Short summary

Design: Phase II, prospective, open label, randomized controlled clinical trial Participating sites: 6 sites in the Nordic Myeloma Study Group (Denmark, Norway, Estonia)

Rationale

The evidence supporting immunoglobulin replacement therapy in patients with secondary immunodeficiencies is limited, the recommendations are based on expert opinions, and practices differ widely. Immunoglobulin replacement therapy in multiple myeloma has only been assessed in a few trials, but with positive results. The use of immunoglobulin replacement therapy as primary prophylaxis in newly diagnosed patients with multiple myeloma is unexplored. The study hypothesis is that primary immunoglobulin prophylaxis with HyQvia will reduce the number of infections and early mortality compared to standard of care. Patients in the intervention arm will receive HyQvia for 12 cycles. The length of each cycle will be 28 days. HyQvia will be administered twice (on days 1 and 8) in the first cycle, and once (on day 1) in every subsequent cycle. HyQvia 10% human normal immunoglobulin will be dosed according to the following table: Cycle 1 Cycles 2-12 Day 1: 5 g Day 1: 20 g Day 8: 10 g The target interval for serum non-monoclonal IgG trough levels is 6-12 g/l. For the first three HyQvia infusions the dose is fixed. After the third infusion, the dose of HyQvia may be adjusted based on serum non-monoclonal IgG trough levels. Patients in the observation arm will receive standard of care infection prophylaxis as per local institutional standards.

Description of the cohort

100 adults with newly diagnosed symptomatic/active multiple myeloma ineligible for treatment with high-dose melphalan and autologous stem cell transplantation

Data and biological material

Blood samples and quality of life questionnaires will be collected at screening and on day 1 of cycles 1, 4, 7, 10, and at the end of treatment/observation visit.

Collaborating researchers and departments

Department of Hematology Odense University Hospital

• Mette Christoffersen

Department of Hematology Copenhagen University Hospital

• Agoston Gyula Szabo

Department of Hematology Gødstrup Hospital

• Tobias Eberlein

Tallinn Hospital

• Diana Loigom

Oslo Myeloma Center

• Fredrik Schjesvold