Randomized Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone to High-Dose Treatment With ASCT in the Initial Management of Myeloma in Patients up to 65 Years of Age
Inclusion Criteria for registration :
(with labs performed within 21 days of initiation of protocol therapy):
- Patients diagnosed with multiple myeloma based on International Myeloma Foundation
2003 Diagnostic Criteria.
- Patients must have symptomatic myeloma with myeloma-related organ damage.
- Patients must have myeloma that is measurable by either serum or urine evaluation of
the monoclonal component or by assay of serum free light chains.
- Age between 18 and 65 years at the time of signing the informed consent document.
- ECOG performance status <2 (Karnofsky ≥ 60%)
- Negative HIV blood test
Exclusion Criteria for registration (section 4.2):
- Participants must not have been treated with any prior systemic therapy for multiple
myeloma. Treatment by localized radiotherapy is not an exclusion criterion if an
interval of at least two weeks between the end of radiotherapy and initiation of
protocol therapy entry in the study is observed. Similarly, the dose of
corticosteroids received by the participant should not exceed the equivalent of 160
mg of dexamethasone over a two-week period before initiation of protocol therapy.
- Primary amyloidosis (AL) or myeloma complicated by amylosis.
- Participants may not be receiving any other study investigational agents.
- Participants with known brain metastases
- Poor tolerability or known allergy to any of the study drugs or compounds of similar
chemical or biologic composition to study agents
- Platelet count < 50,000/mm3 per µLwithin 21 days of initiation of protocol therapy.
Transfusion within 7 days of screening is not allowed to meet platelet eligibility
- ANC < 1,000 cells/mm3 within 21 days of initiation of protocol therapy. Growth factor
within 7 days of screening is not allowed to meet ANC eligibility criteria.
- Hemoglobin < 8.0 g/dL within 21 days of initiation of protocol therapy. Transfusion
may be used to meet hemoglobin eligibility criteria.
- Hepatic impairment, defined a bilirubin > 1.5 x institutional upper limit of normal
(ULN) > 2 mg/dL (Patients with benign hyperbilirubinemia (e.g., Gilbert's syndrome)
are eligible) and or AST (SGOT), or ALT (SGPT), or alkaline phosphatase > 2 x ULN
- Renal insufficiency, defined as serum creatinine > 2.5 mg/dl and/or creatinine
clearance < <40 60 ml/min (actual or calculated). The Cockgroft-Gault formula should
be used for calculating creatinine clearance values, and may be located in Section
- Respiratory compromise, defined as ventilation tests and with DLCO < 50%
- Participant must not demonstrate with clinical signs of heart or coronary failure, or
evidence of LVEF < 40%. Participant must not have with myocardial infarction within 6
months prior to enrollment or have New York Heart Association (NYHA Appendix VII)
Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular
arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction
system abnormalities. Prior to study entry, any ECG abnormality at screening has to
be documented by the investigator as not medically relevant.
- Intercurrent illness including, but not limited to ongoing or active severe
infection, known (active or not) infection with hepatitis B or C virus, poorly
controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric
illness/social situations that would limit compliance with study requirements.
- Participant with previous history of another malignant condition, except for basal
cell carcinoma and stage I cervical cancer
- Female participant who is pregnant or breast-feeding
- Inability to comply with an anti-thrombotic treatment regimen
- Peripheral neuropathy ≥ Grade 2 peripheral neuropathy on clinical examination within
21 days of initiation of protocol therapy
- Mental illness likely to interfere with participation in the study and Adults under