Results of a phase II trial of intense androgen deprivation therapy prior to radical prostatectomy (RP) in men with high-risk localized prostate cancer (PC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5503-5503
Author(s):  
Rana R. McKay ◽  
Wanling Xie ◽  
Fiona M. Fennessy ◽  
Zhenwei Zhang ◽  
Rosina Lis ◽  
...  
Keyword(s):  
High Risk ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Residual Disease ◽  
Pathologic Complete Response ◽  
Pathologic Response ◽  
Androgen Deprivation ◽  
Increased Risk ◽  
Grade 3 ◽  
The Impact

5503 Background: Patients with high-risk localized PC have an increased risk of recurrence and death despite treatment. Abiraterone acetate (AA), a potent CYP17 inhibitor, and apalutamide, a next generation anti-androgen, have each demonstrated improved overall survival in metastatic PC. In this multicenter randomized phase II trial we investigate the impact of intense androgen deprivation on RP pathologic response (NCT02903368). Methods: Eligible patients had a Gleason score ≥4+3=7, PSA >20 ng/mL or T3 disease (by prostate MRI) and lymph node <20 mm. During Part 1 of the study, patients were randomized 1:1 to AA + prednisone + apalutamide + leuprolide (APAL) or AA + prednisone + leuprolide (APL) for 6 cycles (1 cycle=28 days) followed by RP. All RPs underwent central pathology review. The primary endpoint was the rate of a pathologic complete response (pCR) or minimum residual disease (MRD, tumor ≤5 mm). Secondary endpoints include PSA response, surgical staging at RP, positive margin rate, and safety. Results: 118 patients were enrolled at four sites. Median age was 61 (range 46-72) years. The majority of patients had NCCN high-risk disease [n=111, 94%; T3 n=73 (62%), Gleason 8-10 n=84 (71%), PSA >20 ng/mL n=28 (24%)]. 114 (97%) patients completed 6 therapy cycles followed by RP. Median PSA nadir was <0.01 versus 0.02 ng/mL and time to nadir was 4.2 versus 4.6 months in the APAL and APL arms, respectively. RP outcomes are displayed in Table. The combined pCR or MRD rate was 21.8% in the APAL arm and 20.3% in the APL arm (p=0.85). 13 (11%) patients (8 in APAL; 5 in APL) experienced grade 3 treatment-related adverse events (TrAEs). The most common grade 3 TrAEs were hypertension (5%), elevated ALT (3%) and elevated AST (3%). No grade 4 or 5 TrAE was reported. Conclusions: Intense neoadjuvant hormone therapy followed by RP in men with high-risk PC resulted in favorable pathologic responses (<5 mm residual tumor) in 21% of patients. Pathologic responses were similar between the treatment arms. Follow-up is necessary to evaluate the significance of a pathologic response on recurrence rates. Part 2 of this trial will investigate the impact of an additional 12 months of APAL post-RP on biochemical recurrence. A phase 3 trial investigating neoadjuvant apalutamide + leuprolide prior to RP is ongoing. Clinical trial information: NCT02903368 . [Table: see text]

Results of a phase II trial of neoadjuvant abiraterone + prednisone+ enzalutamide + leuprolide (APEL) versus enzalutamide + leuprolide (EL) for patients with high-risk localized prostate cancer (PC) undergoing radical prostatectomy (RP).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 79-79 ◽  
Author(s):  
Rana R. McKay ◽  
Wanling Xie ◽  
Rosina Lis ◽  
Huihui Ye ◽  
Zhenwei Zhang ◽  
...  
Keyword(s):  
High Risk ◽  
Hormone Therapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Residual Disease ◽  
Pathologic Complete Response ◽  
Recurrence Rates ◽  
Increased Risk ◽  
Grade 3 ◽  
The Impact

