scholarly journals Final overall survival results of a randomized trial comparing bortezomib plus pegylated liposomal doxorubicin with bortezomib alone in patients with relapsed or refractory multiple myeloma

Cancer ◽  
2016 ◽  
Vol 122 (13) ◽  
pp. 2050-2056 ◽  
Author(s):  
Robert Z. Orlowski ◽  
Arnon Nagler ◽  
Pieter Sonneveld ◽  
Joan Bladé ◽  
Roman Hajek ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Randomized Trial ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Refractory Multiple Myeloma

Non Pegylated Liposomal Doxorubicin in Combination with Dexamethasone and Lenalidomide (RMD) Is Active in Advanced MM

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5742-5742
Author(s):  
Gabriele Buda ◽  
Enrico Orciuolo ◽  
Martina Rousseau ◽  
Sara Galimberti ◽  
Nadia Cecconi ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Tumour Cell ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Progression Free Survival ◽  
Free Survival ◽  
Myeloma Cells ◽  
Refractory Multiple Myeloma ◽  
Heavily Pretreated

Abstract The pharmacology of liposomal doxorubicin gives rise to a compound with major advantages that could potentially improve response and decrease toxicity. The lower toxicity, especially less cardiotoxicity, is also related to the encapsulation of doxorubicin into microscopic liposomes, which preferentially penetrate and accumulate in tumour vasculature. In addition, because myeloma cells divide slowly, the increased exposure of these cells to doxorubicin has the potential of overcoming resistance and increasing tumour cell killing capacity, theoretically resulting in improved response rates. In our hospital we treated 40 patients (24M/16F, see Table I) with of a combination regimen of lenalidomide, non pegylated liposomal doxorubicin (NPLD, Myocet®) and dexamethasone (RMD). All the patients had relapsed multiple myeloma and the majority of them were heavily pretreated (23/40 were resistant to ≥ 2 previous therapies). RMD was administered for a median of six 28-day cycles. Lenalidomide (25mg d 1-21), NPLD 40 mg/m2 d4, Dex 40 mg d1-4 and 17-20. The median age of patients was 61 years and the ORR of the combination was 58%, with 10% of patients achieving a complete or very good partial remission. In particular a high ORR (52%) resulted also in very refractory patients in third line of treatment or more. The median progression-free survival was 9.4 months, while the median overall survival was 21 months (see Table II). The most common side effect was haematological toxicity with grade neutropenia (33%), thrombocytopenia (33%) and anaemia (18%). Under thrombosis prophylaxis with aspirin 100 mg per day we observed thrombembolic complications in only in one patients. Other non haematological side effects were pain (8%), diarrhoea (8%). Neither neurotoxicity nor constitutional symptoms of grade 3/4 were found. In our study, lenalidomide in combination with NPLD and dexamethason has shown encouraging activity in heavily pretreated patients with relapsed or refractory multiple myeloma. These schemes can be additional standard of care in the treatment of patients with relapsed or refractory multiple myeloma. The addition of NPLD can play a key role in overcoming anthracycline resistance and improving the quality of response without limiting toxicity. The pharmacology of NPLD gives rise to a compound with major advantages that could potentially improve response and decrease toxicity. Because increased angiogenic activity occurs in the bone marrow of patients with multiple myeloma, this non-pegylated formulation can enhance the delivery of doxorubicin to the tumour site. In addition, because myeloma cells divide slowly, the increased exposure of these cells to doxorubicin has the potential of overcoming resistance and increasing tumour cell killing capacity, theoretically resulting in improved response rates without limiting toxicity, especially in patients who have already received at least one prior therapy. Table Characteristics of MM Patients undergoing RMD therapy Characteristics Cases Age at diagnosis (median and range) 61 (30-73) Number of patients 40 (26 M, 14 F) Stage at diagnosis Durie-Salmon (II/III) 31/40 (78%) Number of previous therapies 1 17 (42,5%) 2 10 (25%) 3 8 (20%) 45 3 (7,5%) 2 (5%) Prognostic Markers b2-microglobulin (m/L.) 2.2 (1.1 – 35)a Creatinin (mg/dl.) 0.9 (0.5 – 4.4) a Albumin (g/dl)) 4.0 (2.1 – 4.9) a Hemoglobin (mg/dl) 11.3 (5.7 – 16.4) a .aMedian (Range) Figure 1 Figure 1. Figure 2 Figure 2. Table II Progression Free Survival and Overall Survival (in months) Disclosures No relevant conflicts of interest to declare.

