Phase II Trial of Single Agent Bortezomib (VELCADE®) in Patients with Previously Untreated Multiple Myeloma (MM).

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 336-336 ◽  
Author(s):  
Paul G. Richardson ◽  
Asher Chanan-Khan ◽  
Robert L. Schlossman ◽  
Nikhil C. Munshi ◽  
Patrick Wen ◽  
...  
Keyword(s):  
Single Agent ◽  
Standard Of Care ◽  
Symptomatic Treatment ◽  
Response To Treatment ◽  
High Dose ◽  
Dose Modification ◽  
Phase 2 Study ◽  
Gi Symptoms ◽  
Before And After ◽  
Skin Biopsies

Abstract Introduction: Bortezomib, a first in class proteasome inhibitor, has become a standard of care in the treatment of relapsed and refractory MM. A recent randomized Phase 3 trial showed an improvement in time to progression (TTP) and overall survival relative to dexamethasone (dex) in patients with relapsed MM and 1–3 prior lines of therapy. In relapsed MM, the rate of treatment -emergent significant peripheral neuropathy (PN) with bortezomib was higher in patients with baseline neuropathy. The incidence and severity of PN in front-line treatment will be important to define. This multi-center, Phase 2 study was planned to evaluate the activity and toxicity (in particular PN) of single agent bortezomib in previously untreated pts. Methods: Response rate, TTP, tolerability, incidence and severity of PN, and the effect of dose modification, symptomatic treatment and nutritional supplements on PN were evaluated in previously untreated, symptomatic MM pts. Pts received bortezomib 1.3 mg/m2 on D 1, 4, 8, and 11 of a 21-d cycle and response to treatment was assessed every 2 cycles. Dex was not permitted. Neurologic evaluation was required before and after treatment, and if significant PN developed during therapy. Results: 28 pts with symptomatic MM have been treated with a median age of 60 yrs, IgG isotype in 68% and Stage III disease in 52%. Analysis of best paraprotein response after ≥ 2 cycles revealed CR in 1 (5%) pt and PR in 8 (36%), for an ORR of 41% in 22 evaluable pts. An additional 5 pts (23%) achieved MR, with stable disease in 6 pts (27%); 2 pts progressed (9%). The most commonly reported adverse events included PN, fatigue, GI symptoms and rash. Neurological evaluation has been performed in all pts, including nerve conduction studies (NCS), assessment of autonomic function and skin biopsy for EM imaging of small fibers in a subset (n=19). Six of 28 pts (21%) so far have developed PN with most being G2: 1 pt experienced G3 PN and drug was discontinued. Dose modification was required in 4 pts and supplements have been used in all pts with PN. Preliminary results of neurological testing and NCS have indicated subclinical PN at baseline prior to therapy in 6/19 (30%) of pts evaluated by NCS, with small fiber, axonal PN documented in 1 pt with treatment-emergent PN. Bortezomib-related toxicity has otherwise been manageable. Conclusion: Single agent bortezomib is a promising approach for newly diagnosed pts and is without the complications of high-dose dex. The incidence of subclinical PN by NCS at baseline prior to therapy is currently 30%; G2 or greater treatment-emergent PN has occurred in 21% of pts and was G3 in only 1 pt (4%) to date. Further assessment of PN including analysis of skin biopsies is ongoing.

scholarly journals Evaluation of Histopathological Changes in Control Biopsies Which Taken 48 Sessions after NBUVB Phototherapy for Early-Stage Mycosis Fungoides

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Ebru Zemheri ◽  
Seyma Ozkanli ◽  
Ilkin Zindanci ◽  
Serkan Senol ◽  
Ozge Akbulak ◽  
...  
Keyword(s):  
Stratum Corneum ◽  
Early Stage ◽  
Response To Treatment ◽  
Epidermal Thickness ◽  
Dermal Fibrosis ◽  
Narrowband Uvb ◽  
Before And After ◽  
Histomorphological Changes ◽  
Skin Biopsies ◽  
Perivascular Infiltration

Background.There are not many studies investigating histomorphological changes in 48 sessions in patients with early-stage MF after narrowband UVB (NBUVB) treatment. Our purpose is to evaluate histological features of phototherapy after 48 sessions and determine which parameters are more reliable for controlling skin biopsies.Methods.Biopsies of 32 patients with early stage of MF, who were treated with NBUVB phototherapy, were histologically evaluated before and after the treatments, including epidermotropism, stratum corneum, epidermal thickness, dermal infiltration, papillary dermal fibrosis, vascular alterations, and other dermal changes. We discuss the histomorphological effects of NBUVB phototherapy on skin biopsies by comparing the responders with nonresponders, with before and after the treatment.Results.9 patients (28%) did not give any response to treatment. Alleviation in epidermotropism, increases in parakeratosis and normal keratosis, perivascular infiltration, and melanophages, decrease in the lichenoid/patchy lichenoid infiltration pattern after the treatment was statistically significant. Comparing by response, normalization of stratum corneum and epidermis, orthohyperkeratosis, decrease in linearly arranged cells, the lichenoid/patchy lichenoid infiltration, the loss of inflammation were statistically significant in responders group.Conclusion.We detected a significant decrease in linearly arranged cells after phototherapy, indicating that it is an “important diagnostic parameter" in evaluation of therapeutic response.

Concurrent chemotherapy practice patterns for head and neck cancer: What is standard of care?

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5542-5542
Author(s):  
S. J. Wong ◽  
Z. Agha ◽  
S. Milligan
Keyword(s):  
Head And Neck ◽  
Initial Dose ◽  
Low Dose ◽  
Single Agent ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Prescribing Patterns ◽  
Phase Iii ◽  
High Dose ◽  
Community Based

5542 Background: The superiority of concurrent high dose cisplatin and radiation (RT) compared to RT alone for pts with locally advanced squamous cell cancer of the head and neck (SCCHN) has been demonstrated in large prospective phase III clinical trials. However, little is known regarding general prescribing patterns for chemotherapy (CT) utilization in combined modality treatment (CMT) for SCCHN. We conducted the present study to gain insight as to whether results from pivotal phase III trials affect utilization of concurrent CT in academic and community centers. Methods: We analyzed individual data from 326 SCCHN pts treated with concurrent CT and RT between 03/2003 and 12/2004 from 53 centers (43 community-based, 7 academic, and 3 VA or military) using electronically captured data from IntelliDose, a chemotherapy order software program. Results: Of 326 total pts, 123 pts (38%) received single agent cisplatin. From this group, 71 (58%) received low dose cisplatin (<74 mg/m2, mean initial dose 67 mg), while 52 patients (42%) received high dose cisplatin (≥ 74 mg/m2, mean initial dose 189 mg). 72 pts (22%) received carboplatin/paclitaxel, 60 pts (18%) received cisplatin /5FU, 18 pts (5.5%) received single agent carboplatin, while 6 pts (1.8%) received cetuximab either alone or in combination with cisplatin. Other infrequently used regimens (each < 5%) cumulatively accounted for 14% of pts treated. Comparison of chemotherapy utilization between academic and community-based practice centers showed no statistical difference with respect to use of high dose cisplatin versus low dose cisplatin, or single agent cisplatin versus non-cisplatin regimens. Conclusions: Despite evidence from phase III studies that concurrent high dose cisplatin is the standard of care for CMT of locally advanced SCCHN, utilization of other regimens, such as weekly low dose cisplatin, are commonly utilized. [Table: see text]

Bortezomib, lenalidomide, and dexamethasone (VRD) is superior to lenalidomide, adriamycin, and dexamethasone (RAD) prior to risk-adapted transplant in newly diagnosed myeloma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 8521-8521
Author(s):  
Stefan Knop ◽  
Christian Langer ◽  
Monika Martha Engelhardt ◽  
Florian Bassermann ◽  
Martin Schreder ◽  
...  
Keyword(s):  
Study Drug ◽  
Standard Of Care ◽  
High Dose Chemotherapy ◽  
Autologous Stem Cell Transplant ◽  
High Dose ◽  
Cell Transplant ◽  
Newly Diagnosed ◽  
Phase 2 Study ◽  
Set Up ◽  
The Cost

8521 Background: High-dose chemotherapy (HDT) followed by autologous stem cell transplant (SCT) remains a standard of care in patients (pts) with newly diagnosed (ND) multiple myeloma (MM). While lenalidomide (R) maintenance is acknowledged to improve outcomes, intensified consolidation (such as tandem-SCT) has yielded conflicting results. Allogeneic (allo) SCT holds the promise of curative potential at the cost of higher treatment-related mortality (TRM). In a previous phase 2 study, we showed a very low TRM rate (6.1%) and feasibility of 12 months (mos) of R maintenance (maint), with auto/allo SCT after R/adriamycin/dexamethasone (RAD). This prompted us to compare, on a randomized rather than a “biological assignment” basis, a second auto- versus (vs) an allo-SCT in pts with an unfavorable prognosis. Methods: The current protocol (DSMM XIV, NCT01685814) was set up according to a double 2x2-factorial design. Post-induction (PInd) CR rate was the efficacy endpoint for the comparison of RAD vs bortezomib (V)/RD (VRD; 3 cycles each). If pts had achieved >VGPR to HDT, a second randomization (2ndR) compared immediate R maint (arm A2) with a second auto-SCT (B2). In case of < VGPR, pts were randomized between a second auto- (C2) and allo-SCT (D2). Planned R maint. duration was 36 mos, except after allo (12 mos). Results: Between 05/2012-06/2016, 476 pts were randomized and 469 received at least one dose of study drug. Pts’ median age was 55 (range, 32–65) years. 11.3% of pts had FISH del17p; 11.6% had t(4;14); and 4.4% had t(14;16). PInd CR rate was 11.8% (90% CI, 7.9%-16.3%) with RAD and 13.0% (90% CI, 8.9-18.0) with VRD (P = .697). 382 pts underwent R2 with 279 pts. (73%) in >VGPR and 103 (27%) in < VGPR, respectively. Median duration of R maint (N = 298) was 21.2 mos for A2, 23.1 mos for B2, 27.4 mos for C2, and 11.0 mos. for D2. At a median follow-up of 40.2 (0.5-87.0) months, median PFS from first randomization with RAD was 41.7 (95% CI, 35.4-48.5) mos vs. 53.7 (95% CI, 46.2-63.1) mos with VRD (P = .0439). Median PFS from 2ndR was 38.7 (95% CI, 30.3-47.3) mos for the 181 RAD vs. 50.7 (95% CI, 44.4-64.9) mos for the 201 VRD pts (P = .0126). Median overall survival (OS) cannot be estimated. With 47 deceased RAD vs 36 VRD pts, HR was .671 (95% CI, .435-1.037; P = .0703). Conclusions: In this study, median PFS benefit was 12 mos in favor of VRD vs. RAD despite comparable PInd CR. We show for the first time a len-PI to be superior to a len-chemo triplet, confirmed with positive OS trends. 3-year PFS for all consolidation arms will be presented. Clinical trial information: NCT01685814 .

scholarly journals Comparison of Laughter Yoga and Anti-Anxiety Medication on Anxiety and Gastrointestinal Symptoms of Patients with Irritable Bowel Syndrome

2019 ◽  
Vol 11 (4) ◽  
pp. 211-217 ◽  
Author(s):  
Tahmine Tavakoli ◽  
Navid Davoodi ◽  
Toktam Sadat Jafar Tabatabaee ◽  
Zeinab Rostami ◽  
Homa Mollaei ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Gastrointestinal Symptoms ◽  
Symptomatic Treatment ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Yoga Group ◽  
Gi Symptoms ◽  
Before And After ◽  
The Difference ◽  
Irritable Bowel

BACKGROUND Irritable bowel syndrome (IBS) is the most common chronic gastrointestinal (GI) disorder. Patients with IBS usually suffer from anxiety and depression. A combination of psychological approaches and pharmacological treatments can be a significantly effective treatment for IBS. The main objective of the present study was to provide a therapeutic plan based on laughter yoga and anti-anxiety medication, employed for the very first time, and to determine the effectiveness of these treatments on the anxiety and GI symptoms of patients with IBS. METHODS In this randomized, controlled, clinical trial, the participants were 60 patients selected from those who referred to the GI clinic of Vali-asr Hospital (Birjand, Iran) during the study period (April 2017 to March 2017) and were diagnosed as having IBS based on ROME III criteria. The participants were randomly assigned to either the laughter yoga group, the anti-anxiety medication group, or the symptomatic treatment (control) group. Severity levels of anxiety and GI symptoms before and after intervention were determined and compared among these three groups according to approved protocols. RESULTS The severity of IBS symptoms after the interventions was more greatly reduced in the laughter yoga group than in the anti-anxiety medication and control groups (p = 0.006). The severity of anxiety after interventions decreased in all three groups, especially in the yoga treatment group, but the difference was not statistically significant (p = 0.1). CONCLUSION Laughter yoga is more effective than anti-anxiety medication in reducing the GI symptoms of patients with IBS. Therefore, applying laughter yoga along with common pharmacological therapies for patients with IBS might be strongly advised.

