scholarly journals Increased Prevalence of Fragmented QRS in Randomly Selected Group of Multiple Myeloma Patients: A Pilot Study to Assess Prevalence

Cureus ◽  
2021 ◽  
Author(s):  
Angel López-Candales ◽  
Fuad Habash ◽  
Srikanth Vallurupalli
Keyword(s):  
Multiple Myeloma ◽  
Pilot Study ◽  
Fragmented Qrs

A family-centered intervention for the transition to living with multiple myeloma as a chronic illness: A pilot study

2017 ◽  
Vol 35 ◽  
pp. 86-89 ◽  
Author(s):  
Susan R. Mazanec ◽  
Sarah Miano ◽  
Linda Baer ◽  
Erica L. Campagnaro ◽  
Abdus Sattar ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Chronic Illness ◽  
Pilot Study ◽  
Family Centered

High Dose Simvastatin Has No Beneficial Effect on Markers of Bone Turn-Over in Multiple Myeloma.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4824-4824
Author(s):  
Teis E. Sondergaard ◽  
Per T. Pedersen ◽  
Thomas L. Andersen ◽  
Thomas Lund ◽  
Patrick Garnero ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Pilot Study ◽  
Bone Resorption ◽  
Bone Formation ◽  
High Dose ◽  
Osteoclast Activity ◽  
Bone Formation Markers ◽  
Bone Degradation ◽  
Activity Trap

Abstract Background: Bone degradation in multiple myeloma (MM) is a result of increased bone degradation by osteoclasts that is not compensated for by bone forming osteoblasts. Ideally new drugs used for treatment of MM should target not only the myeloma cells but also the imbalance between bone resorption and bone formation. Statins have been shown to inhibit myeloma cell proliferation and induce apoptosis in vitro. Furthermore statins have been shown to stimulate osteoblasts and inhibit osteoclasts both in vitro and in animal models. Statins are normally used at doses around 20–80 mg/day, but in order to reach serum concentrations that can match the in vitro experiments MM patients were treated with 15 mg/kg/day of Simvastatin (HD-Sim) divided in two daily doses in this study. This high dose has previously been found to be safe for MM patients (Haematologica 2006, 91,542–545) Patients and methods: Six patients with advanced MM have been included in this pilot study, 4 males and 2 females with an average age of 68 years and an average duration of disease of 43 months. The patients were treated with 2 cycles of HD-Sim for seven days followed by a break of 21 days in a 4-weeks cycle. Two of the patients were treated with bisphosphonates during the study, and 4 had previously been treated with bisphosphonates. Endpoints are change in concentrations of markers of osteoclast activity (TRAP) or bone resorption (CTX, NTX, ICTP) or markers of bone formation (Osteocalcin and PINP). Cholesterol, OPG and DDK-1 were also measured. Results: Two patients completed the protocol with two cycles of HD-Sim at full dose, 2 patients were reduced to 7.5 mg/kg/day simvastatin in cycle 2 due to nausea and diarrhea and 2 patients left the protocol after 3 weeks (deaths not related to high dose simvastatin). All patients experienced gastrointestinal toxicity grade 1–2. Myalgia and other muscular symptoms grade 1–2 were reported by 5 patients but were not associated with an increase in creatin kinase. TRAP and NTX activity in serum increased for all 6 patients during the seven days of treatment with HD-Sim indicating that bone resorption may have been stimulated rather than inhibited. The other markers of bone resorption and the bone formation markers showed no change. All patients responded with a significantly reduced level of cholesterol in serum. None of the patients showed any reduction in free monoclonal light chains or monoclonal proteins in serum during treatment with HD-Sim and 2 of the 4 patients completing the protocol showed progression of diseases. Conclusion: This pilot study of HD-Sim in advanced MM has been terminated due to lack of response and evidence from two markers of osteoclast activity (TRAP) and bone resorption (NTX) that HD-Sim may be harmful rather than beneficial in MM.

