A Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma

• Status: Completed
• Trial end date: 2021-06-24
• Target enrollment: 0
• Participant gender: All

Summary

Trial in patients with newly diagnosed myeloma to evaluate the effect of elotuzumab in induction and consolidation therapy with bortezomib/lenalidomide/dexamethasone and in lenalidomide maintenance treatment

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Heidelberg Medical Center
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Elotuzumab; Lenalidomide; Thalidomide

Criteria

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) )

• Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements:

• Serum M-protein ≥ 10g/l (for IgA ≥ 5g/l)

• Urine light-chain (M-protein) of ≥ 200 mg/24 hours

• 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 described in chapter 6.

• 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.

• Severe cardiac dysfunction (NYHA classification III-IV)

• Significant hepatic dysfunction (serum bilirubin ≥ 1,8mg/dl and/or ASAT and/or ALAT ≥ 2.5 times normal level), unless related to myeloma.

• 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)

• 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 x 109/l, or, dependent on bone marrow infiltration by plasma cells, platelet count < 30 x 109/l (patients with platelet count < 75 x 109/l, but > 30 x 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 x 10^9/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 patients will be allowed to enrol in this trial more than once.