FDA Approval Status of the Matterhorn Regimen
The "Matterhorn regimen" is not an FDA-approved term or specific regimen designation, but the combination of daratumumab, bortezomib, and dexamethasone (D-Vd) is FDA-approved for multiple myeloma patients who have received at least one prior therapy. 1
FDA-Approved Daratumumab Combinations
The FDA has approved daratumumab in combination with bortezomib and dexamethasone specifically for:
- Patients who have received at least one prior therapy 1
- This approval is based on the CASTOR trial, which demonstrated superior outcomes compared to bortezomib and dexamethasone alone 2
Clinical Evidence Supporting D-Vd
The combination shows exceptional efficacy with a median progression-free survival of 16.7 months versus 7.1 months for bortezomib-dexamethasone alone (HR 0.31, P<0.0001). 3
Key efficacy outcomes include:
- Overall response rate of 82.9% versus 63.2% (P<0.001) 2
- 12-month progression-free survival rate of 60.7% versus 26.9% (HR 0.39, P<0.001) 2
- Greatest benefit in first relapse patients with median PFS not reached versus 7.9 months (HR 0.19, P<0.0001) 3
- Complete response or better rate of 19.2% versus 9.0% (P=0.001) 2
Guideline Recommendations
NCCN guidelines categorize daratumumab/bortezomib/dexamethasone as a Category 1 preferred regimen for relapsed/refractory multiple myeloma after one or more prior therapies. 4
The regimen is positioned as:
- Preferred option for first relapse in bortezomib-sensitive patients 4
- Effective across clinically relevant subgroups including lenalidomide-refractory disease 3
- Superior outcomes regardless of prior treatment exposure (bortezomib, thalidomide, or lenalidomide) 3
Safety Profile
Common adverse events requiring monitoring include:
- Thrombocytopenia (45.3% grade 3/4) 2
- Infusion-related reactions (45.3%, mostly grade 1-2, occurring primarily during first infusion) 2
- Neutropenia (12.8% grade 3/4) 2
- Anemia (14.4% grade 3/4) 2
Infusion reactions can be managed with premedication and occur in 98.2% of cases during the first infusion only. 2
Important Clarification
If "Matterhorn" refers to a specific clinical trial or institutional protocol name, this is not standard nomenclature recognized by the FDA. The FDA approval specifically covers "daratumumab in combination with bortezomib and dexamethasone" without reference to trial-specific naming conventions. 1