Symptoms and General Pathology

All Conditions

Digestive System Diseases

Diarrhea

Enteritis

Signs and Symptoms, Digestive

Gastroenteritis

Gastrointestinal Diseases

Intestinal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Analgesics

Antitussive Agents

Central Nervous System Depressants

Respiratory System Agents

Herbal and Botanical

Loperamide

Antidiarrheals

Opium

Opium Poppy

Treamtment with opii normata in case of diarrhea

Treatment with Loperamid in case of diarrhea

After beginning of diarrhea grade 1:

5 drops tincture of opium three times a day

After beginning of diarrhea grade 2:

Intensive therapy with 15 drops tincture of opium three times a day.

Opii normata treatment

All patients who receive as a result of randomisation loperamide

After beginning of diarrhea grade 1:

Initial 4mg and 2mg after any unformed stool. The maximum dose amounts to16mg per day.

After beginning of diarrhea grade 2:

Intensive therapy with 2mg loperamide every 2 h. The maximum dose amounts to 16mg per day.

Loperamid Treatment

Michael Bieker, MD

Therapy-associated diarrhea during radiation therapy of small pelvis (including enteritis as a result of radiation therapy and enteritis as a result of radiation- and chemotherapy) is a common problem in multimodal cancer therapy. We investigate the therapeutic effect of either loperamide or tinctura opii in therapy- associated diarrhea in patients who receive radiation therapy of the small pelvis with or without chemotherapy.

Comparision between treatment with Tinctura Opii normata and Loperamid in patients with therapy-associated diarrhea during radiaton therapy of small pelvis

Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -

Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium

In this study efficacy of loperamide and tincture of opium is linked to the respective proportions of patients where diarrhoea of grade \> 2 is successfully averted during (cancer) therapy.

Quality of life will be assessed with the EORTC-QLQ C30 questionnaire

The quality and quantity of diarrhea will be assessed with a questionnaire

Maros Arznei GmbH

Philipps University Marburg Medical Center

Neoplasms

Blood and Lymph Conditions

Fatigue

Hematologic Neoplasms

Hematologic Diseases

Patients recieve an 11-week mind-body medicine group program including elements of mindfullness based stress reduction (MBSR), yoga, and education + treatment as usual.

The group program is mainly based on MBSR. It further integrates elements of the mind-body medicine cancer program of the Benson-Henry Mind/Body Medical Institute at Harvard Medical School which is rooted in psychoneuroendocrinology and focuses on relaxation techniques, exercise, cognitive restructuring, diet, and social support. In addition, naturopathic methods of selfregulation and self-care are incorporated.

Mind-body medicine group program

Holger Cramer, PhD

Heidemarie Haller, PhD

Walter E. Aulitzky, Prof. MD

Maria M. Winkler

Gustav Dobos, Prof. MD

This randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases.

Mind-body Medicine for Patients With Malignant Hematological Diseases

Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial

Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale

Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale

Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale

Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale

Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale

Functional Assessment of Cancer Therapy - General (FACT-G)

Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)

Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)

Robert Bosch Medical Center

Universität Duisburg-Essen

Research Director

Heart and Blood Diseases

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasm Metastasis

Immunologic Deficiency Syndromes

Syndrome

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Neoplastic Processes

Participants with MM diagnosed with SID will be treated with HyQvia as part of routine clinical care and will be followed prospectively from the date of starting HyQvia treatment through 12 months of follow-up.

As this is an observational study, no intervention will be administered in this study.

No Intervention

Takeda Contact

Site Contact

Emanuel Leonardo Aguilera

Alexandra Jungova

Jan Straub

Clement Gourguechon

Marie-Lorraine Chretien

Katell Le Du

Omar Benbrahim

Jean-Francois Viallard

Richard Schabath

Efstathios Kastritis

Ioanna Sakellari

Angelo Vacca

Alessandra Romano

Tamara Berno

Francesco Cinetto

Jacek Rolinski

Sorina Badeelita

Ciprian Tomuleasa

Luminita Ocroteala

Alina Camelia Catana

Silvia Sanchez-Ramon

Joaquin Martinez-Lopez

Albert Perez-Montana

Goran Jonson

Karlis Pauksens

Selami Toprak

Volkan Karakus

Muhlis Cem Ar

Omur Sevindik

Study Director

In this study, multiple myeloma participants with secondary immunodeficiency (SID) will be treated with HyQvia according to their clinic's standard practice. The study's main aim is to look into infusion parameters of HyQvia administration.

