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 1

• Conditions: ewly diagnosed symptomatic multiple myeloma; MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-003079-40-DE
• Lead Sponsor: Ruprecht-Karls-University Heidelberg, Medical Faculty represented by University Hospital Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-16
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 564

Inclusion Criteria

- Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy (updated IMWG criteria for diagnosis of MM, 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 comorbid 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 424
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

- Patient has known hypersensitivity to any drugs given in the protocol, notably bortezomib, lenalidomide, dexamethasone and elotuzumab or to any of the constituent compounds.
- 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
- Significant hepatic dysfunction
- 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
- Platelet count < 75 x 10^9/l, or, dependent on bone marrow infiltration by plasma cells, platelet count < 30 x 10^9/l
- Haemoglobin < 8.0 g/dl, unless related to myeloma
- Absolute neutrophil count (ANC) < 1.0 x 10^9/l

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified