Table 1.
Inclusion and exclusion criteria
| Inclusion criteria |
| • Understanding of the nature and consequences of the trial and voluntary signature of the informed consent document |
| • Age ≥ 18 and ≤ 75 years at the time of consent and randomization |
| • Availability of stem cells from earlier harvesting if age ≥ 71 years |
| • 1st to 3rd relapse of symptomatic MM (according to IMWG criteria [51]) |
| • Salmon and Durie stage [58] II or III |
| • Duration of response ≥ 12 months in case of first-line HDCT/ASCT |
| • WHO performance status (WHO PS) ≤ 2 |
| • Laboratory findings within the following ranges ○ Absolute neutrophil count ≥ 1/nl ○ Platelet count ≥ 75/nl (depending on bone marrow infiltration with myeloma cells, platelet count ≥ 30/nl may be acceptable) ○ Creatinine clearance ≥ 30 ml/min ○ Total bilirubin ≤ 2 x the upper limit of normal (ULN; except for elevations caused by MM) ○ Alanine aminotransferase (ALT) ≤ 3 x ULN (except for elevations caused by MM) |
| • Absence of malignant diseases other than MM for ≥ 5 years (except basal-cell carcinoma and carcinoma in situ of the skin, the cervix and the breast) |
| • Ability to apply thrombosis prophylaxis |
| • Consent to all protocol requirements, especially those regarding the trial visit schedule and the pregnancy prevention program |
| Exclusion criteria |
| • Pregnant or breastfeeding female |
| • Previous treatment with lenalidomide, if: ○ Refractory (i.e. stable disease (SD) or progressive disease (PD) on treatment or ≤ 60 days after the end of treatment) ○ PD ≤ 6 months after the end of treatment if patient had responded (i.e. ≥ MR) |
| • Previous salvage HDCT/ASCT |
| • Known hypersensitivity to thalidomide, lenalidomide or components of lenalidomide |
| • Erythema nodosum as an exfoliative rash while on thalidomide |
| • Exposure to any other experimental substance within 28 days prior to enrollment |
| • Non-secretory MM (with normal free light chain ratio) that cannot be monitored by radiographic (e.g. MRI) examination |
| • Systemic amyloidosis with organ involvement (with the exception of AL-amyloidosis of the skin and/or bone marrow) |
| • Plasma cell leukemia |
| • Previous allogeneic stem cell transplantation |
| • Active, uncontrolled infectious disease |
| • Known positivity for HIV, hepatitis B or C |
| • Congestive heart failure (NYHA ≥ 3) |
| • Severe pulmonary, neurologic or psychiatric disease |