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 |