A Trial for Relapsed and Relapsed/Refractory Multiple Myeloma Patients
Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
Multiple myeloma (MM) with chromosome 17 deletion (del(17p) represents one of the most
dangerous genetic variant of this disease, since it is associated with a high level of
genomic instability. Del(17p) is present in approximately 10% of patients at diagnosis, and
its frequency increases with disease evolution. The adverse prognosis of del(17p) has been
observed in patients treated with conventional chemotherapy and new drugs. Only very few
studies have suggested an advantage in treating del(17p) MM patients with specific therapies.
In particular, several recent trials combining lenalidomide plus dexamethasone with a new
agent, suggested that high risk cytogenetics patients may benefit from newest generation
drugs. Yet, in all studies, outcome of patients with high risk genetic features have been
derived from subgroup analyses, with all the limitations of this approach. To date no trial
has been designed with the specific aim to test genotype-adapted therapies.
The objective of the present study is to evaluate the combination of
daratumumab-pomalidomide-dexamethasone (DPd) in relapsed or relapsed/refractory MM patients
harboring del(17p).
Treatment of relapsed or relapsed/refractory MM patients harbouring del(17p) is a relevant
unmet medical need. A clinical trial designed to test a tailored treatment for this patient
population would be a major improvement. In this perspective the combination DPd seems
attractive since:
- both daratumumab and pomalidomide are therapies not interfering with DNA replication,
thus not increasing the intrinsic genomic instability of del(17p) plasma cells.
- the POLLUX study has shown that daratumumab in combination with lenalidomide is highly
effective in relapsed and relapsed/refractory MM patients.10
- the IFM 2010-02 trial has suggested that pomalidomide may be effective in del(17p)
patients.
- the DPd combination has been successfully tested in MM patients with advanced disease.