Randomized comparison of dexamethasone combined with melphalan <i>versus</i> melphalan with prednisone in the treatment of elderly patients with multiple myeloma

Hernández, JoséM.; García‐Sanz, Ramón; Golvano, Estibaliz Zamarreño; Bladé, Joan; Fernández-Calvo, J.; Trujillo, J.; Soler, Josep Pubill; Gardella, Santiago; Carbonell, Félix; Flores-Mateo, Gemma; Miguel, Jesús F. San

doi:10.1111/j.1365-2141.2004.05186.x

Cited by 73 publications

(50 citation statements)

References 19 publications

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“…In both studies also, response rates achieved by M-DEX were superior at 12 months to those achieved by MP. 5 The disease control achieved by DEX and DEX-IFN was clearly inferior to that achieved by M-containing treatments (MP and M-DEX) in terms of PFS and MM-related deaths in the first 3 months of treatment (Table 4; Figure 1B). Notably, 12 of 248 patients receiving DEX or DEX-IFN had MM progression and death in the first 3 months, whereas it was the case for only 1 of 240 patients receiving MP or M-DEX (P ϭ .003).…”

Section: Discussionmentioning

confidence: 99%

“…In 1995 the M-DEX combination had not been evaluated in a randomized study, and only one recent publication has presented a comparison between MP and M-DEX. 5 The aim of the IFM 95-01 study was to compare, in elderly patients ineligible for high-dose therapy, MP, M-DEX, DEX alone, and DEX-IFN. This study represents the largest randomized trial comparing MP with various DEX regimens before the availability of new drugs such as thalidomide, bortezomib, or lenalidomide.…”

Section: Discussionmentioning

confidence: 99%

“…Only one recent study has compared melphalan and dexamethasone (M-DEX) with MP and has concluded that MP should remain the reference for comparison of new treatments involving innovative drugs. 5 Limited trial data are also available regarding the dexamethasone-interferon alpha (DEX-IFN) combination. In a small nonrandomized study of newly diagnosed patients, the addition of IFN (3 million units [MU]/m 2 /d) to DEX achieved results similar to those with DEX alone.…”

Section: Introductionmentioning

confidence: 99%

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Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy

Facon

Mary

Pégourie

et al. 2006

Blood

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100

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Dexamethasone alone increases life expectancy in patients with relapsed multiple myeloma (MM); however, no large randomized study has compared dexamethasone and dexamethasone-based regimens with standard melphalanprednisone in newly diagnosed MM patients ineligible for high-dose therapy. In the Intergroupe Francophone du My-é lome (IFM) 95-01 trial, 488 patients aged 65 to 75 years were randomized between 4 regimens of treatment: melphalan-prednisone, dexamethasone alone, melphalandexamethasone, and dexamethasoneinterferon alpha. Response rates at 6 months (except for complete response) were significantly higher among patients receiving melphalan-dexamethasone, and progression-free survival was significantly better among patients receiving melphalan (P < .001, for both comparisons), but there was no difference in overall survival between the 4 treatment groups. Moreover, the morbidity associated with dexamethasone-based regimens was significantly higher than with melphalan-prednisone, especially for severe pyogenic infections in the melphalandexamethasone arm and hemorrhage, severe diabetes, and gastrointestinal and

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy

Facon

Mary

Pégourie

et al. 2006

Blood

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100

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“…However, MD was also associated with a greater risk of severe toxicities, most notably severe pyogenic infections including pulmonary infections and septicemia, in agreement with prior such studies. 23 Moreover, the higher response rate with MD did not translate into either a significantly better median time to progression or median overall survival. Thus, the authors concluded that MP remained the standard of care for induction therapy in this patient population and that it should be the starting point for the development of future combinations.…”

Section: Initial Therapy With Mp-based Regimensmentioning

confidence: 99%

Initial Therapy of Multiple Myeloma Patients Who Are Not Candidates for Stem Cell Transplantation

Orłowski¹

2006

Hematology

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Multiple myeloma patients deemed to not be candidates for high-dose therapy followed by stem cell rescue who nonetheless need chemotherapy have traditionally received an oral regimen combining melphalan and prednisone. With the advent of novel agents, however, such as immunomodulatory drugs and proteasome inhibitors that are active in the relapsed/refractory setting, there has been an impetus to incorporate these new options into front-line therapy. Several phase II studies have recently revealed that addition of either thalidomide, lenalidomide, or bortezomib to melphalan and prednisone increased the overall and complete response rates, albeit at the cost of some increased toxicity. Randomized phase III studies of melphalan and prednisone with thalidomide have already shown that, compared to melphalan and prednisone alone, the three-drug regimen prolonged time to progression and overall survival in this population, thereby defining a new standard of care. Moreover, our increasing knowledge of the molecular role that cytogenetic abnormalities play in the biology of multiple myeloma and our growing chemotherapeutic armamentarium are beginning to allow us to rationally select therapies based on these characteristics of each patient's disease. Such a risk-and molecular-adapted strategy to the therapy of multiple myeloma promises to revolutionize and personalize our care of these patients and bring us closer to a cure for this disease.Using the diagnostic criteria recommended by the International Working Group, patients with multiple myeloma are classified as having either asymptomatic or symptomatic (Table 1) disease. 1 The latter population, generally considered candidates for a chemotherapy-based intervention, are then further divided into those who either are or are not eligible for high-dose chemotherapy followed by stem cell rescue. 2 Criteria that are weighed to help make this second distinction have generally included age, performance status, and co-morbid medical conditions. 2 There is some variability in these parameters and how they are applied, since studies examining stem cell transplantation have used different criteria. In regard to age, for example, which is the most objective of these measures, initial studies tended to enroll patients younger than 65 years of age, 3 while more recent studies suggest that transplant is safe in at least some who are over the age of 70 (for example 4,5 ). On the other hand, data suggesting that patients with poor-risk chromosomal features have a short time to progression after autologous transplantation have led to suggestions that even younger patients with these abnormalities may not be candidates for standard approaches. Nonetheless, as little as two years ago, there was general agreement that the standard of care for patients who were not eligible for transplantation and yet needed chemotherapy was melphalan

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“…12 Time to alternative treatment (the time from inclusion in the study to initiation of an alternative myeloma therapy) was analyzed. To evaluate the influence of known myeloma prognostic factors on time to progression, a univariate analysis was conducted (log-rank for categorical variables, coded into categories with presumed better-to-worse prognosis).…”

Section: Assessmentsmentioning

confidence: 99%

Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: updated time-to-events results and prognostic factors for time to progression

Mateos¹,

Hernández²,

Hernández³

et al. 2008

Haematologica

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BackgroundNew treatment options offering enhanced activity in elderly, newly diagnosed patients with multiple myeloma are required. One strategy is to combine melphalan and prednisone with novel agents. We previously reported an 89% response rate, including 32% complete responses and 11% near complete responses, in our phase 1/2 study of bortezomib plus melphalan and prednisone (VMP) in 60 newly diagnosed multiple myeloma patients with a median age of 75 years. Here, we report updated time-to-events data and the impact of poor prognosis factors on outcome.

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Randomized comparison of dexamethasone combined with melphalan versus melphalan with prednisone in the treatment of elderly patients with multiple myeloma

Cited by 73 publications

References 19 publications

Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy

Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy

Initial Therapy of Multiple Myeloma Patients Who Are Not Candidates for Stem Cell Transplantation

Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: updated time-to-events results and prognostic factors for time to progression

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