79 Background: Patients with high-risk PC have an increased risk of recurrence and mortality despite therapy. Abiraterone, a CYP17 inhibitor, and enzalutamide, a next generation anti-androgen, have demonstrated improved overall survival in metastatic PC. In this multicenter randomized phase II trial, we evaluate the impact of second generation hormone therapy on RP pathologic outcomes. Methods: Eligible patients had biopsy Gleason score ≥4+3=7, PSA >20 ng/mL or cT3 disease (by prostate MRI). Lymph node were require to be <20 mm. Patients were randomized 2:1 to APE:EL for 6 cycles (24 weeks) followed by RP. All RPs underwent central pathology review. The primary endpoint was the rate of pathologic complete response (pCR) or minimum residual disease (MRD, tumor ≤5 mm). Secondary endpoints include PSA response, surgical staging at RP, positive margin rate, and safety. Results: 75 patients were enrolled at four sites: DFCI/BWH (n=55), BIDMC (n=11), UW (n=5), JHU (n=4). Median age was 62 years. Most patients had NCCN high-risk disease [n=66, 88%; cT3 n=21 (28%), Gleason 8-10 n=59 (79%), PSA >20 ng/mL n=17 (23%)]. All patients completed 6 cycles followed by RP. Median PSA nadir was 0.03 and 0.02 ng/mL and time to nadir was 3.7 and 4.6 months in the APEL and EL arms, respectively. The combined pCR or MRD rate was 30% (n=15/50) in the APEL arm and 16% (n=4/25) in the EL arm. The response difference was 14% (80% CI -3%-30%, p=0.263). 15 patients (14 in APEL; 1 in EL) had grade 3 adverse events (AEs). The most common grade 3 AEs were hypertension (n=7) and ALT increase (n=5). No grade 4-5 AEs occurred. Conclusions: Neoadjuvant hormone therapy plus RP in men with high-risk PC resulted in favorable pathologic responses (≤5 mm residual tumor) in 16-30% with a trend towards improved pathologic outcomes with APEL and acceptable safety profile. Follow-up is necessary to evaluate the impact of therapy on recurrence rates. Clinical trial information: NCT02268175. [Table: see text]

A randomised phase II trial assessing the impact of the addition of gefitinib to the combination of radiotherapy and short-term maximal androgen blockage in high-risk localised prostate cancer: Safety evaluation

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14613-14613
Author(s):  
P. Thirion
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Skin Rash ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Safety Evaluation ◽  
Significant Difference ◽  
Grade 3 ◽  
Lh Rh ◽  
The Impact

14613 Background: Given the in-vitro evidence of potential increase in tumour radiosensitisation and hormonal deprivation-related tumour growth inhibiting effect by the addition of EGFR inhibitors, a randomised unblinded phase II trial was initiated to evaluate the impact of the addition of gefitinib to a combination of radiotherapy (RT) and maximal androgen blockage (MAB) in patients (pts) with high-risk localised prostate cancer. Methods: Eligible pts had biopsy proven localised prostate carcinoma Gleason score ≥7 and/or cT3 stage and/or initial PSA ≥ 20; without nodal and distant metastases. All pts were treated by 8 months MAB using LH-RH agonist (Zoladex 3.6 mg/month) and peripheral anti-androgen (Casodex 50 mg/day), and localised Conformal RT (Prostate + Seminal Vesicles, 75.6 Gy/42 daily fractions), initiated after 4 months of MAB. Pts were randomised to receive or not gefitinib 250 mg/day concomitantly for 8 months. The planned accrual was 98 pts. The end-points were ASTRO defined PSA-relapse-free survival at 18 months and toxicity. A safety evaluation was performed mid 2005. Results: 20 pts (10 per arm) were included from 10/2003 to 02/2005. No significant difference in RT or MAB-related toxicity was seen between the 2 arms. The addition of gefitinib significantly increased the frequency and intensity of reversible skin toxicity events (Rash-CTC grade 3–4: 4 pts Vs O pts, p = 0.04), with a trend for reversible transaminase enzymes elevation (TEE) (CTC grade 3–4: 2 pts Vs 0 pts). No treatment interruption was reported in the control arm. In the experimental arm, 3 pts completed treatment, 3 pts had a temporary (<10 days) gefitinib discontinuation (reversible asthenia and skin rash) and 4 pts had a permanent gefitinib discontinuation for reversible CTC grade 3 toxicity (skin rash: 2 pts, TEE: 2 pts). Conclusions: Gefitinib-related toxicity led to treatment discontinuation in 4 out of 10 patients. The trial is under review. This trial was supported by AstraZeneca. No significant financial relationships to disclose.

