What is the recommended initial treatment regimen for multiple myeloma?

From the Guidelines

The recommended initial treatment regimen for multiple myeloma is a three-drug combination including a proteasome inhibitor, an immunomodulatory drug, and a corticosteroid, with bortezomib, lenalidomide, and dexamethasone being a commonly used regimen, as supported by the NCCN guidelines 1.

Key Components of the Regimen

• Bortezomib: a proteasome inhibitor that prevents protein degradation leading to cell death
• Lenalidomide: an immunomodulatory drug that enhances immune response against cancer cells
• Dexamethasone: a corticosteroid that reduces inflammation and has direct anti-myeloma effects

Treatment Duration and Adjustments

• Treatment usually continues for 8-12 cycles before maintenance therapy
• Dose adjustments are necessary for patients with renal impairment, particularly for lenalidomide
• Supportive care should include bisphosphonates, prophylaxis against infections, and thromboprophylaxis when using immunomodulatory drugs

Patient Eligibility for Transplantation

• Transplant-eligible patients (typically those under 70-75 years without significant comorbidities) should undergo autologous stem cell transplantation after induction therapy
• Transplant-ineligible patients may continue treatment for a longer duration

Evidence-Based Recommendations

• The NCCN guidelines recommend using bortezomib-containing regimens as initial treatment for multiple myeloma, with or without renal impairment 1
• The European Myeloma Network recommends a triple combination of bortezomib, with either adriamycin or thalidomide and dexamethasone, or with cyclophosphamide and dexamethasone as induction therapy 1
• The Mayo Clinic Proceedings recommend using bortezomib-lenalidomide-dexamethasone as initial treatment for high-risk patients with multiple myeloma 1

From the FDA Drug Label

Table 12: Summary of Efficacy Analyses in the Relapsed Multiple Myeloma Study Time to Progression Events n (%)147 (44)196 (58)55 (42)64 (54)92 (46)132 (61) Median a (95% CI)6.2 mo(4.9,6.9)3.5 mo(2.9,4.2)7 mo(6.2,8.8)5.6 mo(3.4,6.3)4.9 mo(4. 2,6.3)2.9 mo(2.8,3.5) Hazard ratio b (95% CI)0.55(0.44,0.69)0.55(0.38,0.81)0.54(0.41,0.72) p-value c<0.00010.0019<0.0001

The recommended initial treatment regimen for multiple myeloma is not directly stated in the provided drug label. The label discusses the efficacy of bortezomib in relapsed multiple myeloma, but does not provide information on initial treatment regimens.

• Key points:
  • Bortezomib is effective in relapsed multiple myeloma.
  • The label does not provide information on initial treatment regimens.
• The FDA drug label does not answer the question.

From the Research

Initial Treatment Regimen for Multiple Myeloma

The recommended initial treatment regimen for multiple myeloma involves various combinations of drugs, including immunomodulatory agents, proteasome inhibitors, and corticosteroids.

• The BiRD regimen, which consists of clarithromycin, lenalidomide, and dexamethasone, has been shown to be effective in treatment-naive symptomatic multiple myeloma, with an objective response rate of 90.3% 2.
• Lenalidomide plus dexamethasone is another combination that has been widely used, with a high overall response rate and manageable side effects 3, 4.
• The choice of initial treatment regimen depends on various factors, including patient age, performance status, and cytogenetic profile.

Treatment Options

Some of the treatment options for multiple myeloma include:

• Lenalidomide and dexamethasone (Rev/Dex) 4
• Bendamustine, low-dose dexamethasone, and lenalidomide (BdL) 5
• Bortezomib, lenalidomide, and dexamethasone 6
• Clarithromycin, lenalidomide, and dexamethasone (BiRD) 2

Efficacy and Safety

These regimens have been shown to be effective in achieving high response rates and improving survival outcomes in patients with multiple myeloma.

• The BiRD regimen achieved a combined stringent and conventional complete response rate of 38.9% and a median progression-free survival of 22.2 months 2.
• The Rev/Dex regimen achieved an overall response rate of 91% and a complete response rate of 6% 4.
• The BdL regimen achieved an overall response rate of 47% and a median progression-free survival of 10 months 5.
• The bortezomib, lenalidomide, and dexamethasone regimen was well tolerated and showed promise as a regimen for patients with relapsed or refractory multiple myeloma 6.