Effect of the combination of pegylated liposomal doxorubicin and bortezomib on time to progression (TTP) and overall survival of patients with relapsed/refractory multiple myeloma compared with bortezomib alone

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8002-8002 ◽  
Author(s):  
J. L. Harousseau ◽  
A. Nagler ◽  
P. Sonneveld ◽  
J. Bladé ◽  
R. Hajek ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Combination Therapy ◽  
Liposomal Doxorubicin ◽  
Randomized Study ◽  
Pegylated Liposomal Doxorubicin ◽  
Proteasome Inhibition ◽  
Phase Iii ◽  
Combination Group ◽  
Refractory Multiple Myeloma

8002 Background: Proteasome inhibition with bortezomib is a standard of care for patients with relapsed/refractory multiple myeloma (MM). Recently, we reported the results of an interim analysis for the DOXIL-MMY-3001 study, a large multi-national, phase III, randomized study of patients with previously treated MM demonstrating that the combination of pegylated liposomal doxorubicin (PLD) and bortezomib resulted in a 45% risk reduction of experiencing disease progression over bortezomib alone (Orlowski et al, 2006 ASH Meeting, Abstract #404). The improvement in TTP was associated with an overall survival (OS) trend favoring the combination therapy (P=0.113; hazard ratio[HR], 1.48, 95% Confidence Interval [CI], 0.91 to 2.41). We now present an updated survival analysis with a median follow up of 11 months. Methods: 646 patients at 123 centers in 18 countries received either intravenous bortezomib, 1.3 mg/m2, on days 1, 4, 8, and 11 of every 21-day cycle, or the same bortezomib regimen with PLD, 30 mg/m2, on day 4. Results: As previously reported, median TTP was improved from 6.5 months for bortezomib alone to 9.3 months for the PLD+bortezomib combination (P=0.000004; HR, 1.82; 95% CI, 1.41 to 2.35). The complete+partial response rate was 43% for bortezomib and 48% for PLD+bortezomib (P=0.251). Median duration of response was increased from 7.0 months (95% CI, 5.9 to 8.3) to 10.2 months (95% CI, 10.2 to 12.9) with combination therapy (p=0.0008). Updated OS analysis showed PLD+bortezomib significantly improved OS (p<0.05; HR, 1.41, 95% CI, 1.002 to1.97). Both groups received a median of 5 cycles of treatment. The safety profile of the combination was consistent with the known toxicities of the two agents. Grade 3/4 adverse events were more frequent in the combination group primarily due to increase in myelosuppression and GI toxicities. Conclusions: PLD with bortezomib is superior to bortezomib monotherapy for the treatment of patients with relapsed/refractory MM. [Table: see text]

Early Normalization of Serum Free Light Chain Is Associated with Prolonged Time to Progression Following Bortezomib ± Pegylated Liposomal Doxorubicin Treatment of Relapsed/Refractory Multiple Myeloma.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2735-2735 ◽  
Author(s):  
Robert Orlowski ◽  
Heather Sutherland ◽  
Joan Bladé ◽  
Jesús San Miguel ◽  
Roman Hájek ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Light Chain ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Response Rates ◽  
Free Light Chain ◽  
Time To Progression ◽  
Serum Free ◽  
Refractory Multiple Myeloma ◽  
Serum Free Light Chain

