
A Phase II Trial Comparing the Quality of Life, Tolerability and Toxicity of PEG Intron With INTRON®...
Multiple MyelomaMultiple myeloma is a rare form of malignancy in which neoplastic plasma cells accumulate in the bone marrow. Most malignant plasma cells continue to produce immunoglobulin. The activity of multiple myeloma can therefore usually be monitored easily by serial measurement of the serum paraprotein levels. Except for a few patients who receive a donor bone marrow transplant, multiple myeloma remains incurable despite intensive chemotherapy. Its course is typically marked by periods of active disease alternating with increasingly shorter remissions. Interferons are substances produced in human cells in response to a variety of stimuli, such as viral infection. When given to myeloma patients as part of maintenance treatment , interferon-alpha 2 b (INTRONA) has been shown to be of value in prolonging the periods of remission. Until now, INTRONA could only be given as injections under the skin, three times a week. Some patients experience flu-like symptoms with each injection, particularly early on during maintenance therapy. This, as well as the chronic fatigue and even depression that INTRONA can induce may considerably reduce the quality of life of myeloma patients on interferon, so much so that sometimes this useful adjunct to chemotherapy for myeloma has to be stopped. Recently, a new preparation of interferon namely pegylated interferon (PEG Intron) has become available. It has the advantage of being broken down much more slowly by the body and therefore only needs to be given once a week. This minimises the swings in blood interferon levels that may be responsible for some of the interferon side effects. The safety and superior tolerability of PEG Intron has already been demonstrated in patients with hepatitis C for which it now carries a licence, but not in myeloma patients. Here, we propose to study whether the quality of life and side effect profile of myeloma patients on PEG Intron is better compared to that of Intron®A. In the main study, consenting eligible myeloma patients who are well and have been established on INTRONA maintenance therapy for at least six weeks will be randomly allocated to receive PEG Intron for three months followed by INTRONA for 3 months, or to continue with INTRONA for 3 months followed by PEG Intron for 3 months. All patients will be monitored regularly for any side effects and will be asked to fill in a quality of life questionnaire at the beginning (i.e. before receiving the first randomised treatment) and at the end of each study period (i.e. at 3 and 6 months). Initially, we are aiming at enrolling 60 patients into this part of the study. In a smaller sub-study involving only 14 patients initially, we are proposing to investigate whether myeloma patients who need to be taken off Intron®A because of its side effects can tolerate PEG Intron more easily. Should their tolerance of PEG Intron also be poor we would stop the interferon maintenance therapy altogether. However, should PEG Intron be found to be acceptable to them, we intend to switch these patients back to the standard treatment at the end of six weeks treatment with PEG Intron to assess whether they have become more tolerant of Intron®A in the intervening period. Patients will again be monitored carefully for any side effects and will be asked to fill in three quality of life questionnaires (at 0, 6 and 12 weeks).

Sirolimus, Tacrolimus, and Methotrexate in Preventing Acute Graft-Versus-Host Disease in Patients...
Chronic Myeloproliferative DisordersGraft Versus Host Disease5 moreRATIONALE: Sirolimus, tacrolimus, and methotrexate may be effective in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation. PURPOSE: This phase I/II trial is studying the side effects of sirolimus when given together with tacrolimus and methotrexate and to see how well they work in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer.

Epoetin Alfa in Treating Anemia in Patients With Solid Tumors
AnemiaLeukemia6 moreRATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia. PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.

Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing...
Hematopoietic/Lymphoid CancerAccelerated Phase Chronic Myelogenous Leukemia135 moreRATIONALE: Beclomethasone dipropionate may be effective in preventing acute graft-versus-host disease in patients undergoing a stem cell transplant for hematologic cancer. PURPOSE: This randomized phase II trial is studying how well beclomethasone dipropionate works in preventing acute graft-versus-host disease in patients undergoing a donor stem cell transplant for hematologic cancer.

Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing...
Anxiety DisorderChronic Myeloproliferative Disorders5 moreRATIONALE: Music therapy may be effective in relieving pain and emotional distress in patients who are undergoing cancer therapy. PURPOSE: Randomized trial to determine the effectiveness of music therapy to ease pain and emotional distress in patients with hematologic cancer who are undergoing high-dose therapy and stem cell transplantation.

Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter...
Cervical CancerChronic Myeloproliferative Disorders8 moreRATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications. PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter.

Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving...
InfectionMultiple MyelomaRATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.

Fermented Milk Supplementation on Symptoms of Disease and Treatment in Patients With Multiple Myeloma...
Plasma Cell MyelomaThis trial investigates the effect of fermented milk supplementation on symptoms of disease and treatment in patients with multiple myeloma. Patients with multiple myeloma may experience symptoms related to the disease and/or treatment that affect quality of life. Supplementing usual diet with a probiotic fermented milk product called kefir may contribute to reducing disease and treatment-related side effects through changing the intestinal bacteria community structure and related metabolism.

Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple...
CancerHematologic Malignancies4 moreThe purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.

Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
Brain and Central Nervous System TumorsChronic Myeloproliferative Disorders10 moreRATIONALE: An Opioid Titration Order Sheet that allows healthcare providers to adjust the dose and schedule of pain medication may help improve pain treatment for patients with cancer. It is not yet known whether the use of an Opioid Titration Order Sheet is more effective than standard care in treating pain caused by cancer. PURPOSE: This randomized phase III trial is studying an Opioid Titration Order Sheet to see how well it works compared with standard care in treating patients with cancer pain.