Current Trends in Autologous Stem-Cell Transplantation for Myeloma in the Era of Novel Therapies

2011 ◽  
Vol 29 (14) ◽  
pp. 1898-1906 ◽  
Author(s):  
Philippe Moreau ◽  
Hervé Avet-Loiseau ◽  
Jean-Luc Harousseau ◽  
Michel Attal
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Standard Of Care ◽  
High Dose ◽  
Novel Therapies ◽  
Current Trends ◽  
Before And After

Since the mid 1990s, high-dose therapy followed by autologous stem-cell transplantation (ASCT) has been considered the standard of care for frontline therapy in younger patients with multiple myeloma (MM). During the past 10 years, thalidomide, bortezomib, and lenalidomide have been widely incorporated to the therapeutic armamentarium for the treatment of this disease. These agents show promise for improving the rate of complete remission both before and after ASCT without increasing toxicity. However, it is not clear whether such therapies are superior if they are used as an alternative to transplantation or whether they may reduce the need for and use of transplantation in patients in whom treatment is indicated. Therefore, the role of ASCT itself is a matter of debate: Should it be used upfront or as salvage treatment at the time of progression in patients initially treated with novel agents? This review presents current trends in ASCT for MM in the era of novel therapies.

scholarly journals The Management of Classical Hodgkin's Lymphoma: Past, Present, and Future

2011 ◽  
Vol 2011 ◽  
pp. 1-17 ◽  
Author(s):  
S. E. Richardson ◽  
C. McNamara
Keyword(s):  
Hodgkin’S Lymphoma ◽  
Single Agent ◽  
Late Toxicity ◽  
Standard Of Care ◽  
High Dose Chemotherapy ◽  
Hodgkin's Lymphoma ◽  
Haematopoietic Stem Cell ◽  
High Dose ◽  
Current Standard ◽  
Number Of Patients

The management of classical Hodgkin's lymphoma (CHL) is a success story of modern multi-agent haemato-oncology. Prior to the middle of the twentieth century CHL was fatal in the majority of cases. Introduction of single agent radiotherapy (RT) demonstrated for the first time that these patients could be cured. Developments in chemotherapy including the mechlorethamine, vincristine, procarbazine and prednisolone (MOPP) and Adriamycin, bleomycin, vinblastine and dacarbazine (ABVD) regimens have resulted in cure rates of over 80%. Even in relapse, CHL patients can be salvaged with high dose chemotherapy and autologous haematopoietic stem cell transplantation (ASCT). Challenges remain, however, in finding new strategies to manage the small number of patients who continue to relapse or progress. In addition, the young age of many Hodgkin's patients forces difficult decisions in balancing the benefit of early disease control against the survival disadvantage of late toxicity. In this article we aim to summarise past trials, define the current standard of care and appraise future developments in the management of CHL.

scholarly journals Pracinostat plus azacitidine in older patients with newly diagnosed acute myeloid leukemia: results of a phase 2 study

2019 ◽  
Vol 3 (4) ◽  
pp. 508-518 ◽  
Author(s):  
Guillermo Garcia-Manero ◽  
Yasmin Abaza ◽  
Koichi Takahashi ◽  
Bruno C. Medeiros ◽  
Martha Arellano ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Intensive Therapy ◽  
Single Agent ◽  
Response To Treatment ◽  
Phase 2 ◽  
Newly Diagnosed ◽  
Phase 2 Study ◽  
Acute Myeloid