scholarly journals A phase II trial of neoadjuvant doxorubicin plus cyclophosphamide followed by lapatinib plus docetaxel sequential with adjuvant trastuzumab for treatment of early HER2 positive breast cancers

2017 ◽  
Vol 7 (2) ◽  
pp. 28
Author(s):  
Gregory A. Vidal ◽  
Namratha Vontela ◽  
Mary Chen ◽  
Julie M. Ryder ◽  
Struti Sheth ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Breast Conservation ◽  
Breast Cancers ◽  
Her2 Positive ◽  
Adjuvant Trastuzumab ◽  
Skin Reactions ◽  
Grade 3

Background: The use of HER2 targeting therapy has revolutionized the treatment of HER2 positive breast cancers. Here, we investigate whether a sequential approach to dual HER2 blockade of lapatinib followed by trastuzumab will result in improved clinical outcomes.Methods: This was a single institution, open label, single arm, phase II trial in women with HER2 positive breast cancer. Volunteers were treated with sequential neoadjuvant doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (AC) for 4 cycles followed by docetaxel (100 mg/m2) concurrent with lapatinib (1,250 mg) (TL) daily for 21 days for four cycles before definitive surgery. The primary end point was pathologic complete response (pCR).Results: The study accrued only 21 of the 71 planned patients from 2/28/2007 to 5/25/2010. All patients (100%) experienced down staging. The pCR rate was 41% (7/18). 11 patients had tumor size of T3 or greater, 3 of which experienced pCR and only 1 underwent breast conservation (lumpectomy). The most common hematologic AE (all grades) was anemia 17/21 (81%). There were no incidences of grade 3 or 4 anemia. 10 of 21 (48%) patients experience a non-hematologic grade 3 AE. The most common non-hematologic AEs (all grades) were irregular menses 20/21 (95%) and hand-foot-skin reactions 20/21 (95%). No increase cardiac abnormalities were noted. The DFS at data cut off was 87.5%.Conclusion: The provocative pCR and DFS results in this high risk locally advanced patient population should be viewed with caution given results of the Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation study (ALTTO) clinical trial.

The impact of cetuximab on the capecitabine plus oxaliplatin (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC): A randomized phase II trial of the Swiss Group for Clinical Cancer Research (SAKK)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3551-3551 ◽  
Author(s):  
M. Borner ◽  
W. Mingrone ◽  
D. Koeberle ◽  
R. Von Moos ◽  
D. Rauch ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
High Response ◽  
Line Treatment ◽  
First Line ◽  
Clinical Cancer Research ◽  
Grade 3 ◽  
The Impact ◽  
First Line Treatment

3551 Background: XELOX is a valuable alternative to continuous infusion FOLFOX type regimens in the treatment of MCC (Borner et al, JCO 2002, 1759). Cetuximab is an EGFR antibody, which has been shown to improve the efficacy of chemotherapy. A phase II study in first-line treatment of MCC has demonstrated a high response rate combining cetuximab with FOLFOX (Tabernero et al, Proc ASCO 2004, 3512). Methods: Multicenter, randomized two-arm phase II trial: OXA 130 mg/m2 day 1 and oral CAP 1000 mg/m2 bid days 1–14 every 21 days alone or in combination with cetuximab 250 mg/m2 weekly after a loading dose of 400 mg/m2. Treatment was limited to a maximum of 6 cycles. With 37 patients in each arm, the power was 90% to select the truly better arm if the true between-arm difference in response rate (RECIST) is at least 15%. The study was open for accrual until October 2005. Results: We present here the results of 74 patients included in the study. In 67 patients the first response data are available (investigators’ assessment after 3 cycles). The two arms are well balanced for relevant patient, disease and treatment characteristics. The study treatment was well tolerated with grade 3/4 toxicities in < 10% of the cycles in each arm. The frequency of side effects was balanced, but with more frequent skin toxicity in the cetuximab arm (6% versus 0% grade 3/4). Conclusions: Cetuximab seems to positively interact with XELOX in terms of efficacy but not toxicity. The cetuximab/XELOX combination appears to be a valuable option in first-line treatment of MCC especially if high response rates are a primary objective. This trial was supported in part by Merck KGaA and Sanofi-Aventis Switzerland. [Table: see text] No significant financial relationships to disclose.

