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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.

A - Regimen Name

MELPPRED Regimen
Melphalan (oral)-Prednisone


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.


Rationale and Uses

First line treatment of patients with multiple myeloma who are not candidates for transplant.


Supplementary Public Funding

melphalan
ODB - General Benefit (melphalan - oral tablets)

prednisone
ODB - General Benefit (prednisone)

 
B - Drug Regimen

melphalan
8-9 mg /m² PO Days 1 to 4
(Outpatient prescription in multiples of 2mg tablets; taken on an empty stomach, for maximal absorption)
prednisone
100 mg PO Days 1 to 4
(Outpatient prescription in multiples of 50mg tablets)
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C - Cycle Frequency

REPEAT EVERY 28 DAYS

Until disease progression or unacceptable toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal – No routine prophylaxis; PRN recommended

Other Supportive Care:

Also refer to CCO Antiemetic Recommendations.

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.

Dosage with toxicity

See Appendix 6 for general recommendations.


Renal Impairment

Creatinine Clearance (mL/sec)
% usual dose
0.2 – 0.8
REDUCE Melphalan to 75% dose
<0.2
REDUCE Melphalan to 50% dose

 
F - Adverse Effects

Refer to melphalan, prednisone drug monograph(s) for additional details of adverse effects

 


Most frequently occurring adverse effects

  • Myelosuppression
  • Stomatitis
  • Pulmonary toxicity
  • Hyperglycemia
  • Insomnia
  • Mood changes
  • Cushingoid syndrome 
  • Muscle weakness
  • Gastric irritation – peptic ulcer
  • Fluid retention
  • Cataracts
 
G - Interactions
Refer to melphalan, prednisone drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions

Refer to melphalan, prednisone drug monograph(s) for additional details

 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • Clinical toxicity assessment (including stomatitis, gastrointestinal)
  • Routine blood glucose test.
  • Routine CBC (since absorption of melphalan is erratic, mild myelosuppression should be detected three weeks after drug administration, in order to confirm drug absorption).
  • Baseline and regular hepatic and renal function tests and urinalysis.
  • Routine pulmonary function test and clinical pulmonary exam.
  • Clinical exam for proximal muscle myopathy.
  • Baseline ophthalmologic exam for evidence of cataracts.
  • Full assessment by ophthalmologist if cataracts suspected.
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

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J - Administrative Information
Outpatient prescription for home administration

 
K - References

Bataille R, Harousseau JL. Multiple myeloma. N Engl J Med 1997;336:1657-64.

Bergsagel DE, Sprague CC, Austin C et al. Evaluation of new chemotherapeutic agents in the treatment of myeloma IV: phenylalaine mustard. Cancer Chemothera Rep 1962; 21:87.

Gregory WM, Richards MA, Malpas JS. Combination chemotherapy versus melphalan & prednisolone in the treatment of multiple myeloma: An overview of published trials. J Clin Oncol 1992;10:334-42.

Myeloma Trialists’ Collaborative Group. Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6633 patients from 27 randomized trials. J Clin Oncol 1998;16:3832-42.


June 2019 Updated emetic risk category; added PEBC guideline link


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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.