Greek Team Helps Advance New Multiple Myeloma Treatment

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A new treatment option for multiple myeloma has received accelerated approval from the US Food and Drug Administration (FDA), following clinical research that included active participation from a Greek medical centre.

The FDA approved iberdomide, a new oral agent from the CELMoD (Cereblon E3 Ligase Modulator) class, in combination with daratumumab and dexamethasone for adults with multiple myeloma who have received at least one previous line of treatment that included a proteasome inhibitor and an immunomodulatory agent.

The Therapeutic Clinic of the National and Kapodistrian University of Athens (NKUA) Medical School took part in the international EXCALIBER-RRMM clinical trial, whose results formed the basis for the approval.

Professor of Therapeutics-Oncology Maria Gavriatopoulou served as the principal investigator at the Greek centre, while Professor of Therapeutics-Oncology-Haematology and director of the Therapeutic Clinic Thanos Dimopoulos serves on the study’s international Steering Committee.

Trial shows deeper treatment response

EXCALIBER-RRMM was an international, randomised, multicentre Phase III trial that evaluated oral iberdomide combined with subcutaneous daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma who had received one or two previous lines of treatment.

In the primary efficacy analysis, 41% of patients receiving the iberdomide, daratumumab and dexamethasone combination achieved a complete response with negative minimal residual disease (MRD), compared with 21% of patients receiving the standard combination of daratumumab, bortezomib and dexamethasone.

Negative minimal residual disease represents a particularly important measure of the depth of treatment response in multiple myeloma and is associated with improved survival measures.

Researchers said further confirmation of the treatment’s clinical benefit will come from ongoing trial data, including results on progression-free survival and overall survival.

New class of treatment

Iberdomide belongs to a new generation of CELMoD agents. These drugs act through the cereblon-E3 ubiquitin ligase complex, leading to the breakdown of specific proteins that play an important role in the survival of myeloma cells while also producing an immunomodulatory effect.

Scientists involved in the research said the approval marks the arrival of this new therapeutic class in multiple myeloma treatment and expands the options available to patients whose disease has returned.

They also highlighted the contribution of the NKUA Therapeutic Clinic to the international study, saying its involvement demonstrates the clinic’s longstanding role in international clinical research.

The participation also gives patients in Greece earlier access to innovative treatments through clinical trials, the researchers said.

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