Neoadjuvant IMC-A12 and combined androgen deprivation with prostatectomy for high-risk prostate cancer: A phase II trial.

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. TPS251-TPS251 ◽  
Author(s):  
J. P. Dean ◽  
S. R. Plymate ◽  
B. L. Dalkin ◽  
W. J. Ellis ◽  
D. W. Lin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Androgen Deprivation ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer

A phase II study of Recchia's immunomodulatory schedule (RIS) as a maintenance therapy in high-risk tumors after a response.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3074-3074
Author(s):  
Manuel Sureda ◽  
Joseba Rebollo ◽  
Begona Vazquez ◽  
Pere Bretcha ◽  
Rosa Cañon ◽  
...  
Keyword(s):  
High Risk ◽  
Solid Tumors ◽  
Phase Ii ◽  
Low Dose ◽  
Residual Disease ◽  
Phase Ii Study ◽  
Interleukin 2 ◽  
Induced Response ◽  
Response To Chemotherapy ◽  
Grade 3

3074 Background: F. Recchia et al. (Interleukin-2 and 13-cis retinoic acid in the treatment of minimal residual disease: A phase II study. Int J Oncol. 20: 1275-1282, 2002) previously defined the possibility of achieving a chronic immune stimulation through a prolonged low dose sc interleukin 2 (IL2)-based schedule, leading to a prolongation of PFS in advanced cancer patients (pts). A confirmatory phase II study was started. Methods: Pts diagnosed of high risk solid tumors in response to chemotherapy were included. RIS consisted in low dose IL2 (1.8 MU sc per day, 5 days per week, 3 weeks per month) plus oral isotreonin (CRA, 0.5 mg/kg) the same days of IL2 and/or sc PEG-interferon (50 µg per week of treatment). No Chx was allowed with RIS, but concurrent maintenance with TKI or Hx was permitted. Results: Since 08/2007 to 01/2013, 69 pts (39 M/30 F, median age 60 y, range 31-78) were included. 51 pts were treated with stage IV disease. 36 pts entered in complete response (CR), 29 in partial response (PR), 1 with progressive disease, 3 adjuvant. 4/69 grade 3/4 toxicity, (6%): 1 fatal poliserositis resistant to cortisone after 20 months of RIS, 1 stopped RIS for reaction requiring steroids, 1 for multiinfarction dementia, 1 for grade 3 liver toxicity. 3 pts presented other alterations managed along the course of the RIS (1 PVT, 1 ITP, 1 angina resolved after stent placement). Grade 1-2 fever, fatigue and joint pain were commonly observed but usually controlled with NSAIDs. Among the 68 pts evaluable for response, one pt progressed, 26 presented stable disease (median TTP 3 mo, range 2-28), 3 presented PR (1 melanoma, 1 prostatic ca, 1 ovarian ca; 9, 11 and 28 mo respectively), and 38 maintained or presented CR (median TTP 19 mo, range 2-62+). Three pts in PR were converted to a CR during RIS (1 pancreatic ca, 1 ovarian ca, 1 larynx ca). Conclusions: In this study we confirm the previous results reported by F. Recchia et al. RIS represents a good alternative for high risk pts with solid tumors after systemic chemotherapy induced response with acceptable tolerability and offers in selected pts a possibility of obtaining a CR after a PR. Further validation and randomized studies are warranted.