This is a prospective, observational study of adults having multiple myeloma (MM) with SID treated with HyQvia as part of routine clinical care. This study will characterize the real-world infusion parameters of HyQvia administration.

The study will enroll approximately 100 participants.

Study data will be requested through participants' routine clinic visits and patient-reported outcome (PRO)s are voluntary.

This multi-center trial will be conducted in selected European and Latin American countries. The overall time of this study is 38 months. Participants will make multiple visits to the clinic 12 days after last dose of study drug for a follow-up assessment.

Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency

A Prospective, Observational Study to Assess the Real-World Usage and Outcomes of HyQvia in Patients With Multiple Myeloma (MM) Diagnosed With Secondary Immunodeficiency (SID)

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Dose of HyQvia will be calculated as grams per kilogram (g/kg) body weight per 4 weeks.

Absolute dose of HyQvia will be calculated as dose per infusion in milliliters (mL).

Treatment interval and ramp up dosing intervals will be reported as Weekly, every 2 weeks, 3 weeks, 4 weeks and other administration according to the schedule defined by physician.

Infusion rate will be reported in milliliters per hour (mL/h).

The duration between start and end of infusion will be reported.

Location of infusion sites will include right upper abdomen, left upper abdomen, right lower abdomen, left lower abdomen, right or left thigh, right or left arm, and other (specified).

Site of care will be categorized as home, hospital, doctor's office, other (specified).

Type of pump will include peristaltic infusion pump and syringe driver pump.

Availability of caregiver support will be collected as yes, no, and unknown. If yes, caregiver relationship will be specified.

Reasons for discontinued, or interrupted HyQvia treatment will include local adverse events (AE)/discomfort, systemic AE, administration complexity, lack of efficacy, insurance/reimbursement-related, low immunoglobulin trough level, lack of effectiveness, inability to tolerate large volumes and other (specified). If switch, type of treatment after switch (e.g., antibiotic treatment, intravenous immunoglobulin \[IVIg\], subcutaneous immunoglobulin \[SCIg\], etc.) or switches to other treatment will be included.

Clinical characteristics of participants will include type of MM, and MM treatment/procedures, comorbidities, concomitant medications, laboratory tests and imaging.

Type of hemato-oncological treatment will list type, switches, interruptions and discontinuation with reasons of hemato-oncological treatment or procedure.

MM disease status and outcome will include response and criteria used to assess response (if known).

OS will be summarized as the frequency and percentage of participants surviving to each follow-up visit. Additionally, time-to death, defined as the time from HyQvia initiation to death occurring before the end of the study period, will be assessed.

Number of participants with HCRU including annualized rates and emergency room visits, urgent care visits, outpatient visits, telemedicine visits, and other physician visits, with stratification of hospitalizations and visits due to infection, visit type and provider type.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence that at any dose is fatal, life-threatening, requires inpatient hospitalisation or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. AEs will be reported as local or systemic AEs.

Premedication use for HyQvia infusions will include start date, stop date and medication name. Technical problems with infusion will include problems with the handling of the pump, problems with the preparation of the infusion, problems with the infusion itself, infusion site leakage, and other (specified).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -	NCT00444093	Diarrhea Enteritis Cancer	Opii normata tr... Loperamid Treat...	18 Years -	Philipps University Marburg Medical Center
Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -	NCT00444093	Diarrhea Enteritis Cancer	Opii normata tr... Loperamid Treat...	18 Years -	Philipps University Marburg Medical Center
Mind-body Medicine for Patients With Malignant Hematological Diseases	NCT03735992	Hematologic Neo...	Mind-body medic...	18 Years -	Universität Duisburg-Essen
Mind-body Medicine for Patients With Malignant Hematological Diseases	NCT03735992	Hematologic Neo...	Mind-body medic...	18 Years -	Universität Duisburg-Essen
Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency	NCT05879757	Multiple Myelom... Secondary Immun...	No Intervention	18 Years -	Takeda

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