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Table 1 Inclusion and exclusion criteria for the GMMG-HD6 trial

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

Inclusion criteria
Patients meeting all of the following criteria will be considered for admission to the trial:
 Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy (diagnostic criteria (IMWG updated criteria (2014). For some patients systemic therapy may be required though these diagnostic criteria are not fulfilled. In this case the GMMG study office has to be consulted prior to inclusion.
 Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements
  Serum M-protein 10 g/l (for IgA  5 g/l)
  Urine light-chain (M-protein) of 200 mg/24 h
  Serum FLC assay: involved FLC level  10 mg/dl provided sFLC ratio is abnormal
  Age 18–70 years inclusive
  WHO performance status 0–3 (WHO = 3 is allowed only if caused by MM and not by co-morbid conditions)
  Negative pregnancy test at inclusion (women of childbearing potential)
  For all men and women of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy. Patients must agree on the requirements regarding the lenalidomide pregnancy prevention programme.
 All patients must
  agree to abstain from donating blood while taking lenalidomide and for 28 days
  following discontinuation of lenalidomide therapy
  agree not to share study drug lenalidomide with another person and to return all
  unused study drug to the investigator or pharmacist
  Ability of patient to understand character and individual consequences of the clinical trial
  Written informed consent (must be available before enrollment in the trial)
Exclusion criteria
Patients presenting with any of the following criteria will not be included in the trial:
 Patient has known hypersensitivity to any drugs given in the protocol, notably bortezomib, lenalidomide, dexamethasone and elotuzumab or to any of the constituent compounds (incl. Boron and mannitol).
 Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow)
 Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 4 weeks prior to study entry.)
 Severe cardiac dysfunction (NYHA classification III-IV, see appendix IIIB)
 Significant hepatic dysfunction (serum bilirubin 1,8 mg/dl and/or ASAT and/or ALAT
   2.5 times normal level), unless related to myeloma. (Note: if the mentioned limits for bilirubin or ASAT/ALAT are exceeded, but there is no significant hepatic dysfunction at investigator’s discretion, the GMMG study office has to be consulted prior to inclusion)
 Patients with renal insufficiency requiring hemodialysis
 HIV positivity
 Patients with active or history of hepatitis B or C
 Patients with active, uncontrolled infections
 Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0, see appendix V)
 Patients with a history of active malignancy during the past 5 years with the exception of basal cell carcinoma of the skin or stage 0 cervical carcinoma treated with curative intent
 Patients with acute diffuse infiltrative pulmonary and/or pericardial disease
 Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
 Platelet count < 75 × 109/l, or, dependent on bone marrow infiltration by plasma cells, platelet count < 30 × 109/l (patients with platelet count < 75 × 109/l, but > 30 × 109/l may be eligible if percentage of plasma cells in bone marrow is 50%), (transfusion support within 14 days before the test is not allowed)
 Haemoglobin < 8.0 g/dl, unless related to myeloma
 Absolute neutrophil count (ANC) < 1.0 × 109/l (the use of colony stimulating factors within 14 days before the test is not allowed), unless related to myeloma
 Pregnancy and lactation
 Participation in other clinical trials. This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months.
 No patient will be allowed to enrol in this trial more than once.