Abstract Pracinostat, a potent oral pan-histone deacetylase inhibitor with modest single-agent activity in acute myeloid leukemia (AML), has shown synergistic antitumor activity when combined with azacitidine. This single-group, multicenter phase 2 study assessed the safety and efficacy of pracinostat combined with azacitidine in patients who were at least 65 years old with newly diagnosed AML and who were ineligible for standard induction chemotherapy. Patients received pracinostat 60 mg/d, 3 d/wk, for 3 consecutive weeks, plus azacitidine 75 mg/m2 daily for 7 days in a 28-day cycle. Primary endpoints were complete remission (CR), CR with incomplete count recovery (CRi), and morphologic leukemia-free state (MLFS) rates of the combination. Secondary endpoints included safety, progression-free survival (PFS), and overall survival (OS) of the regimen. Fifty patients (33 de novo, 12 secondary, and 5 therapy-related AML) were enrolled. Twenty-six patients (52%) achieved the primary endpoint of CR (42%), CRi (4%), and MLFS (6%). Median OS and PFS were 19.1 months (95% confidence interval [CI], 10-26.5 months) and 12.6 months (95% CI, 10-17.7 months), respectively, with a 1-year OS rate of 62%. Forty-three patients (86%) experienced at least 1 grade 3 or worse treatment-emergent adverse event with the combination, with infections (52%), thrombocytopenia (46%), and febrile neutropenia (44%) reported as the most common toxicities. The 30- and 60-day all-cause mortality rates were 2% and 10%, respectively. DNA sequencing revealed somatic mutations at baseline, and clearance rates correlated with response to treatment. Pracinostat plus azacitidine is a well-tolerated and active regimen in the frontline treatment of older patients with AML unfit for intensive therapy. A larger controlled trial is ongoing. This trial was registered at www.clinicaltrials.gov as #NCT01912274.

Practice-Changing Developments in Stage III Melanoma: Surgery, Adjuvant Targeted Therapy, and Immunotherapy

2018 ◽  
pp. 759-762 ◽  
Author(s):  
Ragini R. Kudchadkar ◽  
Olivier Michielin ◽  
Alexander C. J. van Akkooi
Keyword(s):  
Controlled Trial ◽  
Single Agent ◽  
Standard Of Care ◽  
Stage Iii ◽  
High Dose ◽  
Randomized Controlled ◽  
Braf Inhibition ◽  
Selective Lymphadenectomy ◽  
Stage Iii Melanoma ◽  
Resected Stage

In this article, we will focus on the practice-changing developments for stage III melanoma, from the use of the sentinel node (SN) biopsy to complete lymph node dissection (CLND) and upcoming adjuvant therapies. MSLT-1 (Multicenter Selective Lymphadenectomy Trial-1) was the first and only prospective randomized controlled trial to examine whether the SN biopsy has any notable melanoma-specific survival benefit (primary endpoint). MSLT-1 randomly assigned 2,001 patients to undergo either wide local excision (WLE) and an SN biopsy or WLE and nodal observation. Two prospective randomized controlled trials have examined the potential benefit for immediate CLND versus delayed CLND after sequential observation. Both the DECOG-SLT and MSLT-2 trials failed to demonstrate a notable benefit for immediate CLND; therefore, sequential follow-up with ultrasonography and a delayed CLND in the case of relapse should be considered the new standard of care. The CheckMate 238 study demonstrated a notable benefit for adjuvant nivolumab in terms of 18-month relapse-free survival (RFS) rates compared with high-dose adjuvant ipilimumab. Single-agent adjuvant BRAF inhibition has been examined and failed to improve RFS. However, the COMBI-AD study did demonstrate a substantial benefit for combination BRAF and MEK inhibition for patients with BRAF-mutated resected stage IIIA to IIIC melanoma.

scholarly journals Management of Gastroenteritis in Primary Care – A Review

2021 ◽  
pp. 224-231
Author(s):  
Najlaa Mohammad Alsudairy ◽  
Saad Rashed S Aljameely ◽  
Fatimah Mohammed J. Alsaihati ◽  
Ahmed Mamdouh A. Alkhawfi ◽  
Mansour Hajed M Alharthi ◽  
...  
Keyword(s):  
Primary Care ◽  
Primary Care Physicians ◽  
High Standard ◽  
Cost Effective ◽  
Standard Of Care ◽  
Symptomatic Treatment ◽  
Effective Control ◽  
Oral Rehydration ◽  
Rehydration Solutions ◽  
Gi Symptoms