Clinical and Correlative Pilot Study Of Carfilzomib, Lenalidomide, and Dexamethasone Followed By Lenalidomide Extended Dosing (CRd – R) In High Risk Smoldering Multiple Myeloma Patients

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1939-1939 ◽  
Author(s):  
Ola Landgren ◽  
Sham Mailankody ◽  
Mary Kwok ◽  
Elisabet E. Manasanch ◽  
Manisha Bhutani ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Flow Cytometry ◽  
Pilot Study ◽  
High Risk ◽  
Mayo Clinic ◽  
Detection Rate ◽  
Off Label Use ◽  
Color Flow ◽  
Off Label ◽  
Best Responses

Abstract Background Multiple myeloma (MM) consistently has a precursor state. High risk smoldering myeloma (SMM) or “early myeloma” has a 72-76% risk of progression at 5 years. In this phase II single arm pilot study, we report the results based on the completed enrollment of high risk (Mayo clinic or PETHEMA models) SMM patients treated with CRd (carfilzomib (CFZ), lenalidomide (LEN), and dexamethasone (DEX) followed by 2 years of Ln extended dosing. Methods This phase II single arm study treats high risk (Mayo clinic or PETHEMA models) SMM patients ≥18 years old with 8 cycles of CRd therapy. Dosing schedule consists of 28-day cycles of CFZ 20/36 mg/m2 IV on days 1, 2, 8, 9, 15, 16; LEN 25 mg PO daily on days 1-21; and DEX 20/10 mg IV/PO on days 1, 2, 8, 9, 15, 16, 22, 23. After 8 cycles of induction, patients with SD or better response receive LEN extension at 10 mg daily on days 1-21 for 2 years. The primary endpoint is response rate with the secondary endpoints of progression free survival, duration of response, and correlative assays focusing on minimal residual disease (MRD). Patients are evaluated for clinical biomarkers, FDG-PET CT, and MRD studies (flow cytometry and VDJ sequencing of bone marrow aspirates) at regular intervals. Flow cytometry utilizes an 8-color flow panel and analyzes ≥3 x 106 events (sensitivity detection rate of 1 x 10-5). Results Twelve patients (42% males; median age 58, range 48-65) meeting eligibility criteria have been enrolled onto study and are evaluable for toxicity and response. Eleven patients met high risk SMM criteria by PETHEMA model alone, and one patient met criteria for both PETHEMA and Mayo Clinic models. Mean baseline serum M-protein was 2.1 g/dL (1.1-3.3). Best responses (n=12) after a median of 6 cycles of CRd-R delivered (range 2-14 cycles) are 5-sCR/2-CR/2-nCR (75%) and 3-VGPR (25%). Among the 7/12 (58%) that reached CR/sCR, median time to CR/sCR was 5 cycles. Nine patients have completed 4 cycles of CRd therapy with all 9/9 (100%) reaching at least VGPR or better response. Non-hematologic toxicities ≥ grade 3 include: rash 2(17%), CHF 1(8%), dyspnea 1(8%), LFT elevation 1(8%), creatinine increase 1(8%), and hyperglycemia 1(8%). Hematologic toxicities include lymphopenia 4(33%), thrombocytopenia 1(8%), leukopenia 1(8%), neutropenia 1(8%), and anemia 1(8%). All patients have thus far maintained their best responses and none have progressed to clinical symptomatic multiple myeloma. Overall the treatment regimen has been well tolerated with manageable toxicities; one patient discontinued after 6 cycles due to CHF. Among 7 CR/sCR patients, 6/7 (86%) are MRD negative based on high-quality 8-color flow cytometry (sensitivity detection rate of 1 x 10-5) of bone marrow aspirates. In addition, one nCR patient does not demonstrate evidence of abnormally immunophenotypic plasma cells using multi-parameter flow cytometry (post 8 cycles of CRd). Conclusions Among patients completing 4 cycles of CRd therapy, 100% have achieved a VGPR or better. High risk SMM or “early myeloma” may represent a key interventional time point before the development of debilitating complications including onset of end-organ damage. The enrollment for this pilot study has been completed; an expansion cohort for additional 16 patients just opened for enrollment. Updated results will be presented at the meeting. Larger clinical studies are needed to replicate and expand on these promising results. Disclosures: Off Label Use: The abstract discussess off-label use of carfilzomib and lenalidomide.