Abstract Multiple myeloma (MM), like other monoclonal gammopathies, frequently causes impairment of the κ/λ serum free light chain (sFLC) ratio. Based on a short serum half-life of FLC as compared to the complete immunoglobulin (hours versus days), early normalization of κ/λ could predict for response to treatment. As part of a randomized, controlled study, we examined the association between normalization of the κ/λ ratio after one or two 21-day cycles of treatment with bortezomib (B) ± pegylated liposomal doxorubicin (PLD) among patients with relapsed/refractory multiple myeloma. Patients with ≥1 prior therapy were randomized to receive PLD 30 mg/m2 on day 4 and B 1.3 mg/m2 on days 1, 4, 8, and 11, or B alone for up to eight 21-day cycles, or at least 2 cycles beyond complete response (CR) or optimal response, unless disease progression or unacceptable toxicities occurred (Orlowski, JCO 2007). κ/λ measurements were carried out prior to the start of therapy and at the end of each cycle through the entire study period using an immunoassay (Freelite, The Binding Sites, Birmingham, UK). Serial sFLC κ/λ measurements were available on sera from 487 patients with baseline values out of a total of 646 study patients. At baseline, 458/487 patients (94%) had an abnormal κ/λ ratio (<0.26 or >1.65). The percentage of patients with normal κ/λ ratio increased from 6% at baseline to 12% after cycle 1, 17% after cycle 2 and 23% by the end of the study. Among patients with a normal κ/λ ratio after cycle 1 (n=54), the median time to progression (TTP) was 345 days compared to 225 days in patients with abnormal ratios (n=395, p=0.0005, HR=0.47 favoring normalization). Following cycle 2, TTP was 325 days vs. 224 days (p≤0.001) in patients with normal (n=72) vs. abnormal (n=348) ratios, respectively. Additionally, patients with normalized sFLC ratios showed significantly higher overall response rates as compared to those with persistently abnormal ratios (≥ partial response [PR] 73% vs. 47%, p=0.001 following cycle 1, and 77% vs. 48%, p<0.0001 following cycle 2, respectively). Similarly, CR + very good PR rates were significantly higher among patients with normalized sFLC ratios after cycles 1 and 2 (p<0.0001 and p<0.001 respectively). As reported previously, both treatments, B + PLD and B alone, were well tolerated (Orlowski, JCO 2007). Normalization of the sFLC ratio as early as after cycle 1 of B + PLD, or B alone, was associated with a prolonged TTP and higher response rates. Additional analyses are undertaken to evaluate whether Freelite data: predict treatment outcome earlier than electrophoresis, and correlate with 24-hour urine M-protein.

Randomized Phase III Study of Pegylated Liposomal Doxorubicin Plus Bortezomib Compared With Bortezomib Alone in Relapsed or Refractory Multiple Myeloma: Combination Therapy Improves Time to Progression

2007 ◽  
Vol 25 (25) ◽  
pp. 3892-3901 ◽  
Author(s):  
Robert Z. Orlowski ◽  
Arnon Nagler ◽  
Pieter Sonneveld ◽  
Joan Bladé ◽  
Roman Hajek ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Combination Therapy ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
International Study ◽  
Phase Iii ◽  
Combination Group ◽  
Time To Progression ◽  
Refractory Multiple Myeloma ◽  
Grade 3

PurposeThis phase III international study compared the efficacy and safety of a combination of pegylated liposomal doxorubicin (PLD) plus bortezomib with bortezomib monotherapy in patients with relapsed or refractory multiple myeloma.Patients and MethodsSix hundred forty-six patients were randomly assigned to receive either intravenous bortezomib 1.3 mg/m2on days 1, 4, 8, and 11 of an every 21-days cycle, or the same bortezomib regimen with PLD 30 mg/m2on day 4.ResultsMedian time to progression was increased from 6.5 months for bortezomib to 9.3 months with the PLD + bortezomib combination (P = .000004; hazard ratio, 1.82 [monotherapy v combination therapy]; 95% CI, 1.41 to 2.35). The 15-month survival rate for PLD + bortezomib was 76% compared with 65% for bortezomib alone (P = .03). The complete plus partial response rate was 41% for bortezomib and 44% for PLD + bortezomib, a difference that was not statistically significant. Median duration of response was increased from 7.0 to 10.2 months (P = .0008) with PLD + bortezomib. Grade 3/4 adverse events were more frequent in the combination group (80% v 64%), with safety profiles consistent with the known toxicities of the two agents. An increased incidence in the combination group was seen of grade 3/4 neutropenia, thrombocytopenia, asthenia, fatigue, diarrhea, and hand-foot syndrome.ConclusionPLD with bortezomib is superior to bortezomib monotherapy for the treatment of patients with relapsed or refractory multiple myeloma. The combination therapy is associated with a higher incidence of grade 3/4 myelosuppression, constitutional symptoms, and GI and dermatologic toxicities.

