HOVON 143 (FL)

Efficacy and tolerability of ixazomib, daratumumab and low dose dexamethasone (IDd) followed by ixazomib and daratumumab maintenance therapy until progression for a maximum of 2 years in unfit and frail newly diagnosed multiple myeloma (MM) patients; an open-label phase II trial (HOVON 143)

Study treatments

• Induction therapy: 9 cycles of ixazomib (oral, 4 mg), daratumumab (intravenous, 16 mg/kg) and low dose dexamethasone (oral, 20/10 mg)
• Maintenance therapy: if no progression after induction, patients will be treated with ixazomib (4 mg) and daratumumab (16 mg/kg) until progression for a maximum of 2 years

Inclusion criteria

• Previously untreated patients with a confirmed diagnosis of multiple myeloma according to IMWG criteria
• Measurable diasease
• Patients who are either unfit or frail according to the IMWG criteria
• Age 18 years or older
• Absolute neutrophil count ≥ 1,0 x 10^9/L and platelet count ≥ 75 x 10^9/L 

Exclusion criteria

• Non-secretory multiple myeloma
• Plasma cell leukemia
• Systemic Amyloid Light-chain amyloidosis
• Central nervous system involvement
• Neuropathy, grade 1 with pain or grade  ≥  2
• Severe cardiac dysfunction
• ECG showing a baseline QTcF interval > 470 msec

Participating sites

• ZiekenhuisNetwerk Antwerpen (ZNA)
• AZ St. Jan Brugge - Oostende
• UZ Brussel
• Cliniques Universitaires UCL Saint Luc
• Centre Hospitalier de Jolimont
• Jan Yperman Ziekenhuis Ieper