scholarly journals Oral idarubicin and prednisone for advanced, previously untreated, multiple myeloma: A pilot study

1996 ◽  
Vol 7 (5) ◽  
pp. 537-538
Author(s):  
S. Brugnatelli ◽  
A. Riccardi ◽  
G. Ucci ◽  
M. Petrini ◽  
M. Giordano ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Pilot Study

scholarly journals NETs analysed by novel calprotectin‐based assays in blood donors and patients with multiple myeloma or rheumatoid arthritis: A pilot study

2020 ◽  
Vol 91 (5) ◽  
Author(s):  
Magne Kristoffer Fagerhol ◽  
Egil Johnson ◽  
Jon‐Magnus Tangen ◽  
Ivana Hollan ◽  
Mohammad Reza Mirlashari ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Multiple Myeloma ◽  
Pilot Study ◽  
Blood Donors

r-HuEPO 40,000 U one time/week before high-dose melphalan allows a tandem autologous peripheral stem-cell transplantation without red blood cell transfusion in multiple myeloma patients: A pilot study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7103-7103
Author(s):  
M. V. Martino ◽  
G. Console ◽  
E. Massara ◽  
T. Moscato ◽  
I. Callea ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Pilot Study ◽  
Stem Cell Transplantation ◽  
Blood Cell ◽  
Induction Chemotherapy ◽  
High Dose ◽  
Transfusion Requirements ◽  
High Dose Melphalan ◽  
Rbc Transfusion

7103 Purpose: To decrease red blood cell (RBC) transfusion requirements during a tandem high-dose melphalan (HDM) for multiple myeloma (MM) patients (PTS), we conducted a pilot study to assess the effect of high-dose of recombinant human erythropoietin (rHuEpo) started during chemotherapy before the first HDM and autologous peripheral blood stem-cell transplantation (APBSCT). Patients and Methods: After induction chemotherapy with VAD, 14 consecutive PTS with MM, stage III, median age 58 years (range 42–62), were mobilized with cyclophosphamide (3–4 g/m2) to collect peripheral blood stem cells (PBSC) and entered a study consisting of two HDM (200 mg/m2) with APBSCT. Enrolled patients received rHuEpo (40,000 U subcutaneously one time/week) as soon as their hemoglobin (Hb) level fell <11 g/dl during induction chemotherapy. rHuEpo was continued at the same dose during PBSC collection and was reintroduced at the time of discharge after the first transplant up to the admission for the second one. If the Hb level exceeded 13 g/dl at any time, rHuEpo was withheld until the concentration decreased to <11 g/dl, at which time it was restarted. Results were compared to those of 20 tandem HDM and APBSCT performed in 15 consecutive historical MM controls matched for hematological parameters. Results: rHuEpo increased the hemoglobin (Hb) level from 10.1 ± 2.5 g/dl at diagnosis to 12.8 ± 2 g/dl at the time of the first HDM; no major adverse effects occurred. Compared to historical controls (46.6%, 7/15), RBC transfusion requirements were significantly lower for rHuEpo recipients (6.6%, 1/14) (P=0.00001). After the tandem HDM and APSCT, fewer RBC transfusions were needed: 3.3 and 1 RBC units for controls and rHuEpo recipients, respectively (P=0.006). Conclusion: The administration of high dose of rHuEpo during induction chemotherapy and interval beetween the first and second HDM cycle permit the realitazion of tandem chemotherapic program with a reduction of blood product support. No significant financial relationships to disclose.

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