Effect of Disease Stage and Time Since Diagnosis on Time to Progression for Pegylated Liposomal Doxorubicin + Bortezomib vs Bortezomib Alone in Relapsed or Refractory Multiple Myeloma.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2740-2740
Author(s):  
Heather J. Sutherland ◽  
Joan Blade ◽  
Jesus San Miguel ◽  
Arnon Nagler ◽  
Pieter Sonneveld ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Staging System ◽  
Risk Groups ◽  
Phase Iii ◽  
Disease Stage ◽  
Time To Progression ◽  
Total Study Population ◽  
Refractory Multiple Myeloma

Abstract A recent report of a phase III randomized trial with pegylated liposomal doxorubicin (PLD)+bortezomib vs. bortezomib alone in relapsed or refractory multiple myeloma (RRMM) demonstrated improved time to progression (TTP) with PLD+bortezomib (Orlowski, JCO 2007). The present post-hoc analyses evaluated the efficacy of PLD+bortezomib according to International Staging System (ISS) disease stage, and time since initial myeloma diagnosis (TSD). Patients with ≥1 prior therapy were randomized to receive PLD at 30 mg/m2 on day 4 and bortezomib at 1.3 mg/m2 on days 1, 4, 8, and 11, or bortezomib alone for up to eight 21-day cycles, or at least 2 cycles beyond CR, or optimal response unless disease progression or unacceptable toxicities occurred. The improved TTP reported previously with PLD+bortezomib over bortezomib alone in the total study population was also observed in the higher risk groups based on disease stage (ISS 2 & 3; Table). TTP was also significantly longer with PLD+bortezomib vs. bortezomib for TSD >2 yrs despite more protracted disease. The therapeutic advantage of prolonged TTP with the PLD+bortezomib combination was maintained consistently across subgroups (heterogeneity tests: ISS 1 vs. 2 vs. 3, p=0.407; TSD ≤2 yrs. vs. >2 yrs., p=0.946). Incidence of grade 3/4 neuropathies was low (<10%) in the two treatment arms in all subgroups. PLD-related hand-foot syndrome was also <10% in all PLD+bortezomib subgroups. Despite high-grade disease or protracted disease history, the PLD+bortezomib combination shows significantly improved TTP as compared to bortezomib alone. Also, the combination therapy was well-tolerated.

The Effect of Bone Marrow Involvement on the Efficacy of Pegylated Liposomal Doxorubicin + Bortezomib Vs Bortezomib Alone in Patients with Relapsed/Refractory Multiple Myeloma

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5192-5192
Author(s):  
Jatin Shah ◽  
Joan Blade ◽  
Jesus San Miguel ◽  
Pieter Sonneveld ◽  
Donghan Luo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Bone Marrow ◽  
Liposomal Doxorubicin ◽  
Bone Marrow Involvement ◽  
Pegylated Liposomal Doxorubicin ◽  
Tumor Burden ◽  
Phase Iii ◽  
Rank Test ◽  
Time To Progression ◽  
Refractory Multiple Myeloma

