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

Any MMY treatment Any line of treatment for MMY

Any MMY treatment

Janssen Pharmaceutica N.V. Clinical Trial

The primary objective of this observational study is to document and describe current treatment regimens and disease progression of patients with Multiple Myeloma (MMY). The aim of this registry is to provide accurate, descriptive information on the way Multiple Myeloma is treated in routine clinical practice. The registry will collect information related to the treatment received for Multiple Myeloma. About 3000 patients will take part in the study in about 28 countries. The registry will only collect information that is already in medical files regarding treatment. Patients will not be required to actively do anything in addition to what would be done without participating in this registry, nor will there be any procedures or interventions that are not already part of the current treatment.

There is a lack of objective data relating to variation in treatment practices and resource utilisation for Multiple Myeloma (MMY) patients between countries. This void continues to hamper attempts to create meaningful health economic models for MMY treatment and impedes understanding of the MMY clinical arena. This non-interventional observational study is designed to address the problem by providing a definitive picture of routine treatment and resource utilisation practices for MMY patients at any stage of treatment, independent of drug(s) used and treatment line across the different countries taking part. A non-interventional study design has been selected to facilitate data collection about routine clinical practice. This study seeks to obtain an appropriate subset of the true population of patients with MMY throughout Europe Middle East and Africa. Many concerns exist when attempting to develop an unbiased study sample, including biases regarding the selection of patients to be enrolled. Therefore, a multi-staged site and patient selection model will be used to reduce biases associated with patient and site selection. The study seeks to enroll at least 3,000 patients. It will deliver a description of everyday treatment practice of MMY. Additional retrospective medical reviews will also be performed to collect information regarding disease history. The primary objective of the study is to document and describe current treatment regimens and disease progression of patients with MMY. Secondary objectives of the study involve understanding the MMY patient population and its generalisability to all treated MMY patients. Additional goals of the study are to document and compare: (a) utilisation of current treatment regimens for MMY; (b) quality of life and health economic parameters associated with MMY treatment regimens; (c) the safety profile of current treatment regimens for MMY and the impact on resource utilisation; (d) the effectiveness of current treatment regimens for MMY. The study will collect prospective data on efficacy, outcomes, health economic and safety parameters for all patients whenever available. The resulting database will allow future health economic, pharmaco-epidemiological, and outcomes research, and provide important data from the clinical arena. At least 3000 patients will be recruited to this study. As this is an observational study, the decision of patients to take part in this study will not have any impact on the care they are receiving. All treatment decisions will be made at the discretion of the participating physicians. Only data available from routine clinical practice will be collected. There are two phases of data collection in this study: (a) at baseline, the patient's historical treatment and resource utilisation data, where possible stretching back to diagnosis, will be recorded via electronic data capture; (b) following the baseline visit, the patient will enter a prospective data collection phase where data will be collected at least every three months. At each data collection point, all changes since the previous data collection point will be collected. Prospective data collection will continue until the study is complete or the patient is withdrawn from the study. Data will continue to be captured until three years after the last patient is recruited to the study. Interim analyses will be conducted at least annually to update the current data. To monitor the safety profile of MMY treatment related to a Johnson and Johnson product, any unwanted effects that occur during the MMY treatment will be recorded Observational Study - No investigational drug administered

A Study to Record in an Observational Manner the Treatment of Multiple Myeloma as it is Being Done in Every Day Practice Without Providing Any Investigational Drug or Prescribing Any Procedure

An Observational Study of the Treatment of Multiple Myeloma in Routine Clinical Practice

Janssen Pharmaceutica N.V., Belgium

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

* Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks for up to 22 cycles
* Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles
* Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles

• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 22 cycles

• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 6 cycles

• Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles

Sandro Pignata, M.D., Ph.D.

Nicoletta Colombo, M.D.

Francesco Perrone, M.D., Ph.D.

Gennaro Daniele, M.D., Ph.D.

Roldano Fossati, M.D.

Ciro Gallo, M.D.

Irene Floriani, Ph.D.

The addition of bevacizumab to first-line chemotherapy has been shown to improve progression free survival for patients with ovarian cancer. The purpose of this study is to explore the potential role of clinical and biologic factors in identifying those patients who benefit most from this combined therapy in terms of progression free and overall survival.

