GEM2005 trial update comparing VMP/VTP as induction in elderly multiple myeloma patients: do we still need alkylators?

Mateos, María‐Victoria; Oriol, Albert; Martínez‐López, Joaquín; Teruel, Ana-Isabel; Guía, Ana López de la; López, Javier; Bengoechea, Enrique Garcíá; Pérez, Montserrat; Martínez, Rafael; Palomera, Luis; Arriba, Felipe de; González, Yolanda; Hernández, José; Granell, Miquel; Bello, José-Luis; Bargay, Joan; Peñalver, Francisco‐Javier; Martín-Mateos, María-Luisa; Paiva, Bruno; Montalbán, María-Ángeles; Bladé, Joan; Lahuerta, Juan-José; Miguel, Jesús F. San

doi:10.1182/blood-2014-05-573733

Cited by 97 publications

(81 citation statements)

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“…[1][2][3] Immunomodulatory drugs (IMiDs; thalidomide and lenalidomide) and proteasome inhibitors (PIs; bortezomib) significantly improved survival in transplant-eligible and -ineligible patients. [4][5][6][7][8][9][10][11][12][13][14][15] Given the survival rate in transplant-ineligible patients and the substantial toxicity of high-dose melphalan (melphalan 200 mg/m 2 [MEL200]), the role of ASCT has become an area of debate, and the comparison with less toxic, oral novel agentsbased treatments a high research priority. Cyclophosphamide-lenalidomide-dexamethasone (CRD) showed a partial response rate of 85% and a good safety profile.…”

Section: Text Word Count (Max 3000): 2999 Introductionmentioning

confidence: 99%

Chemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: a randomised, multicentre, phase 3 trial

Gay

Oliva

Petrucci

et al. 2015

The Lancet Oncology

284

252

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AperTO -Archivio Istituzionale Open Access dell'Università di TorinoChemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: A randomised, multicentre, phase 3 trial / Gay, Francesca; Oliva, Stefania; Petrucci, Maria Teresa; Conticello, Concetta; Catalano, Lucio; Corradini, Paolo; Siniscalchi, Agostina; Magarotto, Valeria; Pour, Ludk; Carella, Angelo; Malfitano, Alessandra; Petrò, Daniela; Evangelista, Andrea; Spada, Stefano; Pescosta, Norbert; Omedè, Paola; Campbell, Philip; Liberati, Anna Marina; Offidani, Massimo; Ria, Roberto; Pulini, Stefano; Patriarca, Francesca; Hajek, Roman; Spencer, Andrew; Boccadoro, Mario; Palumbo, Antonio. -In: LANCET ONCOLOGY. -ISSN 1470-ISSN -2045-ISSN . -16:16(2015, pp. 1617-1629. Original Citation:Chemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: A randomised, multicentre, phase 3 trial This is an author version of the contribution published on:Questa è la versione dell'autore dell'opera: [Lancet Oncol. 2015 Dec;16(16):1617-29. doi: 10.1016/S1470-2045 Background. High-dose melphalan plus autologous stem-cell transplantation (MEL200-

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Section: Text Word Count (Max 3000): 2999 Introductionmentioning

confidence: 99%

Chemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: a randomised, multicentre, phase 3 trial

Gay

Oliva

Petrucci

et al. 2015

The Lancet Oncology

284

252

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“…25,26 In summary, the results of this phase 2 trial of BVP in untreated MM patients are encouraging, although the conclusions should be interpreted with caution due to the sample size and the single-arm, non-randomized design. The regimen had an acceptable toxicity profile.…”

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confidence: 85%

Bendamustine, bortezomib and prednisone for the treatment of newly diagnosed multiple myeloma patients: results of a prospective phase 2 Spanish/Pethema trial

