Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Daratumumab

40 patients with Multiple Myeloma in Department of Hematology at Odense University Hospital, Denmark

Investigate the home administration of Darzalex SC reported by both patients and healthcare professionals compared to the hospital administration setting.

Darzalex

Karin Dieperink, RN, PhD

Multiple myeloma (MM) is the second most common hematological disease in Denmark with an incidence of approximately 350 diagnosed cases per year. There is no curative treatment yet, but usually the disease is very sensitive to treatment, and patients have periods of varying length, where they do not require treatment. Thus the prognosis for MM has improved over recent years, and the rate of survival has been extended for both younger and elderly patients. With the increasing specialization and centralization that will occur in the coming years, some patients will have very long transport times to the hospital. When patients go to the hospital only to receive their anticancer therapy, their visits are relatively short and the amount of time spend on transportation might appear disproportionate. The frequent hospital appointments increase the patient's exposure for bacteria and viruses which should be calculated as a potential risk. Furthermore if the patient is an active part of the labor market, it can be challenging to request freedom to hospital visits.

It is thus possible to provide the treatment at home, but it is unknown what significance it has for patients, relatives and health professionals as well as for the economy it is thus possible to provide the treatment at home, but it is unknown what significance it has for patients, relatives and health professionals as well as for the economy. The aim of this project is to investigate the home administration of Daratumumab SC reported by both patients and healthcare professionals compared to the hospital administration setting. Furthermore, this project investigates the hypothesis that the home administration of Daratumumab potentially can reduce the time associated with the administration, thereby, resulting in a socio-economic gain.

The aim for this study: We want to examine patients 'and healthcare professionals' perspectives, the organizational and the socio economic aspects of administering subcutaneous Daratumumab in their own home to patients with multiple myeloma, and to illuminate the benefits and challenges of this.

This study is a prospective, non-randomized, clinical parallel mixed-methods intervention project using qualitative and quantitative data in the form of semi-structured telephone interviews, focus group interviews, time registration, registration of patients' contact with the healthcare system and PRO data. The project will both include patients already being treated with SC Daratumumab and new patients planned to start Daratumumab treatment = 40 patients in all. The patients will be included in the department of hematology Odense University Hospital as they are found eligible.

The intervention of the study is home administration of Daratumumab SC by a home nurse, thereby, changing the administration setting from a hospital setting to at home setting. The intervention with home administration will be compared to the hospital setting. The patients will function as their own controls, as treatment will be given alternately at the hospital.

Patients scheduled for Daratumumab SC at home will be phoned by a nurse from the Hematology Outpatient Clinic the day before planned administration. This procedure is chosen as that it allows the nurse to determine whether it is justifiable, for the patient to receive treatment at home. If the nurse and doctor assess that the patient is fit for home administration of Daratumumab SC, the drug will be ordered at the pharmacy to be delivered to the patient the following day. Also an electronic message will also be sent to the home nurses with an instruction to administer Daratumumab SC between 12-02 PM.

Data collection will consist of:

* Semi-structured virtual (or alternative telephone) interviews with participating patients focusing on benefits / gains versus challenges / disadvantages in regard to the actual injection, collaboration with the home nurse, delivery of medication, empowerment, and suggestions for further improvements n = 2 x 10
* Semi-structured interviews with involved home nurses n = 1 x 5.
* Focus group interview with health professionals involved at OUH at the end of the project n = 1.
* Registration of unplanned contact to the health service during the study period to account for any extra health care usage during home treatment via the app "My hospital" x 1 weekly n = 40
* Data on quality of life; EORTC custom built satisfaction questionnaire via the app "My hospital" = 5 times per patient.
* Registration of the patients evaluation of whether the use of the app "My hospital" can be useful in the future.
* Registration of patients' time used on treatment when at home or when at hospital including transport via the app "My hospital".
* Registration of the outpatient nurses' and home nurses time using the registration form via paper.
* Registration of patients general condition and possible side effects in order to clarify whether they are "fit" for treatment via the app "My hospital". This ensures that a cure that is not used is not prepared.

All Suspected Unexpected Serious Adverse Reactions (SUSARs) will be reported to the Danish National Health Authorities according national law within 7 days after awareness. Since this is not at clinical trial, but merely a collection of data during a different logistics setup, the study will be submitted to the Danish Data Protection Agency, however not to the Danish National Ethical Committee nor the Danish National Health Authorities. Due to this Adverse Reactions (AEs) will not be systematically registered or reported to the Danish national health authorities. To make sure the logistics setup is safe for all patients we will register all unplanned hospitalizations as well as all other related Serious Adverse Reactions (SAR).

Processing of personal data in the project The project is notified to the Region's Register so that it complies with the Data Protection Regulation (GDPR). All electronic data will be stored on a secure SharePoint site that can only be accessed via the project group's work computer. All physical material is stored behind double-locked doors at the project group's workplace.

Daratumumab Provided at Home Experience An Open, Single-center, Mixed-method Project.

Daratumumab Provided at Home Experience: An Open, Single-center, Mixed-method Project Initiated on Behalf of Odense University Hospital

To analyse changes in QoL measured by EORTC IL90

Examination of patients' time spend on treatment in minutes through an app on a smartphone.

