Multiple myeloma is an incurable and life-threatening blood cancer that
is characterised by tumour proliferation and suppression of the immune
system.1 It is a rare but deadly disease—around 39,000 people
are diagnosed with MM in
For newly diagnosed, transplant-eligible MM patients, key treatment goals are to obtain and to maintain a deep response to therapy, with the ultimate objective of delaying disease progression.5,6 These patients typically receive induction therapy and high-dose chemotherapy with melphalan followed by ASCT. This treatment approach has been an established standard of care for over 20 years.7 Considering that over half of patients relapse within 2 to 3 years after ASCT,8,9 trials have been conducted to assess whether maintenance therapy following ASCT could enable more durable remissions.
"Studies show that maintenance treatment after ASCT with REVLIMID®
may help control residual malignant cells and delay tumour growth by
enhancing immune function," says Professor
The CHMP recommendation was based on the results of two cooperative group-led studies, CALGB 10010410 and IFM 2005-0211:
In the two phase III studies, REVLIMID® monotherapy as maintenance treatment post-ASCT significantly reduced the risk of disease progression or death in patients with MM, leading to the studies being unblinded based on passing their pre-specified boundary for superiority at interim analysis.
In these studies, the safety profile was in line with other clinical data in newly diagnosed non-stem cell transplant (NSCT) and post-approval safety study in relapsed/refractory MM (rrMM). Across both phase III clinical studies, the most commonly reported adverse events (AE) were haematological and included neutropenia and thrombocytopenia. The most commonly reported non-haematological AE were infections. In both trials, an increased incidence rate of haematologic second primary malignancies (SPMs) has been observed in the REVLIMID® group compared with the placebo group. However, the CHMP positive opinion confirms that the benefit-risk ratio for REVLIMID® is positive in this expanded indication.
The CHMP reviews applications for all 28 member states in the
About CALGB 100104
CALGB 100104 was a phase III, randomised, controlled, double-blind,
multi-centre study conducted in 47 centres in
About IFM 2005-02
IFM 2005-02 was a phase III, controlled, double-blind, multi-centre
study conducted in 77 centres across 3 countries in
REVLIMID® in combination with dexamethasone is approved in
REVLIMID® is also approved in
In addition, REVLIMID® is approved in
ADDITIONAL IMPORTANT SAFETY INFORMATION based on EU SmPC
REVLIMID® (lenalidomide) is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients in the formulation.
REVLIMID® (lenalidomide) is contraindicated during pregnancy, and also in women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
Warnings and precautions
Pregnancy: the conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential.
Cardiovascular disorders: patients with known risk factors for myocardial infarction or thromboembolism should be closely monitored.
Neutropenia and thrombocytopenia: complete blood cell counts should be performed every week for the first 8 weeks of treatment and monthly thereafter to monitor for cytopenias. A dose reduction may be required.
Infection with or without neutropenia: all patients should be advised to seek medical attention promptly at the first sign of infection.
Renal impairment: monitoring of renal function is advised in patients with renal impairment.
Thyroid disorders: optimal control of co-morbid conditions influencing thyroid function is recommended before start of treatment. Baseline and ongoing monitoring of thyroid function is recommended.
Tumour lysis syndrome: patients with high tumour burden prior to treatment should be monitored closely and appropriate precautions taken.
Allergic reactions: patients who had previous allergic reactions while treated with thalidomide should be monitored closely.
Severe skin reactions: REVLIMID® (lenalidomide) must be discontinued for exfoliative or bullous rash, or if SJS or TEN is suspected, and should not be resumed following discontinuation for these reactions. Interruption or discontinuation of lenalidomide should be considered for other forms of skin reaction depending on severity. Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide.
Lactose intolerance: patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Second primary malignancies (SPM): the risk of occurrence of hematologic SPM must be taken into account before initiating treatment with REVLIMID® (lenalidomide) either in combination with melphalan or immediately following high-dose melphalan and autologous stem cell transplant (ASCT). Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of SPM and institute treatment as indicated.
Hepatic disorders: dose adjustments should be made in patients with renal impairment. Monitoring of liver function is recommended, particularly when there is a history of or concurrent viral liver infection or when REVLIMID® (lenalidomide) is combined with medicinal products known to be associated with liver dysfunction.
Newly diagnosed multiple myeloma patients: patients should be carefully assessed for their ability to tolerate REVLIMID® (lenalidomide) in combination, with consideration to age, ISS stage III, ECOG PS≤2 or CLcr < 60 mL/min.
Cataract: regular monitoring of visual ability is recommended.
Summary of the safety profile in multiple myeloma
Newly diagnosed multiple myeloma in patients treated with REVLIMID® (lenalidomide) in combination with low dose dexamethasone:
Newly diagnosed multiple myeloma patients treated with REVLIMID® (lenalidomide) in combination with melphalan and prednisone:
Patients with multiple myeloma who have received at least one prior therapy:
Paediatric population: REVLIMID® (lenalidomide) should not be used in children and adolescents from birth to less than 18 years.
Older people with newly diagnosed multiple myeloma: for patients older than 75 years of age treated with REVLIMID® (lenalidomide) in combination with dexamethasone, the starting dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of each 28-day treatment cycle. No dose adjustment is proposed for patients older than 75 years who are treated with REVLIMID® (lenalidomide) in combination with melphalan and prednisone.
Older people with multiple myeloma who have received at least one prior therapy: care should be taken in dose selection and it would be prudent to monitor renal function.
Patients with renal impairment: care should be taken in dose selection and monitoring of renal function is advised. No dose adjustments are required for patients with mild renal impairment and multiple myeloma. Dose adjustments are recommended at the start of therapy and throughout treatment for patients with moderate or severe impaired renal function or end stage renal disease.
Patients with hepatic impairment: REVLIMID® (lenalidomide) has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations.
Please refer to the Summary of Product Characteristics for full European Prescribing Information.
Celgene International Sàrl, located in Boudry,
This press release contains forward-looking statements, which are
generally statements that are not historical facts. Forward-looking
statements can be identified by the words "expects," "anticipates,"
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1 Palumbo A, et al. N Engl J Med. 2011;364:1046-1060.
2 Ferlay J, et al. Eur J Cancer. 2013;49:1374-1403
3 Moreau P, et al. Ann Oncol. 2013; 24 (Suppl 6): vi133-vi137
4 Moreau P, et al. Ann Oncol. 2013; 24 (Suppl 6): vi133-vi137
5 Stewart AK, et al. Blood. 2009;114:5436-5443.
6 Hoering A, et al. Blood. 2009;114:1299-1305
7 Bird JM, et al. Br
8 Attal M, et al. Blood. 2006 Nov 15;108(10):3289-94
9 Child JA, et al. N Engl J Med. 2003; 348:1875-1883
10 McCarthy PL, et al. N Engl J Med. 2012;366(19):1770-1781. CALGB is the cooperative group Cancer and Leukemia Group B (now known as Alliance).
11 Attal M, et al. N Engl J Med. 2012;366(19):1782-1791. IFM is the cooperative group Intergroupe Francophone du Myélome.
Source: Celgene International Sàrl
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