Pom-dex Versus Pom-Cyclo-dex in MM Patients With Biochemical or Clinical Relapse, During Lena Maintenance Treatment
Status:
Terminated
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
Summary
The combination lenalidomide plus low-dose dexamethasone (Rd) is an active treatment for
Multiple Myeloma (MM) patients, both at diagnosis and at relapse.
Pomalidomide, is an immunomodulatory molecule (IMID), derivative of thalidomide, developed to
improve the efficacy and reduce the toxicity of the parent molecule. Pomalidomide and
dexamethasone (pom-dex) proved to be an effective and safe treatment in MM patients
refractory to lenalidomide and refractory/intolerant to bortezomib.
The addition of chemotherapy to novel drugs has been evaluated both at diagnosis and at
relapse. The combination of pomalidomide-cyclophosphamide-prednisone proved to be safe and
effective in relapsed/refractory MM patients. The combination
pomalidomide-cyclophosphamide-dexamethasone (pom-cyclo-dex) was tested in a phase II study in
patients with relapsed and refractory MM, demonstrating a good tolerability using
pomalidomide at the dose of 4 mg. Pom-cyclo-dex resulted in a superior response rate and
Progression-Free Survival (PFS) compared to pom-dex. The increased hematologic toxicities, as
a result of the addition of oral cyclophosphamide, were manageable. With an overall response
rate of 65% the combination demonstrated a promising efficacy.The first aim of our trial, is
to compare the combination of pom-cyclo-dex vs pom-dex.
Relapsed myeloma is defined as previously treated myeloma that progresses and requires the
initiation of salvage therapy.
According to International Myeloma Working Group (IMWG) recommendation, biochemical relapse
is defined as an increase of ≥ 25% of tumor burden from lowest value, without any CRAB
feature (CRAB is defined as the onset of clinical symptoms: hypercalcemia, renal failure,
anemia and bone lesions) and detected in 2 consecutive determinations.
Clinical relapse requires one or more direct indicators of progressive disease and end organ
dysfunction (CRAB features).
Treatment at relapse should start in case of clinical relapse or a significant paraprotein
increase (doubling of M-component in 2 months).
In case of biochemical relapse the standard is observation only, as in case of asymptomatic
MM at diagnosis.
However, a recently published trial, showed improved PFS and OS for newly diagnosed
asymptomatic patients treated with lenalidomide and dexamethasone in comparison with
observation only. Our hypothesis is that similarly, in the relapse setting, patients may
benefit from an early intervention, meaning a treatment at biochemical relapse and not only
in case of clinical relapse or rapid increase of M-component.