Examination of healthcare professionals' time spend on treatment in minutes on paper

Examination of healthcare professionals' satisfaction using focus group interview at end of study

Examination of financial perspective through calculations healthcare salaries based on time spend on treatment and transportation of medicatoin and/or patients through analysis of quantitative data

Thomas Lund

Principal Investigator

Leukemia

Leukemia, Myeloid, Acute

Leukemia, Myeloid

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Pharmaceutical Solutions

Cytarabine

Idarubicin

DARZALEX®

Dose level 1 : 1800 mg Day 1 Dose level 2 : 1800 mg Day 1 and 8 (+/- 2 days) Dose level 3 : 1800 mg à Day 1, 8 (+/- 2 days) and D15 (+/- 2 days)

DARZALEX® = Daratumumab. Solution for injection, 1800 mg/15 mL, single vial. Sub-cutaneous administration.

* Dose level 1 : 1800 mg Day 1
* Dose level 2 : 1800 mg Day 1 and 8 (+/- 2 days)
* Dose level 3 : 1800 mg à Day 1, 8 (+/- 2 days) and D15 (+/- 2 days)

PIERRE PETERLIN

MATHILDE HUNAULT

MARC BERNARD

To search for a Maximum Tolerated Dose (MTD) for the combination of daratumumab and induction chemotherapy with Idarubicin and cytarabine in patients with Acute Myeloblastic Leukemia (AML) of poor prognosis

Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM)

Multicentric Phase 1 Study With Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM)

Dose at which no toxic effect is observed, by determination of the LDT (Toxic Limit Dose). A TLD is defined by the occurrence of grade ≥ 3 daratumumab related toxicity that is not reversible after 7 days (except for haematological toxicity) or the absence of emergence from aplasia at D45 of induction (in the absence of treatment failure). Toxicity is assessed according to NCI-CTCAE version 5 criteria. The search for DLT is continued until D45 of induction.

calculation of the rate of complete remission (CR) with negative residual disease (CR MRD-), CR, CR with incomplete haematological recovery (CRi), MLFS (morphological leukemia free state), partial response (PR) or treatment failure according to the 2022 NLE definition between D30 and D45.

Neutrophil recovery time (\>1.0 × 109/L) from D1 - Recovery time of platelets (\>100 × 109/L) from D1

time from D1 of induction to date of last contact or death

time from D1 of induction to date of relapse, death or date of last

Nantes University Hospital

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunologic Factors

Blinded period: BCD-264 (daratumumab) will be administered intravenously once weekly for the first 8 weeks (Cycles 1 and 2), then once every two weeks for 16 weeks (Cycles 3, 4, 5 and 6). The total duration of the blinded treatment period is 6 cycles.

Open-label period: starting from Day 1 of Cycle 7, the subjects will receive open-label BCD-264 once every 4 weeks

Blinded period: Darzalex (daratumumab) will be administered intravenously once weekly for the first 8 weeks (Cycles 1 and 2), then once every two weeks for 16 weeks (Cycles 3, 4, 5 and 6). The total duration of the blinded treatment period is 6 cycles.

Open-label period: starting from Day 1 of Cycle 7, the subjects will receive open-label BCD-264 once every 4 weeks

BCD-264

Alexander Korobkin

Tatiana Konstantinova

Marina Kosinova

Elena Martynova

Elena Misyurina

Vadim Doronin

Yuri Osipov

Ilya Zyuzgin

Sergei Voloshin

Ivan Moiseev

Margarita Ulyanova

Igor Davydkin

Dmitrii Kirtbaya

Bulat Bakirov

The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy.

A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma

A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex® in Subjects With Relapsed and Refractory Multiple Myeloma

Biocad

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Lenalidomide

Dexamethasone acetate

Patients either continue DRd with daratumumab iv, switch to daratumumab sc or switch multiple times iv/sc

Patients either continue DRd with daratumumab sc, switch to daratumumab iv or switch multiple times sc/iv

Wolfgang Knauf, Prof. Dr.

MYLENE is a prospective, multicenter, NIS to evaluate the patient and HCP satisfaction of sc and iv application of daratumumab in routine clinical practice in Germany. Patients observed in this study will be transplant ineligible NDMM patients for which the physician foresees an anti-myeloma therapy using DRd regimen as per local label.

250 NDMM patients treated with DRd will be enrolled (excluding screening failures, i.e., enrolled patients not fulfilling selection criteria identified before treatment start will be replaced) within 12 months in a proportion of approximately 1/3 patients receiving daratumumab sc and 2/3 patients receiving daratumumab iv as per physician's decision.

Therapy options for MM are mainly dependent on the age and fitness of the patients. NDMM patients up to the age of 65-70 years in whom autologous stem cell transplantation is not indicated, anti-myeloma treatment traditionally consists of systemic chemotherapy, with adjunctive use of radiation or surgery in selected cases associated with extramedullary disease. However, the therapeutic landscape of multiple myeloma progressed in the past decade with the introduction of immunomodulatory agents, proteasome inhibitors and anti-CD38 antibodies, like Daratumumab.