Mateos

Oriol²,

Rosiñol

et al. 2015

Haematologica

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© F e r r a t a S t o r t i F o u n d a t i o nBendamustine in newly diagnosed myeloma haematologica | 2015; 100(8) 1097dexamethasone is not only another standard of care, but also a new backbone to which novel drugs can be added. 8Bendamustine is a unique bifunctional alkylating agent with proven activity in MM.9 Although it appears to be effective as monotherapy, it is usually combined with other agents, proteasome inhibitors or immunomodulatory drugs. It has an acceptable toxicity profile, and its suitability for patients with renal impairment is of particular note. 10 Although it is commonly used in the relapse setting, bendamustine in combination with prednisone 11 has been approved in Europe in the upfront setting to treat MM patients who are not candidates for HDT-ASCT and who cannot receive thalidomide or bortezomib because they have peripheral neuropathy. The approval was based on a randomized trial in which bendamustine plus prednisone proved to be better than melphalan plus prednisone in terms of complete response rate and time-totreatment failure. 12 The combination of bendamustine plus bortezomib and dexamethasone has been tested in seven phase 1-2 trials conducted in relapsed or relapsed and refractory patients, in whom it yielded overall response rates of 48%-85%, with an acceptable safety profile. 9,13 In newly diagnosed MM patients, two studies conducted in transplant-ineligible patients have tested this combination administering bortezomib in the conventional, twice-weekly schedule. The first of these studies included 44 patients, and preliminary results indicated an overall response rate of 85%. 14 The second was a retrospective study conducted in patients with normal or impaired renal function. The overall response rate was 82% and there were no differences between patients with normal/mildly impaired renal function and those with moderate/severe renal impairment. 15 In this article, we report the efficacy and safety results of the combination of bendamustine plus bortezomib and prednisone (BVP) in newly diagnosed MM patients, but giving bortezomib twice a week during the first cycle and weekly thereafter. This is the first trial conducted in newly diagnosed MM patients which included transplant-eligible and transplant-ineligible patients, and provided a singular opportunity to evaluate the effect of bendamustine on stem cell collection and its efficacy as part of an induction regimen followed by transplantation. Methods Patients and study designPatients with newly diagnosed, untreated, symptomatic, measurable MM were included in this open-label, phase 2 study carried out at 16 centers throughout Spain. All patients received the combination based on BVP: the first cycle consisted of bendamustine 90 mg/m 2 given intravenously (IV) on days 1 and 4, in combination with bortezomib 1.3 mg/m 2 given IV on days 1, 4, 8, 11, 22, 25, 29 and 32 and prednisone 60 mg/m 2 given orally on days 1 to 4. In the following cycles, bendamustine was given on days 1 and 8, and bortezomib on days 1, 8, 1...

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“…For this patient, early use of autologous transplant will provide the maximum benefit of high-dose melphalan, a benefit that appears marginal in patients with P53-deleted disease. Maintenance therapy incorporating both subcutaneous bortezomib and low-dose lenalidomide until the development of toxicity or progression extrapolates the survival benefits from CALGB 100104 33 and follows the lead of Spanish 46 and Italian phase III trials. All experts would choose such a combination induction therapy and then proceed to melphalanbased high-dose therapy and autologous stem cell transplant as a current standard of care for this patient's age and risk group.…”

Section: Expert Opinionmentioning

confidence: 99%

High-Risk Myeloma: When To Transplant—Or Not

Eicher¹,

Lonial²,

Cavallo³

et al. 2014

Seminars in Oncology

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GEM2005 trial update comparing VMP/VTP as induction in elderly multiple myeloma patients: do we still need alkylators?

Abstract: Key Points Melphalan, in combination with bortezomib, should be maintained as one of the standards of care for the treatment of elderly MM patients. Complete response and particularly flow complete response should be an important goal in the treatment of elderly myeloma patients.

Cited by 97 publications

References 12 publications

Chemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: a randomised, multicentre, phase 3 trial

Chemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: a randomised, multicentre, phase 3 trial

Bendamustine, bortezomib and prednisone for the treatment of newly diagnosed multiple myeloma patients: results of a prospective phase 2 Spanish/Pethema trial

High-Risk Myeloma: When To Transplant—Or Not

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