Status:
COMPLETED
Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborating Sponsors:
European Myeloma Network B.V.
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Study phase: phase III Study objective: * Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed autologous stem cell transplantation (ASCT) * Comparison of Bortezom...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Allogeneic Stem Cell Transplantation (Allo SCT) planned;
- Progressive disease.'
- Exclusion for randomisation 2:
- Progressive disease;
- Neuropathy, except CTCAE grade 1;
- CTCAE grade 3-4 polyneuropathy during Bortezomib treatment.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
1503 Patients enrolled
Trial Details
Trial ID
NCT01208766
Start Date
January 1 2011
End Date
January 1 2025
Last Update
January 6 2026
Active Locations (208)
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1
AU-Brisbane-PAH
Brisbane, Australia
2
AU-Canberra-CANBERRAHOSPITAL
Canberra, Australia
3
AU-Melbourne-ALFRED
Melbourne, Australia
4
AU-Sydney-CONCORD
Sydney, Australia