Bendamustine in Combination with Rituximab (BR) for Patients with Relapsed Chronic Lymphocytic Leukemia (CLL): A Multicentre Phase II Trial of the German CLL Study Group (GCLLSG).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3106-3106 ◽  
Author(s):  
Kirsten Fischer ◽  
Stephan Stilgenbauer ◽  
Carmen D. Schweighofer ◽  
Jasmin Renschler ◽  
Raymonde Busch ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Residual Disease ◽  
Ex Vivo ◽  
Lymphocytic Leukemia ◽  
Fish Analysis ◽  
Entire Study ◽  
Mutational Status ◽  
Grade 3

Abstract Introduction: Bendamustine has shown considerable activity in monotherapy for solid and lymphoid malignancies including CLL and has been used for more than 30 years in anti-cancer treatment. In vitro and ex vivo studies have demonstrated synergistic pro-apoptotic effects of bendamustine and the CD20 antibody rituximab (BR) in primary B-CLL cells. Encouraging clinical results have been obtained using BR combination treatment in relapsed/refractory NHL or mantle cell lymphoma. The present phase II trial represents the first study assessing efficacy and toxicity of bendamustine in combination with rituximab in pts with relapsed/refractory B-CLL. Patients and Methods: Between March 2006 and June 2007 81 pts with relapsed/refractory B-CLL and a median number of 2 pretreatments were enrolled into this trial. Bendamustine was given at a dose of 70 mg/m2 on day 1 and 2, combined with 375mg/m2 rituximab for the first cycle and 500 mg/m2 for the second and subsequent cycles. BR treatment was administered every 28 days up to 6 courses. Blood samples were taken for molecular cytogenetics by fluorescence in situ hybridization (FISH), analysis of the IgVH mutational status and expression of ZAP70/CD38. Assessment of minimal residual disease (MRD) was evaluated in peripheral blood and bone marrow by 4-colour flow cytometry. Results: So far data of 31 pts (median age 66 years) with a total of 126 treatment cycles are available for analysis. There was notable toxicity with 48 reported CTC grade 3/4 adverse events, particularly myelosuppression and infections: grade 3/4 anemia occurred in 6.3.%, leukopenia/neutropenia in 10.8% and thrombocytopenia in 11.9% of all courses. 6 episodes of CTC grade 3/4 infections were documented: 1 sinusitis maxillaris, 1 FUO and 1 abscess, all of them being reversible after antibiotics. However, 3 pts died due to severe infections including 2 fatal pneumonias and 1 urosepsis. One pt died due to myocardial infarction. Regarding efficacy, 23 pts were evaluable for response: The overall response rate (ORR) was 65.2% with a CR rate of 13.0% (3 pts) and a PR rate of 52.2% (12 pts). No molecular remission was observed by 4-colour cytometry. Stable disease (SD) was achieved in 26.1% (6 pts) whereas 2 pts had progressive CLL (PD, 8.7%). Responses were observed in the majority of pts with genomic aberrations 11q deletion (ORR: 4/5) and trisomy 12 (ORR: 2/3), while none of the pts with 17p deletion (ORR: 0/4) was responsive (P=0.006). Conclusion: Bendamustine plus rituximab is an effective regimen in refractory/relapsed B-CLL. Major treatment toxicities were myelosuppression and infections. Updated data with respect to toxicity and efficacy based on the entire study population will be available for the Meeting.

Phase II Trial of Initial Safety and Toxicity Prior to the Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma (E3A06): A Trial Coordinated by the Eastern Cooperative Oncology Group

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4079-4079 ◽  
Author(s):  
Sagar Lonial ◽  
Susanna Jacobus ◽  
Matthias Weiss ◽  
Rafael Fonseca ◽  
Madhav V. Dhodapkar ◽  
...  
Keyword(s):  
High Risk ◽  
Phase Ii ◽  
Research Funding ◽  
Plasma Cells ◽  
Phase Ii Trial ◽  
Phase Iii ◽  
Hematologic Toxicity ◽  
Trial Testing ◽  
Grade 3 ◽  
Smoldering Myeloma

