.g., prednisone) should not be taken on injection days when dexamethasone is given as pre-medication.
**The addition of montelukast given prior to the first infusion numerically reduced the incidence of respiratory infusion reactions in the study by Nooka et al.
Post-infusion medications (prevention of delayed reactions):
- Prednisone as per BMP regimen***
- Consider bronchodilators (e.g. short and long acting) and inhaled corticosteroids (for patients with a history of COPD)&****
*** Or alternative corticosteroids (e.g. oral methylprednisolone (≤20 mg) or equivalent) the day after infusion as per physician discretion.
&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.
Bortezomib and daratumumab drug monographs. Ontario Health (Cancer Care Ontario).
Mateos MV, Cavo M, Blade J, et al. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. Lancet 2020 Jan 11;395(10218):132-41.
Nooka AK, Gleason C, Sargeant MO, et al. Managing infusion reactions to new monoclonal antibodies in multiple myeloma: daratumumab and elotuzumab. J Oncol Pract 2018 Jul;14(7):414-22.
pCODR Expert review committee final recommendation: Daratumumab for the treatment of patients with newly diagnosed multiple myeloma. Aug 29, 2019.
September 2022 Modified Drug regimen section
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.