Last reviewed · How we verify
Treatment of Patients with Relapsed/Refractory Multiple Myeloma with Ruxolitinib, Methylprednisolone and Lenalidomide: Using Changes in Serum B-Cell Maturation Antigen (BCMA) or International Multiple Working Group (IMWG) Criteria to Determine Disease Progression in Order to Add Lenalidomide to Those Failing the Ruxolitinib/Methylprednisolone Combination
This is a phase 1, multicenter, open-label study evaluating the safety and efficacy of ruxolitinib, steroids and lenalidomide among MM patients who currently show progressive disease using BCMA to test progression.
Details
| Lead sponsor | Oncotherapeutics |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | RECRUITING |
| Enrolment | 30 |
| Start date | 2022-12-08 |
| Completion | 2029-02 |
Conditions
- Multiple Myeloma
Interventions
- Ruxolitinib Oral Tablet [Jakafi]
- Lenalidomide
- Methylprednisolone
Primary outcomes
- Time to Disease Progression (TTP) — 54 months
* To establish the utility of using an increase in sBCMA levels \> 25% or IMWG criteria for disease progression to direct this therapeutic approach, TTP will be measured, where TTP is defined as a number of days between the start of treatment (cycle 1 day 1) and PD. PD is defined by either change in sBCMA (≥25% increase from its nadir levels) or by standard IMWG criteria (using sM-protein and SFLC assessments), whichever occurs first. PD will be confirmed by two consecutive tests. * Duration of response 1 (DOR1), defined as the time from the first response to progressive disease as determined by either changes in sBCMA or IMWG criteria (whichever occurs first) while patients are on ruxolitinib and methylprednisolone treatment * Duration of response 2 (DOR2), defined as the time from the first response to progressive disease as determined by standard IMWG criteria while patients on ruxolitinib, lenalidomide and methylprednisolone treatment
Countries
United States