from the Intergroupe Francophone du Mylome (IFM) (Cassiopeia, “type”:”clinical-trial”,”attrs”:”text”:”NCT02541383″,”term_id”:”NCT02541383″NCT02541383). Given the previously explained study results in the relapsed establishing, an improvement of the therapeutic effects by the addition of the humanized monoclonal antibody elotuzumab can be expected. by 2?cycles of VRD consolidation and lenalidomide maintenance. Individuals in arm B1?+?B2 will additionally receive elotuzumab in the induction phase, whereas individuals in A2?+?B2 will be treated with elotuzumab added to p-Cresol consolidation and maintenance. The primary endpoint of the trial is definitely PFS. Secondary objectives and endpoints are OS, CR rates after induction therapy comparing the two arms VRD (A1?+?A2) vs VRD?+?elotuzumab (B1?+?B2), CR rates after consolidation treatment, best response to treatment during the study, time to progression (TTP), duration of response (DOR), toxicity and quality of life. Results Since this is the publication of a study protocol of an ongoing study, no results can be offered. Discussion This phase III trial is designed to evaluate whether the addition of elotuzumab to an intensified treatment concept with high dose melphalan chemotherapy plus autologous stem cell transplantation and induction, consolidation and maintenance treatment with bortezomib and p-Cresol lenalidomide is able to improve PFS compared to the same concept without p-Cresol elotuzumab. Trial sign up “type”:”clinical-trial”,”attrs”:”text”:”NCT02495922″,”term_id”:”NCT02495922″NCT02495922 on June 24th, 2015. relapse in the non-transplant establishing. Results of phase I, II and phase III trials evaluating the combination of elotuzumab and bortezomib or lenalidomide IgM Isotype Control antibody (PE-Cy5) and dexamethasone display very good tolerability and high response rates in individuals with relapsed/refractory myeloma [20, 21]. While the results of use of elotuzumab in monotherapy were modest with stable disease as best p-Cresol response  the combination with lenalidomide and dexamethasone offers given excellent results with cycle VRDAfter 1st chemotherapy cycle of intensification program (mobilization)d23 C d33 after start of this cycle (previous to high dose therapy)After subsequent chemotherapy cycles of inten sification regimeAccording to local policy: d60 – d90 after start of high dose therapy cycle recommended (previous to next cycle)After VRD consolidationd21C35 after start of 2cycle VRDDuring maintenanceevery 3?monthsFollow up, i.e. after individual end of study, (until 1PD)Evaluation is recommended every 3?weeks. As long as there is no switch in response status, sera- pecially no progressive disease, CRF paperwork of the FU check out is sufficient every 6?weeks. The timepoint of analysis of progressive disease has to be recorded in the eCRF, actually if it doesnt correspond to a regular 3- or 6-month check out, respectively.Follow up, after 1st PDThere are no specific recommendations for the evaluation routine after 1st PD mainly because course of the disease and therapies for relapsed and/or refractory myeloma vary and the visits have to be adapted to the requirements of the individual patient. The requirements for eCRF paperwork in FU after 1st PD are as follows: update of the survival status at least every 6?weeks (incl. Info on secondary main malignancies and on the timepoint of analysis of subsequent PD). Each line of therapy should be recorded separately Open in a separate windows Trial treatmentFigure?1 includes a compact overview of the trial treatment. Open in a separate window Fig. 1 GMMG HD6 trial summary After the inclusion in the study, all patients no matter randomization will receive an induction treatment consisting of 4 VRD cycles of 21 days each (bortezomib 1.3 mg/m2 s.c. on days 1,4,8,11, oral lenalidomide 25 mg on days 1-14, oral dexamethasone 20 mg on days 1,2,4,5,8,9,11,12, additionally in cycle 1 and 2 on day time 15). Individuals in arm B1 and B2 will additionally become treated with elotuzumab 10 mg/kg on days 1,8,15 in cycle 1 and 2, days 1 and 11 in cycles 3 and 4. All qualified individuals will be given an intensified therapy program relating to GMMG standard protocols. A popular routine for intensified therapy is definitely: stem cell collection after CAD mobilization followed by high dose melphalan (200 mg/m2) and autologous stem cell save. GMMG standard is definitely a single HDT and ASCT for individuals who reach at least a CR and tandem HDT and ASCT for individuals who do not reach CR. Although the details of stem cell collection, HDT and ASCT are not specified in the study protocol. Three months after the beginning of the last HDT cycle patients should get consolidation treatment consisting of 2 cycles of VRD of 21 days each with weekly administration of bortezomib (bortezomib 1.3 mg/m2 s.c. on days 1,8,15, oral lenalidomide.