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Chrysarobin

Epoetin Alfa

Epoetin alfa

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

The purpose of this study was to test the effectiveness and safety of PROCRIT (Epoetin alfa) at a higher starting dose (60,000 Units) once per week, followed by a less frequent dose (60,000 Units every two weeks) in patients with cancer and chemotherapy induced anemia.

This was an open-label, non-randomized, multicenter pilot study where patients who were receiving chemotherapy for non-myeloid malignancy (cancer) with a baseline hemoglobin (Hb) \<= 11 g/dL were enrolled. The primary objective of this pilot study was to estimate the hematologic responses for the dosing regimen of PROCRIT (Epoetin alfa), starting at a dose of 60,000 Units (U) administered subcutaneously (sc, under the skin) once per week (qw) for four weeks ("Phase A"), followed by a dose of 60,000 U every two weeks (q2w) ("Phase B") in patients with cancer and chemotherapy induced anemia. If, at any time during the study the Hb level rose to \>13 g/dL, PROCRIT (Epoetin alfa) therapy was held until the Hb reached \<=12 g/dL, then resumed at a reduced dose in both Phase A and Phase B. The dose was also reduced if a very rapid Hb response occurred (i.e. an increase of more than 1.3 g/dL in a 2-week period). The secondary objective of the study was to determine the incidence of anti-erythropoietin antibodies (anti-EPO Ab), at baseline and at end of study/early withdrawal in patients who had received a minimum of one dose of PROCRIT (Epoetin alfa). Rarely, anti-erythropoietin antibodies may form in patients who have some types of diseases (e.g., autoimmune diseases, rheumatoid arthritis, anemia of chronic disease), or in response to exposure to erythropoietin products such as Epoetin alfa necessitating discontinuation of the erythropoietin agent and medical treatment that may include blood transfusions.

Safety evaluations included clinical laboratory tests (hemoglobin and hematocrit), vital signs measurements (blood pressure), and incidence and severity of adverse events.

This study determined if higher initial weekly doses resulted in a higher initial response rate and/or a more brisk hemoglobin rise. Patients received PROCRIT (Epoetin alfa) 60,000 Units (U) once a week for 4 weeks. At Week 5 if hemoglobin increased by \>= 1 g/dL above baseline, the PROCRIT dose was changed to 60,000 U every 2 weeks for \<= 12 weeks. An additional PROCRIT dose was given if chemotherapy completed before Week 16.

Alternate Dosing of PROCRIT (Epoetin Alfa) in Patients With Cancer and Chemotherapy Induced Anemia

An Open-Label Pilot Study to Evaluate the Effects of Alternate Dosing of PROCRIT� (Epoetin Alfa) in the Treatment of Patients With Cancer and Chemotherapy Induced Anemia (60,000 Units Weekly for Four Weeks Followed by 60,000 Units Every Two Weeks)

Ortho Biotech Products, L.P.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Neoplasms

Immune System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Rare Diseases

Leukemia

Leukemia, Lymphoid

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia, Lymphocytic, Chronic, B-Cell

Quality of Life

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Ortho Biotech, Inc. Clinical Trial

The purpose of this study was to compare the effectiveness of epoetin alfa treatment on hemoglobin (Hb) response, quality of life (QoL), health care resource utilization and patient productivity when epoetin alfa was administered during chemotherapy to patients with mild anemia or after waiting until patients became moderately anemic. Patients with lymphoma, chronic lymphocytic leukemia (CLL) or Multiple Myeloma (MM) were studied.

