Clareo Health | Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stichting Hemato-Oncologie voor Volwassenen Nederland
With
European Myeloma Network B.V.
Gruppo Italiano Malattie EMatologiche dell'Adulto
DSMM (Deutsche Studiengruppe Multiples Myelom)
NMSG (Nordic Myeloma Study Group)
Central European Myeloma Study Group
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with a confirmed diagnosis of symptomatic multiple myeloma stage I to III according to the International Staging System ISS (see appendix A), i.e. at least one of the CRAB criteria should be present;
Measurable disease as defined by the presence of M-protein in serum or urine (serum M-protein\> 10 g/l or urine M-protein \> 200 mg/24 hours), or abnormal free light chain ratio;
Age 18-65 years inclusive;
WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by comorbid conditions);
Negative pregnancy test at inclusion if applicable;
Written informed consent.
Inclusion for randomisation 1:
WHO performance 0-2;
Bilirubin and transaminases \< 2.5 times the upper limit of normal values;
A suitable stem cell graft containing at least 4 x 106 CD34+ cells/kg (or according to national guidelines).
Inclusion for randomisation 2:
Bilirubin and transaminases \< 2.5 times the upper limit of normal values;
ANC \>= 0.5 x 109/l and platelets \> 20 x 10\^9/l;
Patient is able to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan.
You may not be if
Known intolerance of Boron;
Systemic AL amyloidosis;
Primary Plasmacell Leukemia;
Non-secretory MM;
Previous chemotherapy or radiotherapy except local radiotherapy in case of local myeloma progression or corticosteroids maximum 5 days for symptom control;
Severe cardiac dysfunction (NYHA classification II-IV);
Significant hepatic dysfunction, unless related to myeloma;
Patients with GFR \<15 ml/min,
Patients known to be HIV-positive;
Patients with active, uncontrolled infections;
Patients with neuropathy, CTC grade 2 or higher;
Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women);
Lactating women.
Exclusion for randomisation 1:
Severe pulmonary, neurologic, or psychiatric disease;
CTCAE grade 3-4 polyneuropathy during Bortezomib treatment;