After approval of daratumumab iv in May 2016, the sc daratumumab application route was approved in June 2020 in Germany. Real-world evidence data, however, are not yet available neither related to daily experience nor to satisfaction with daratumumab sc application nor to the proportion of patients potentially switching from daratumumab iv to sc application.

MYLENE aims to close these gaps with focus on NDMM patients who are ineligible for autologous stem cell transplantation and who will be treated with DRd; this is to guarantee a homogenous patient population.

All aspects of treatment and clinical management of patients will be in accordance with local clinical practice and applicable local regulations, and at the discretion of the healthcare provider (or treating physician where different). Only data available per clinical practice will be collected within this study. Additionally, where permitted in accordance with local regulations, healthcare providers will be asked to obtain patient-reported outcome (PRO) data from patients within this study. Despite use of PROs and HCP as well as physician questionnaires, the design is non-interventional due to the fact that the questionnaires are structured documentation aids to document questions that are routinely part of the dialog between patient and physician or HCP during the patient visit and/or drug administration or that are considered by the HCP when evaluate treatment for the patient but are not documented in the medical record.

MYLENE is unique as it is focusing on the satisfaction of all involved stakeholders (i.e., patients and HCPs) under real-word conditions and mainly in private practices, since this patient collective is treated preferentially in these institutions, allowing to receive direct feedback about the use of daratumumab sc application and its potential hurdles or/and limitations. Furthermore, this study will provide insights on how the sc/iv application is managed in clinical routine as well as how it is perceived by medical professionals over time.

This NIS will be analyzed exploratively and is hence not designed to confirm or refute a predefined hypothesis.

Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients in Germany Depending on Application Route (sc or iv)

Prospective, Multicenter, Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients as Per Routine Clinical Practice in Germany Depending on Application Route (sc or iv)

Occurence and number of patients with (treatment-related) adverse events will be provided.

Additionally, summary tables of selected subsets of AEs will be displayed summarized by system organ class (SOC) and preferred term (PT), sorted by frequency of SOC and PT. Summary tables for AEs will include only AEs that started or worsened during the on-treatment period. However, safety data from the pre- and post-treatment periods will be listed separately.

Time to first occurrence of AESI will be calculated for patient with an AESI as the time from the date of first application of daratumumab until onset of first documented AESI and will displayed with descriptive statistics.

The primary objective of this NIS is to exploratively analyze patients' satisfaction of sc and iv application of daratumumab over time as measured by the "Patient Satisfaction and Time Questionnaire" (PatSTQ).

Overall patients´ satisfaction with daratumumab administration will be displayed as the result of one defined question in the PatSTQ, with descriptive statistics and boxplots.

Results of PatSTQ will be displayed with frequencies per group and by time point. Additionally, stacked bar plots with questionnaire results (including missings) per item and time point will be presented

The secondary objective of this NIS is to assess HCPs' satisfaction of sc and iv application over time as measured by the "HCP Satisfaction and Time Questionnaire - patient specific" (HSTQ-ps).

HCPs' application route satisfaction will be displayed by questionnaire time point as result of the HSTQ - ps questionnaire with frequencies for questions and with descriptive statistics.

The proportion of HCP active time spent on activities (drug preparation, drug administration, patient care/patient monitoring) over time

Patients' overall time spent at doctor's office

The switch rate (proportion of patients) of daratumumab application routes during 12 months of study participation under real-word conditions

The main reasons for sc or iv application selection evaluated by both, the "Physician Therapy Decision Questionnaire - general" (PTDQ-g) at study start and at the end of study (i.e., study close-out) and by the "Physician Therapy Decision Questionnaire - patient specific" (PTDQ-ps) at baseline and at switch of the application route

The impact of different factors on therapy decision and application route selection will be displayed as parameter estimates for selected fixed covariates (age, cytogenetics (high vs standard) and relevant comorbidities) in a mixed effects logistic regression model with the result of PTDQ-ps as outcome.

The treating physician selects up to two main reasons why the (new) application route (sc or iv) of daratumumab for a patient is chosen.

Patients' preference of the application route (only for patients switching from one application route to another) as measured by the "Patient Preference Questionnaire" (PatPQ).

The patient selects which method of daratumumab administration (iv or sc) is preferred and up to two reasons for the preference.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Daratumumab Provided at Home Experience An Open, Single-center, Mixed-method Project.	NCT05306587	Multiple Myelom...	Darzalex	18 Years -	Odense University Hospital
Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM)	NCT05749276	Adult Patients ...	Darzalex	60 Years -	Nantes University Hospital
A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma	NCT06296121	Multiple Myelom...	BCD-264 Darzalex	18 Years -	Biocad
Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients in Germany Depending on Application Route (sc or iv)	NCT05284591	Multiple Myelom... Newly Diagnosed Transplant Inel... Patient Satisfa... Patient Prefere... Personal Satisf...	Daratumumab	18 Years -	iOMEDICO AG

Spots Global Cancer Trial Database for darzalex

Every month we try and update this database with for darzalex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for darzalex

Every month we try and update this database with for darzalex cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for darzalex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.