A randomized phase III trial assessing the benefit of the addition of isatuximab to lenalidomide / bortezomib / dexamethasone (RVd) induction and lenalidomide maintenance in patients with newly diagnosed multiple myeloma - GMMG-HD7

Ruprecht-Karls-University Heidelberg, Medical Faculity, represented by University Hospital Heidelberg0 sites662 target enrollmentMay 28, 2018

Conditionsewly diagnosed symptomatic multiple myeloma MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

DrugsRevlimid® 5 mg Revlimid® 10 mg Revlimid® 15 mg Revlimid® 25mg

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ewly diagnosed symptomatic multiple myeloma
Sponsor: Ruprecht-Karls-University Heidelberg, Medical Faculity, represented by University Hospital Heidelberg
Enrollment: 662
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 28, 2018

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Ruprecht-Karls-University Heidelberg, Medical Faculity, represented by University Hospital Heidelberg

Eligibility Criteria

Inclusion Criteria

•\- 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.
•\- Patient is eligible for high dose therapy and autologous stem cell transplantation.
•\- 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 and abnormal sFLC ratio
•\- Age 18 \- 70 years inclusive
•\- WHO performance status 0\-2
•\- 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

Exclusion Criteria

•\- Patient has known hypersensitivity (or contraindication) to dexamethasone, sucrose histidine (as base and hydrochloride salt), boron, mannitol, and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids or H2 blockers that would prohibit further treatment with these agents.
•\- Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow)
•\- Plasma cell leukemia
•\- Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma Progression or benign diseases, such as non\-malignant thyroid diseases. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy.) Previous therapy due to smouldering myeloma may be acceptable. In this case the GMMG study office has to be consulted prior to inclusion.
•\- Severe cardiac dysfunction (NYHA classification III\-IV)
•\- Significant hepatic dysfunction (ASAT and/or ALAT \= 3 times normal level and/or serum bilirubin \= 1\.5 times normal level if not due to hereditary abnormalities as Gilbert’s disease), unless related to myeloma.
•\- Patients with active or history of hepatitis B or C (Prior hepatitis B may be acceptable if an adequate prophylaxis is being implemented during the course of the study.)
•\- HIV positivity
•\- Patients with active, uncontrolled infections
•\- Patients with severe renal insufficiency (Creatinine Clearance \< 30ml/min)