Abstract Background: Patients with relapsed/refractory multiple myeloma (RRMM) often have a large tumor burden with significant bone marrow involvement, conferring a poor prognostic feature. Those patients with significant bone marrow involvement may benefit from combination regimens with increased activity. Orlowski et al. reported a phase III randomized trial with pegylated liposomal doxorubicin (PLD) + bortezomib (B) vs. B alone in RRMM, which demonstrated improved time to progression (TTP) with the combination of PLD+B. (Orlowski, JCO 2007) We investigated the effect of bone marrow involvement on overall response rates and time to progression (TTP) of PLD+ B versus B alone in patients with RRMM. Methods: Eligible patients were randomized to bolus IV B 1.3 mg/m2 on days 1, 4, 8, and 11 of each 3-week cycle (n=322) or to the same B regimen plus IV PLD 30 mg/m2 on day 4 (n=324) of each cycle. The subsets of patients with bone marrow involvement and those with &gt;30% involvement were analyzed retrospectively. Results: A total of 379 patients had bone marrow involvement and 349 patients had &gt;30% bone marrow involvement compared with 259 with no bone marrow involvement. Time to disease progression (TTP) and complete response (CR) + partial response (PR) rates for PLD+B vs B alone in patients with or without any bone marrow involvement or &gt;30% bone marrow involvement are listed in the table. PLD+B B P valueb Hazard Ratioc a. Based on Kaplan-Meier product-limit estimates. b. Based on stratified Log-rank test. c. A hazard ratio &gt;1 indicates an advantage for PLD+B. d. Cochran-Mantel-Haenszel test controlling for Beta2 microglobulin and response to initial treatment. No bone marrow involvement, N 132 127 TTP, Median days (95% CI)a 251 (212, 282) 198 (162, 227) 0.0134 1.69 (1.11, 2.57) Total CR+PR, n/evaluable (%) 49/118 (42) 43/124 (35) 0.2887d Any bone marrow involvement, N 188 191 TTP 311 (264, 354) 197 (169, 222) .0001 1.91 (1.37, 2.67) Total CR+PR 94/183 (51) 88/182 (48) .5187d &gt;30% bone marrow involvement, N 172 177 TTP 276 (221, 415) 183 (158, 211) .0005 1.83 (1.30, 2.58) Total CR+PR 82/168 (49) 69/170 (41) .1446d Regardless of bone marrow involvement or extent of bone marrow involvement, there was a statistically significant benefit in TTP for PLD+B vs. B alone. Safety profiles for the 2 regimens in the subsets of patients with or without bone marrow involvement were consistent with the known toxicities of the 2 agents. Conclusions: These data suggest that the combination of PLD+B is an active salvage therapy and superior to B alone in patients with RRMM, regardless of the presence or extent of bone marrow involvement. Patients with significant bone marrow involvement and associated poor risk due to increased tumor burden may benefit from the addition of PLD.

The Effect of Paraprotein Heavy Chain and Free Light Chain Types on the Efficacy of Pegylated Liposomal Doxorubicin + Bortezomib Versus Bortezomib Alone in Patients with Relapsed/Refractory Multiple Myeloma

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5190-5190
Author(s):  
Jatin Shah ◽  
Joan Blade ◽  
Pieter Sonneveld ◽  
Jesus San Miguel ◽  
Donghan Luo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Heavy Chain ◽  
Light Chain ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Complete Response ◽  
Phase Iii ◽  
Rank Test ◽  
Absolute Increase ◽  
Refractory Multiple Myeloma