Abstract Abstract 4079 The treatment and natural history of asymptomatic or smoldering myeloma has been an area of intense preclinical and clinical study. Historical attempts to treat these patients have not demonstrated significant benefit, likely as a consequence of limited therapeutic options as well lack of attention to the vast heterogeneity contained within the diagnosis of smoldering myeloma. More recent risk criteria from both US and Spanish investigators have identified a cohort of smoldering myeloma patients at high risk for progression to myeloma in a short time. Recently the PETHEMA group has conducted a randomized clinical trial testing lenalidomide and dexamethasone vs observation among high risk smoldering patients and has demonstrated a clear benefit in terms of progression free survival and hints towards improvement in overall survival favoring early intervention. To further evaluate the potential benefit of early intervention in a high risk smoldering cohort, the ECOG myeloma group designed a phase II trial testing the safety and efficacy of single agent lenalidomide with the intent of broadening to a randomized phase III trial if toxicity was acceptable. We report here on the safety portion of the phase II trial. The phase II group of patients received lenalidomide at a dose of 25 mg days 1–21 every 28 days to evaluate the early toxicity and tolerance of this dosing. The dose of lenalidomide could be adjusted based on toxicity using a defined dose-modification guideline in the protocol. The primary endpoint for the safety study was the rate of any treatment-related grade 4–5 non-hematologic toxicity plus grade 3 non-hematologic toxicity that affects vital organ function (such as cardiac, hepatic, or thromboembolic events) observed within 6 cycles of treatment. The goal was to enroll 34 patients; if 9 or more patients experience toxicity as defined, then the study would not continue. In terms of eligibility, patients were to be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months, as confirmed by both of the following: bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells and an abnormal serum free light chain ratio (<0.125 or >8.0) by serum FLC assay. Further, patients must have measurable levels of monoclonal protein (M-protein): >=1g/dL on serum protein electrophoresis or >=200 mg of monoclonal protein on a 24 hour urine protein electrophoresis. Patients must have no lytic lesions on skeletal surveys and no hypercalcemia. Among the 36 patients enrolled in the phase II study, 56% were female, and 44% were 65 years and older. Treatment and toxicity data at a minimum through cycle 6 is complete as of August 2, 2102. The last patient enrolled completed cycle 6 treatment on June 7, 2012. The median treatment duration of the entire cohort is 9 cycles (range 1–18 cycles), with 86% of patients completing at least 6 cycles of treatment. Ten patients are off treatment for the following reasons: disease progression (n=1), AE/complication (n=5), death (n=1) and patient withdrawal/refusal (n=3); 5 of the 10 patients ended treatment before completing 6 cycles. Of 36 patients assessed for toxicity, 8 patients [22.2%, 90% CI: (11.6%-36.5%)] experienced worst grade treatment-related non-hematologic toxicity of grade 3 or higher. Separately, 6 patients experienced unrelated non-hematologic toxicity of grade 3 or higher. Three patients [8.3%, 90% CI: (2.3%-20.2%)] experienced a serious adverse event as defined for the purposes of the phase II toxicity analysis (treatment-related grade 4–5 non-hematologic toxicity or grade 3 non-hematologic toxicity that affects vital organ function (such as cardiac, hepatic, or thromboembolic events). Based upon this analysis of the study, the phase II portion of the trial met the prespecified safety benchmark established to allow for phase III expansion, and accrual to the phase III portion of this study will begin. Efficacy data will be presented at the time of presentation. Disclosures: Lonial: Novartis: Consultancy; Millennium: Consultancy; Onyx: Consultancy; BMS: Consultancy; Celgene Corp: Consultancy; Merck: Consultancy. Off Label Use: Lenalidomide is not approved for treatment of smoldering MM. Fonseca:Medtronic: Consultancy; Otsuka: Consultancy; Celgene: Consultancy; Genzyme: Consultancy; BMS: Consultancy; Lilly: Consultancy; Onyx: Consultancy; Binding site: Consultancy; Millenium: Consultancy; AMGEN: Consultancy; Celgene : Research Funding; Onyx: Research Funding; prognostication of MM based on genetic categorization of the disease: Prognostication of MM based on genetic categorization of the disease, Prognostication of MM based on genetic categorization of the disease Patents & Royalties. Dhodapkar:Celgene: Research Funding; KHK: Research Funding.

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