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Table 2 Recommended timepoints of response evaluation

From: Rationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma

Treatment period Timepoint of response evaluation
After induction treatment d21 – d35 after start of 4th cycle VRD
After first chemotherapy cycle of intensification regime (mobilization) d23 – d33 after start of this cycle (previous to high dose therapy)
After subsequent chemotherapy cycles of inten sification regime According to local policy: d60 - d90 after start of high dose therapy cycle recommended (previous to next cycle)
After VRD consolidation d21–35 after start of 2nd cycle VRD
During maintenance every 3 months
Follow up, i.e. after individual “end of study”, (until 1st PD) Evaluation is recommended every 3 months. As long as there is no change in response status, es- pecially no progressive disease, CRF documentation of the FU visit is sufficient every 6 months. The timepoint of diagnosis of progressive disease has to be documented in the eCRF, even if it doesn’t correspond to a regular 3- or 6-month visit, respectively.
Follow up, after 1st PD There are no specific recommendations for the evaluation schedule after 1st PD as 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 documentation in FU after 1st PD are as follows: update of the survival status at least every 6 months (incl. Information on secondary primary malignancies and on the timepoint of diagnosis of subsequent “PD”). Each line of therapy should be recorded separately