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Table 1 Inclusion and exclusion criteria

From: Rationale and design of the German-Speaking Myeloma Multicenter Group (GMMG) trial ReLApsE: a randomized, open, multicenter phase III trial of lenalidomide/dexamethasone versus lenalidomide/dexamethasone plus subsequent autologous stem cell transplantation and lenalidomide maintenance in patients with relapsed multiple myeloma

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