Abstract Background: Many factors influence the choice of salvage therapy in relapsed/refractory multiple myeloma (RRMM), including various disease characteristics such as light chain and heavy chain subtypes. Patients with light chain only myeloma are a biologically and phenotypically distinct subset of patients from those with IgG, IgA, IgM, or IgD disease. Evidence exists that the presence of different paraprotein heavy and light chain subtypes may affect treatment outcomes. We investigated the effect of the presence of paraprotein heavy and light chain types on the efficacy and safety of pegylated liposomal doxorubicin (PLD) + bortezomib (B) versus B alone based on the phase III randomized trial of PLD+B vs. B alone in RRMM, which demonstrated improved time to progression (TTP) with PLD+B (Orlowski, JCO 2007). Methods: Eligible patients were randomized to bolus IV B 1.3 mg/m2 on days 1, 4, 8, and 11 of each 3-week cycle (n=322) or to the same B regimen plus IV PLD 30 mg/m2 on day 4 (n=324) of each cycle. The subsets of patients with light chain and heavy chain multiple myeloma subtypes were analyzed retrospectively. Results: The presence of light chain myeloma was observed in 77 patients. Few patients had IgM/IgD subtype myeloma (4 and 6 patients, respectively), while the majority of patients had IgG (n=379) or IgA (n=265) subtypes. Time to disease progression (TTP) and complete response (CR) + partial response (PR) rates for PLD+B vs B alone in patients with light chain, IgG, and IgA myeloma subtypes are listed in the table. PLD+B B P valueb Hazard Ratioc a. Based on Kaplan-Meier product-limit estimates. b. Based on stratified Log-rank test. c. A hazard ratio &gt;1 indicates an advantage for PLD+B. d. Cochran-Mantel-Haenszel test controlling for Beta2 microglobulin and response to initial treatment. Light chain, N 40 37 TTP, Median days (95% CI)a 276 (171, n/a) 117 (85, 173) .003 3.09 (1.42, 6.73) Total CR+PR, n/evaluable (%) 22/39 (56) 10/33 (30) .030d IgG subtype, N 182 197 TTP 282 (221, 331) 199 (170, 222) .002 1.67 (1.20, 2.31) Total CR+PR 70/173 (41) 81/194 (42) .915d IgA subtype, N 88 77 TTP 250 (218, n/a) 205 (177, 236) .506 1.22 (0.68, 2.18) Total CR+PR 46/79 (58) 39/72 (54) .723d Results showed that the combination of PLD+B had significant benefit over B alone in TTP (PLD+B led to longer TTP than B alone) for IgG paraprotein and light chain subtypes. Safety profiles for the 2 regimens in these subsets of patients with heavy or light chain myeloma were consistent with the known toxicities of the 2 agents used. Conclusions: These data demonstrate that the combination of PLD+B is an important treatment option in patients with RRMM. Patients with light chain only disease had the largest incremental benefit from the addition of PLD with an absolute increase in TTP of 159 days as well as an increase in the overall response rate from 30% to 56%.

Clinical Efficacy of Pegylated Liposomal Doxorubicin, Vincristine and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5212-5212
Author(s):  
Wen Wu ◽  
Xiaodong Gao ◽  
Lan Xu ◽  
Hua Yan ◽  
Zhixiang Shen ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Partial Response ◽  
Adverse Events ◽  
Median Time ◽  
Liposomal Doxorubicin ◽  
Gastrointestinal Symptoms ◽  
Pegylated Liposomal Doxorubicin ◽  
High Response Rate ◽  
Newly Diagnosed

Abstract Object: To investigate the short-term and long-term efficacy and toxicity of pegylated liposomal doxorubicin, vincristine and dexamethasone (DVD) in patients with newly diagnosed multiple myeloma (MM). Methods: Twenty-five patients (13 males, 12 females, median age 55 years) with newly diagnosed multiple myeloma were treated with pegylated liposomal doxorubicin 40 mg/m2 and vincristine 2 mg intravenously on day 1 plus dexamethasone 40 mg intravenously or orally on days 1–4 (DVD) for median 4.5 (2–8) cycles. Treatment was repeated every 4 weeks. Response was evaluated according to the International Uniform Response Criteria for Multiple Myeloma (2006) before initiation of each course. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria, version 3.0. Results: After 4.5 (2–8) courses of the median cycles, clinical response was observed in 20 patients (80%), including complete response in 4 (16%), very good partial response in 3 (12%), partial response in 10 (40%), minimal response in 3 (12%) and stable disease in 2 (8%). The median time to initial response was 1.2 months and the median time to best response was 4 months. After 25 (2–50) months of median follow-up, the median progression-free survival was 20 months, while the median overall survival has not yet been reached. The overall survival rate was 72% (18/25). The most common adverse events were gastrointestinal symptoms (nausea and vomiting in 10, constipation in 9 patients), neutropenia (7 patients), anemia (6 patients) and thrombocytopenia (4 patients). DVD was associated with more hand-foot syndrome (4 patients) and mucitis (2 patients). Conclusions: DVD scheme is an effective therapy with a high response rate and manageable toxicities for patients with newly diagnosed multiple myeloma.

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