MITO-16 - MANGO-OV2 is a single-arm, open-label, non-comparative, multicenter, phase IV study. Patients will receive a combination of bevacizumab, paclitaxel and carboplatin as first line treatment (in-label dose and scheduling). This is an exploratory study attempting to identify potential prognostic clinical factors(such as hypertension) and prognostic biologic factors. Overall, 2 types of biomarkers are considered. Dynamic biomarkers are those expressing the changing nature of the disease in relation to the treatment or simply the tumour progression, these are typically not inherited. Genetic biomarkers are typically inherited and are expression of some characteristics potentially able to interfere with the treatment effect (i.e. Pharmacogenomics).

The safety of this regimen in routine clinical practice will also be described.

Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab

A MULTICENTER STUDY IN PATIENTS WITH STAGE III-IV EPITHELIAL OVARIAN CANCER TREATED WITH CARBOPLATIN/PACLITAXEL WITH BEVACIZUMAB: CLINICAL AND BIOLOGICAL PROGNOSTIC FACTORS

according to Common Toxicity Criteria for Adverse Events v. 4.03

Mario Negri Institute for Pharmacological Research

National Cancer Institute, Naples

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Wounds and Injuries

Nervous System Diseases

Synovitis

Giant Cell Tumors

Giant Cell Tumor of Tendon Sheath

Synovitis, Pigmented Villonodular

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Joint Diseases

Tendinopathy

Muscular Diseases

Pigmented Villonodular Synovitis

Global Clinical Leader

TGCT is a rare disease that is difficult to manage, surgical resection is the primary treatment currently available. To date no disease registry exists and there is little data available detailing the management of patients with diffuse TGCT (d-TGCT), the burden of d-TGCT for patients (including pain, joint stiffness, swelling, reduced mobility and quality of life) or the economic impact of d-TGCT.

This study aims to collect data by an observational disease registry involving no intervention to the patient or changes to investigators treatment decisions.

GCT is a rare, benign, but potentially locally aggressive and recurrent disease. Treatment pattern and treatment initiation, continuation or changes are solely at the discretion of the physician and the patient.

There will be no attempt to influence the prescribing patterns of any individual treating physician. All medication will be prescribed in the usual standard of care and will not be provided by the study sponsor.

Participation in the study will in no way influence payment or reimbursement for any treatment received by patients during the study.

It is the responsibility of the investigator and his study staff to enter all relevant patient data required for this registry in the electronic Case Report Form (eCRF) and in the patients' medical records.

Approximately 15 sites from up to 6 European Countries (France, Germany, Italy, The Netherlands, Spain and United Kingdom) and 4 sites from the US are planned to participate. The sites will be specialized sites that treat d-TGCT regularly.

Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project

A Disease Registry for Patients With Tenosynovial Giant Cell Tumors (TGCT), Also Known as Pigmented Villonodular Synovitis (PVNS) and Giant Cell Tumor of the Tendon Sheath (GCT-TS)

The management plan received among the patients was collected from information routinely recorded in the patient files / medical records.

The current TGCT treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.

Type of treatment plan received among the patients was collected from information routinely recorded in the patient files / medical records.

The status of treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.

Type of current TGCT treatment among the patients was collected from information routinely recorded in the patient files / medical records.

Tumor severity classification was collected from information routinely recorded in the patient files / medical records. ). Tumor severity classification was based on MRI. In this classification scheme, moderate diffuse TGCT is characterized by intra- and/or extra-articular disease, without or with involvement of muscle/tendinous tissue/ligaments. Severe diffuse TGCT is characterized by intra- and extra-articular involvement and involvement of at least one of the 3 structures (muscle/tendinous tissue/ligaments).

Complications due to surgery were collected from information routinely recorded in the patient files / medical records.

Tumor recurrence was collected from information routinely recorded in the patient files / medical records.

Time since most recent tumor recurrence was collected from information routinely recorded in the patient files / medical records.

Time from baseline to first tumor recurrence was collected from information routinely recorded in the patient files / medical records.

The BPI short form is a self administered questionnaire that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. The BPI pain severity and interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes), where lower scores indicate better clinical outcome.

The Worst Stiffness numerical rating scale (NRS) is a one-item self-administered, patient-reported outcome questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranges from 0 ("no stiffness") to 10 ("stiffness as bad as you can imagine"), where lower scores indicate better clinical outcome.

PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health. Physical function scores range from 0 (worst physical function) to 100 (best physical function, where higher scores indicate better clinical outcome.

The EQ-5D-5L questionnaire measures the patient's quality of life (QoL) based on the 5 dimensions mobility, self care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D index score ranges from 0 (worst QoL) to 1 (best QoL), where lower scores indicate worse clinical outcome. The EQ-5D VAS reports patient's self rated health ranging from 0 (worst health) to 100 (best health you can imagine), where lower scores indicate worse clinical outcome.