This study was an open-label (patients and investigators knew what treatment was being given), randomized (patients were assigned to a treatment group by chance) study of lymphoma, chronic lymphocytic leukemia (CLL), or multiple myeloma patients. This study addressed the clinical and patient-management consequences of treating mild to moderate anemia (hemoglobin (Hb) between 10 and 12 g/dL). The design of the study compared the effect of treating higher Hb levels to current standard of care criteria on Hb levels, transfusion requirements, and patient reported outcomes (quality of life, health care resource utilization, and productivity). Patients were randomized according to their Hb levels. Two entry criteria were specified during the course of the trial. Initially, patients were enrolled with Hb levels \>= 11 g/dL and then randomized to receive 1) Immediate epoetin alfa treatment or 2) Observed after Hb levels fell below 11 g/dL. Epoetin alfa treatment was provided to the Observed group if and when Hb levels fell below 9.0 g/dL. Slow recruitment of patients in to the study resulted in a protocol amendment. Subsequently, if a patient presented with a Hb between 10 and 12 g/dL, the patient was randomized to the Immediate or to the Observed groups. Patients presenting with Hgb \> 12 g/dL but otherwise eligible, were not randomized until Hb dropped to \<=12 g/dL. Patients remained in the study for up to 36 weeks. Safety assessments were performed throughout the study and included obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. The starting dose of PROCRIT (Epoetin alfa) was administered subcutaneously (sc) as 40,000 Units (U) once weekly (qw). If after 3-4 weeks of therapy, the Hb did not increase by \> 1.0 g/dL, the dose was increased to 60,000 U sc qw. If at any time, the Hb rose above 15 g/dL on 2 consecutive evaluations, PROCRIT (Epoetin alfa) was stopped until the Hb dropped to below 13 g/dL and then resumed.

Effect of Epoetin Alfa on Hemoglobin, Symptom Distress, and Quality of Life in Patients Receiving Chemotherapy

The Effects of PROCRIT (Epoetin Alfa) on Hemoglobin, Symptom Distress, and Quality of Life During Chemotherapy in Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma Patients With Mild to Moderate Anemia

Ortho Biotech, Inc.

Nervous System Diseases

Peripheral Nervous System Diseases

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Neuromuscular Diseases

Antineoplastic Agents

Bortezomib

Chou Jia-Shan

Huang Shang-Yi

Background and objective

The introduction of a proteasome inhibitor bortezomib has significantly improved response rates and overall survival in patients with multiple myeloma (MM), and it has soon become the cornerstone of treatment in both newly diagnosed and relapsed/refractory settings. However, the incidence of peripheral neuropathy related to bortezomib (BiPN) is unignorable and which becomes an obstacle during treatment with bortezomib, either alone or in combination. Until now, there are no consistent findings regarding the risk factors that may cause BiPN. There is either lack of large scale study of BiPN in Taiwan. This study aims to clarify risk factors of BiPN using retrospective analysis in a large cohort with longer observation period as well as the relations between BiPN and gene polymorphisms, and to compare different routes in the incidence of BiPN.

Methods

This is a retrospective cohort study with a sample size of about 400 MM patients treated ever with at least one full cycle of bortezomib in the institution. All the patients enrolled need to be adults (≧20 years ) with measurable M-component in either blood or urine. The investigators will perform a retrospective chart review to collect clinical data, including anti-MM and concomitant medications, to evaluate the incidence and severity of BiPN in this cohort, as well as any meaningful risk factors contributed to BiPN. The investigators also plan to perform genotyping for the possible genetic factors associated with development of BiPN.

Expected contributions

The successful collaboration between clinical hematologist-oncologist and biopharmaceutical researcher would result in the concrete evidence of efficacy and safety of bortezomib in Taiwanese patients with MM. The findings in this large cohort study will unveil the risk factors of BiPN, including the administration routes and ethnicity. As results, the investigators would be able to provide the precision medicine-based bortezomib treatment strategy to MM patients in Taiwan.

Study of Risk Factors and Genetic Association With Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma

identified the record of peripheral neuropathy, neuropathy, numbness, tingling, weakness symptoms by chart review

National Taiwan University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alternate Dosing of PROCRIT (Epoetin Alfa) in Patients With Cancer and Chemotherapy Induced Anemia	NCT00338299	Anemia Chemotherapy	Epoetin alfa	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Effect of Epoetin Alfa on Hemoglobin, Symptom Distress, and Quality of Life in Patients Receiving Chemotherapy	NCT00524407	Chemotherapy Anemia Cancer	Epoetin alfa	18 Years -	Ortho Biotech Clinical Affairs, L.L.C.
Study of Risk Factors and Genetic Association With Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma	NCT03210753	Multiple Myelom...		20 Years -	National Taiwan University Hospital

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