This protocol is a phase II multi­center, ran­dom­ized, open label study designed to assess the efficacy and safety of dara­tu­mu­mab com­bined with bor­tez­o­mib, cyclophosphamide and dexa­meth­a­sone (Dara-VCd) versus the association of bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) as pre trans­plant induction and post trans­plant consolidation, followed by main­te­nance with ixazomib alone or in com­bi­na­tion with dara­tu­mu­mab, in newly diag­nosed multiple myeloma (MM) patients eli­gible for au­tol­o­gous stem cell trans­plan­ta­tion.

Patients enrolled in the Dara-VCd arm will receive: 4 cycles of dara­tu­mu­mab-bortezomib-cyclophosphamide-dexamethasone induction, followed by trans­plan­ta­tion and 2 cycles of dara­tu­mu­mab-bortezomib-cyclophosphamide-dexamethasone consolidation. The choice of cyclophosphamide in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone is suggested by the better safety profile of cyclophosphamide, in …

Multiple myeloma (MM) survival has been im­proved during the last decade owing to new treat­ments. Hence, it has become a matter of importance to precisely define the depth of MM response to ther­apy. 18F-FDG PET/CT (FDG-PET) has proved to be superior to X-rays for the initial staging of MM. It is now recommended by the Inter­na­tional Myeloma Work­ing Group (IMWG) during the initial work-up and for response evaluation, as it is superior to MRI in that setting. However, sensitivity of FDG-PET remains inferior to that of MRI for the initial staging of MM. Indeed, FDG-PET remains limited for the evaluation of skull lesions (due to brain physiological back­ground) or spine …

The objective of this project is to compare chemo­sensi­tiv­ity be­tween chemo­ther­apy com­bi­na­tions in bone marrow aspirates using 3D organoid models. The investigators overarching hypothesis is that 3D organoids are ideal to test chemo­sensi­tiv­ity in real time, to provide personalized medicine and guidance in the setting of re­lapsed multiple myeloma and poten­tially other cancers.

Enrollment status: Not yet recruiting.
Estimated start date: April 2019.

Countries with trial sites (# of sites): Unknown at this time.

Type of trial: Observational.
Phase of trial: Not specified.

Trial IDs: NCT03890614, WFBCCC 26A19.

Detailed Description

Optimize the novel 3D organoid technique already used to recreate myeloma tumors in the Regenerative Medicine laboratory.

Optimize cell viability of myeloma organoids to extend …

This is a non-randomized, open label, Phase 1/2, dose-escalation study, involving a single injection of Temferon, an inves­ti­ga­tional ad­vanced ther­apy consist­ing of au­tol­o­gous CD34+-enriched hemato­poietic stem and progenitor cells exposed to trans­duction with a lentiviral vector driving myeloid-specific interferon-ɑ2 ex­pres­sion, which will be admin­istered to up to 9 patients affected by multiple myeloma in early relapse after intensive front line treat­ment.

Enrollment status: Recruiting.

Countries with trial sites (# of sites): Italy (1).

Type of trial: Interventional.
Phase of trial: Phase 1/2.

Trial IDs: NCT03875495 and TEM-MM-101.

Detailed description

This is a non-randomized, open label, single center, phase I/II, thera­peutic exploratory, dose-escalation, pro­spec­tive­ study, involving a single in­tra­venous …