Health resource utilization was assessed by mean number of general practitioner visits, specialist visits, and physical therapy sessions. In addition, the mean number of days in rehabilitation and the number of work days missed were also reported.

The median number of days in rehabilitation and the number of work days missed were also reported.

TGCT outcome status was collected from information routinely recorded in the patient files / medical records.

Optimapharm

Daiichi Sankyo

Treatment-emergent adverse events and serious adverse events were not assessed in this non-interventional study. Adverse drug reactions suspected to be related to pexidartinib were only collated for patients from the United States.

All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled in the study.

Overall

Tenosynovial Giant Cell Tumors

Age, Continuous

<40 years

≥40 and <60 years

≥60 years

Age, Customized

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Austria

Netherlands

United States

Italy

United Kingdom

France

Germany

Spain

Region of Enrollment

Knee joint

Ankle joint

Shoulder joint

Foot

Elbow joint

Wrist joint

Hand

Temporomandibular

Tumor location/affected joint

Pain

Limited range of movement

Swelling

Stiffness

Patient unable to judge

Current symptoms

Not applicable

Missing

Most disturbing symptom

4 current symptoms

3 current symptoms

2 current symptoms

Unknown/missing

Number of participants with current symptoms

Demographic and baseline characteristics were assessed in the Full Analysis Set.

This was an observational study and the quality of data has not been verified 100%. Baseline data were checked during on-site visits for all patients enrolled in Europe. Due to the COVID-19 pandemic, the planned on-site monitoring visits in the US could not be performed. Instead, more frequent and detailed remote visits were performed for these sites. Follow-up data for all patients were regularly monitored remotely. A certain amount of incorrect/incomplete data has to be assumed for all sites.

Contact for Clinical Trial Information

Any prior or concomitant therapies for managing TGCT-related symptoms

Any changes to concomitant therapies for managing TGCT-related symptoms since the last visit

Any changes to TGCT treatment (including also planned treatments) since the last visit

All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.

Baseline

Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.

Within 1st Year

Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.

Within 2nd Year

Management plans were assessed in participants with available data in the Full Analysis Set. Participants may have be included in more than one category.

Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT)

Wait and see

Currently being treated or planned to be treated

Unknown/Missing

The current treatment plan (currently being treated or planned) was assessed in participants with no changes at any data collection point where the data of the previous reported data collection point is being reported in the Full Analysis Set.

Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT)

Radiotherapy

90Yttrium therapy

Systemic therapy

Surgery

Future surgery required

No current or planned treatment

Unchanged therapy

Type of treatment plans were assessed in participants with available data in the Full Analysis Set. Participants may have be included in more than one category.

Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)

Planned

Current

Status of treatment plan was assessed in participants currently being treated or planned to be treated in the Full Analysis Set. Participants with different reported treatment plans during the period (e.g. participants who may have switched treatment plans) are counted as 'currently being treated or planned to be treated' in the corresponding period.

Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)

Status of treatment plan was assessed in participants currently being treated in the Full Analysis Set. Participants may have been included in more than one category.

Number of Participants Based on Type of Current TGCT Treatment in Patients With Diffuse TGCT (d-TGCT)

Moderate diffuse

Severe diffuse

Not assessable

Tumor severity was assessed in participants in the Full Analysis Set.

Number of Participants Based on Tumor Severity Classification at Baseline Based on MRI in Patients With Diffuse TGCT (d-TGCT)

Complications were assessed among participants with documented surgeries.

Number of Cases With Complications Due to Surgery in Patients With Diffuse TGCT (d-TGCT)

1 recurrence

2 recurrences

Tumor recurrence was assessed in participants with available baseline data in the Full Analysis Set.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Record in an Observational Manner the Treatment of Multiple Myeloma as it is Being Done in Every Day Practice Without Providing Any Investigational Drug or Prescribing Any Procedure	NCT01241396	Multiple Myelom...	Any MMY treatme...	18 Years - 99 Years	Janssen Pharmaceutica N.V., Belgium
Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab	NCT01706120	Ovarian Cancer	Bevacizumab Paclitaxel Carboplatin	18 Years -	National Cancer Institute, Naples
Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project	NCT02948088	Giant Cell Tumo...		18 Years -	Daiichi Sankyo
A Study to Record in an Observational Manner the Treatment of Multiple Myeloma as it is Being Done in Every Day Practice Without Providing Any Investigational Drug or Prescribing Any Procedure	NCT01241396	Multiple Myelom...	Any MMY treatme...	18 Years - 99 Years	Janssen Pharmaceutica N.V., Belgium

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