Gastroenteritis is one the most common diseases worldwide, and it’s more dangerous in children, although in most time it’s self-limited, it can be fatal in case of children, the most dangerous side of GE is diarrhea and the dehydration that follows it. Since dehydration is the most dangerous symptom of the Gastroenteritis Oral rehydration solutions and even intravenous solution intake (in case of severe dehydration) is the main treatment, followed by symptomatic treatment such anti-emetics or antidiarrheal drugs, although caution should be considered for drugs used in children. The need to make cost-effective diagnostic and treatment decisions, avoid unnecessary investigation and referral, provide long-term effective control of symptoms, and minimize the risk of complications constitute the main challenges that PCPs face. During the last few years, the role of primary care physicians in the diagnosis and management of gastroenteritis has been recognized as very important, and it has been suggested that they have all the available resources in order to ensure high standard of care for their patients. In particular, clearly articulated clinical practice guidelines, effective medications, accurate noninvasive investigations, and evidence-based primary care management plans are available to support PCPs who want to raise their threshold for referring patients with GI symptoms.

Campath-1H May Have Activity in the Treatment of Multiple Myeloma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4931-4931 ◽  
Author(s):  
Cristina Gasparetto ◽  
Mitchell E. Horwitz ◽  
Jon P. Gockerman ◽  
Carlos M. de Castro ◽  
Joseph O. Moore ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Renal Insufficiency ◽  
Opportunistic Infections ◽  
Standard Dose ◽  
Single Agent ◽  
Treatment Protocol ◽  
Response To Treatment ◽  
High Dose ◽  
Pharmacokinetic Studies ◽  
Cell Transplant

Abstract Previously we have demonstrated that multiple myeloma cell lines and primary cells express CD52, the antigenic target of Campath-1H, and that they undergo apoptosis following treatment with alemtuzumab in-vitro (Gasparetto et al. ASH #3210,2002). Based on these observations, we initiated a clinical trial where patients with advanced, multiply relapsed MM were treated with subcutaneous (sc) alemtuzumab as a single agent. Nine patients (6 men/4 women, age range 45–69 yrs) were initially treated with the standard dose of 30mg sc three times per week for up to 12 weeks. All patients had at least 4 lines of prior therapy and 8/9 patients had undergone high dose chemotherapy followed by autologous peripheral blood stem cell transplant. Treatment related toxicities included pancytopenia in all patients with grade IV neutropenia in the first four patients, necessitating withdrawal from study. Subsequently, all patients were treated with G-CSF and aggressive transfusion support and no further patients were removed from study due to cytopenias. All patients were prophylaxed with Famvir, Fluconazole and Septra and no opportunistic infections were noted during treatment. Two patients developed acute renal insufficiency that reversed when alemtuzumab was discontinued. One patient completed the entire 12 weeks of treatment. One patient had a PR with a 40% reduction in M-protein after two months of treatment, which reversed once Campath-1H was discontinued. Pharmacokinetic studies of one patient demonstrated that it required 8–10 weeks of treatment using the sc protocol to achieve serum levels of alemtuzumab of 1ug/ml, the level considered to be tumoricidal in-vivo. Based on this observation, the treatment protocol was modified so that the initial week of escalating doses was given IV to achieve more rapid therapeutic levels. Following this, sc alemtuzumab was given as above. One patient with non-secretory multiple myeloma with relapsed disease following 5 prior lines of therapy has been treated with this modified protocol. Treatment with alemtuzumab and growth factor support in this patient has been well tolerated except for the development of RSV pneumonia. At 4 weeks, a PET scan demonstrated a significant overall decrease in metabolic activity in multiple bony areas consistent with a response to treatment. These initial results suggests that alemtuzumab is associated with significant toxicities in patients with advanced multiple myeloma including pancytopenia, infections and possibly renal insufficiency but all of these were reversible and have been minimized with aggressive prophylactic therapy. Alemtuzumab does appear to have modest activity against MM in this heavily pre-treated group suggesting that it should be explored in combination with other agents and at earlier stages of disease.

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