Multiple Myeloma MedDRA version: 18.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: REVLIMID® 5mg cápsulas duras
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Fundación PETHEMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must voluntarily sign and understand written informed consent. 2. Subject is ? 65 years at the time of signing the consent form. 3. Subject has histologically confirmed MM that has never before been treated, and according to the following definition of MM: Clonal bone marrow plasma cells ? 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events: 1. Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: - Hypercalcaemia: serum calcium > 0,25 mmol/L (> 1mg/dL) higher than the upper limit of normal or > 2,75 mmol/L (>11 mg/dL) - Renal insufficiency: creatinine clearance 177 µmol/L (>2 mg/dL) - Anaemia: haemoglobin value of > 20 g/L below the lower limit of normal, or a haemoglobin value 1 focal lesions on MRI studies 4. Subject has no prior anti-myeloma treatment therapy within 14 days prior to initiation of study treatment except for corticosteroids with a maximum allowed dosage equivalent to three pulses of dexamethasone (40mg daily for 4 days equals one pulse). 5. Patients may have received prior adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care, or radiation therapy as palliation for pain and/or spinal cord compression 6. Subject has measurable disease as defined by > 0.5 g/dL serum monoclonal protein, > 10 mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, >0 .2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either CT scanning or MRI. 7. Subject has a Karnofsky performance status ? 60% (> 50% if due to bony involvement of myeloma). 8. Subject is able to take prophylactic anticoagulation (patients intolerant to aspirin may use warfarin, acenocumarol or low molecular weight heparin). 9. If subject is a female of childbearing potential (FCBP), she must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 ? 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with FCBP even if they have had a successful vasectomy. 10. Subject has a life expectancy ? 3 months 11. Subjects must meet the following laboratory parameters: - Absolute neutrophil count (ANC) ? 1.0 x 10^9/L. - Hemoglobin ? 7 g/dL. - Platelet count ? 75.000/mm3 ( > 30 x 10^9/L if extensive bone marrow infiltration). - Serum SGOT/AST < 3.0 x upper limits of normal (ULN). - Serum SGPT/ALT < 3.0 x upper limits of normal (ULN). - Serum total bilirubin < 2.0 mg/dL (3
Exclusion criteria
Exclusion criteria: 1. Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning) 2. Subject has a prior history of other malignancies unless disease-free for ? 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score < 7 with stable prostate specific antigen (PSA) levels 3. Subject has had myocardial infarction within 6 months prior to enrollment, or NYHA (New York Hospital Association) Class III or IV heart failure (see Appendix VI), Ejection Fraction < 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, evidence of prolonged QTc interval in pre-treatment electrocardiogram, or active conduction system abnormalities 4. Female subject who is pregnant or lactating 5. Subject has known HIV infection 6. Subject has known active hepatitis B or hepatitis C infection 7. Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program 8. Subject is unable to reliably take oral medications 9. Subject has known hypersensitivity to dexamethasone, clarithromycin, lenalidomide, or thalidomide 10. Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment 11. Subject has any clinically significant medical or psychiatric disease or condition that, in the investigator?s opinion, may interfere with protocol adherence or a subject?s ability to give informed consent 12. Subject has previously been treated for MM
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare efficacy of the BiRd regimen vs Rd;Secondary Objective: - To evaluate the efficacy of clarithromycin, lenalidomide (Revlimid®), and dexamethasone combination therapy (BiRd), compared to lenalidomide and dexamethasone (Rd) alone as an induction therapy for patients with newly diagnosed, transplant ineligible, previously untreated MM. - To compare ORR of BiRd versus Rd. - To determine and compare the following: DOR, EFS, TTP, and OS of BiRd versus Rd. - To assess safety and drug toxicity in each arm. - To determine relative dose intensity for each component of protocol medication prescribed. - To evaluate and compare minimal residual disease following therapy of BiRd versus Rd. - To determine and compare the efficacy of BiRd versus Rd from study entry until 2nd instance of disease progression. - To assess determine and compare quality of life assessments for BiRd vs Rd.;Primary end point(s): Progression-Free Survival (PFS).;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Response rate by IMWG criteria. 2. Event free survival (EFS) (an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, or death). 3. Overall survival (OS). 4. Duration of response (DOR). 5. Time-To Progression (TTP). 6. PFS 2: time from study entry until 2nd instance of disease progression. 7. Quality of life: as measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT Fatigue) Scale as part of a quality of life assessment. 8. Regimen toxicities, as defined by CTCAE V4.0.;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Countries
Spain, United States
Contacts
Public ContactInvestigación Clínica
CABYC, S.L.
Outcome results
None listed