When is a further clinical trial justified

They are also sometimes known as post-marketing studies. What happens in a clinical trial Before the trial All clinical trials have different sets of eligibility criteria for participation. These criteria are usually defined by: Age Gender Illness type and stage Treatment history Other medical conditions The study team will check the health of the participant and screen the participant based on the eligibility criteria outlined in the research plan or protocol.

During the trial Depending on the trial, you may be distributed into different treatment groups. Benefits of participation Aside from phase 1 clinical trials, studies are usually conducted on research treatments that have: Shown to present some level of desirable effects Previous results to suggest continuing its development Hence there is generally a tendency for the trials to show positive results although failures due to lack of benefits or increased risks do occur late in the product development in large phase 3 studies.

Possible risks While clinical trials are designed to minimise the risks to all participants, but may still be demanding and time consuming. Informed consent You must sign an informed consent document before participating in a clinical trial.

Answers to the questions are provided in the informed consent document: What is the purpose of the clinical trial? What are the study procedures required to be conducted in this clinical trial? What is considered as standard care and experimental in this clinical trial?

Who will be responsible for medical care of the participant in this clinical trial? Will the participant be able to continue consulting his healthcare provider? Who should the participant contact in the event of any adverse events? What are the possible risks of participating in this clinical trial? What are the possible benefits of participating in this clinical trial?

Would the participant be required to practice contraception during the clinical trial? What are the alternatives to participation? What are the costs incurred to the participant by participating in the clinical trial? What expenses incurred by the participant are covered by the clinical trial? Can the participant stop participating in the clinical trial at any time?

Will there be compensation for research related injury? Would the participant have access to the study treatment after completion of the clinical trial? Who can the participant contact for any questions about the clinical trial? Rights of participants As a participant in a clinical trial, you have the right to: Be informed about the clinical trial including the objective, study procedures, risks, benefits, compensation and alternative treatments.

Ask questions about the clinical trial. Make an informed decision to participate in a clinical trial without force, fraud, deceit, coercion, duress or undue influence. Withdraw from a clinical trial at any time without compromise of medical care.

Responsibilities of participants You should undergo all the study procedures outlined in the informed consent form and follow the advice given by the study team. Last updated: 31 Dec Clinical trials that are usually conducted on a small number of healthy volunteers with close safety monitoring.

Clinical trials that are conducted on a small number of patients with the illness being researched upon. Clinical trials that are conducted on a larger population of patients. Part 1: Time to final hospital discharge [ Time Frame: Up to Day 28 ] Time from dosing to when a participant is discharged from the hospital.

Part 2: Time to first discharge from investigator site [ Time Frame: Up to day 60 ] Time from dosing to when a participant is first discharged from the investigator site. Part 2: Time to first discharge to non-hospitalized residence [ Time Frame: Up to day 60 ] Time from dosing to when a participant is first discharged to a non-hospitalized residence.

Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : September 14, Study Description. The study is being conducted in 2 parts Part 1 and Part 2. Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor GM-CSF antibody that has not previously been tested in participants with severe pulmonary COVID related disease in Part 1.

Participants will be randomized to receive a single intravenous IV infusion of otilimab or placebo, in addition to standard of care. FDA Resources. Arms and Interventions. All participants will receive standard of care as per institutional protocol. Placebo 1 will consist of sterile 0. Participants age 70 years or above will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 2.

Participants age 70 years or above will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 2. Outcome Measures. Primary Outcome Measures : Parts 1 and 2: Proportion of participants alive and free of respiratory failure at Day 28 [ Time Frame: Day 28 ] Proportion of participants alive and free of respiratory failure at Day 28 measured by an 8-point ordinal scale.

Number of deaths due to all causes will be assessed. Proportion of participants alive and free of respiratory failure at Days 7, 14, 42 and 60 measured by an 8-point ordinal scale.

Time to recovery from respiratory failure measured by an 8-point ordinal scale. Proportion of participants alive and independent of supplementary oxygen measured by an 8-point ordinal scale. Time to last dependence on supplementary oxygen measured by an 8-point ordinal scale. Defined as the time from dosing to when the participant is discharged from the ICU.

Time from dosing to when a participant is discharged from the hospital. Physical examination included assessment of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen liver and spleen , lymph nodes, and extremities. An adverse event AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Blood samples were collected at designated timepoints. The NEI-VFQ consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the impact of ocular toxicity on visual function.

The OSDI is a item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Participants who provided signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Male or female, 18 years or older. Participants with histologically or cytologically confirmed diagnosis of MM as defined in IMWG, criteria, and participant has undergone stem cell transplant or is considered transplant ineligible and has failed at least 3 prior lines of anti-myeloma treatments, including an anti-CD38 antibody example [e.

Female participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.

A WOCBP must have a negative highly sensitive serum pregnancy test as required by local regulations within 72 hours before the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

Male participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. For France only: A participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Symptomatic amyloidosis, active 'polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes' POEMS syndrome, active plasma cell leukemia at the time of screening.

Prior allogeneic stem cell transplant. Current corneal epithelial disease except mild punctate keratopathy. Use of an investigational drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.

Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs. Evidence of active mucosal or internal bleeding. Any major surgery within the last four weeks.

Presence of active renal condition infection, requirement for dialysis or any other condition that could affect participant's safety. Participants with isolated proteinuria resulting from MM are eligible. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Malignancies other than disease under study are excluded, except for any other malignancy from which the participant has been disease-free for more than 2 years and, in the opinion of the principal investigators and GlaxoSmithKline Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy MM.

Participants with curatively treated non-melanoma skin cancer may be enrolled. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment. Pregnant or lactating female. Active infection requiring antibiotic, antiviral, or antifungal treatment.

Presence of hepatitis B surface antigen HBsAg , or hepatitis B core antibody HBcAb at screening or within 3 months prior to first dose of study treatment. Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid RNA test result at screening or within 3 months prior to first dose of study treatment. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. More Information. Belantamab mafodotin for relapsed or refractory multiple myeloma DREAMM-2 : a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. Epub Dec Adv Ther. Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: month follow-up from the pivotal DREAMM-2 study. Epub Jul Management of belantamab mafodotin-associated corneal events in patients with relapsed or refractory multiple myeloma RRMM.

Blood Cancer J. Ophthalmol Ther. Erratum in: Ophthalmol Ther. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Multiple Myeloma. Drug: Belantamab mafodotin frozen liquid Drug: Belantamab mafodotin lyophilized powder. Phase 2. Study Type :. Interventional Clinical Trial.

Actual Enrollment :. Actual Study Start Date :. Actual Primary Completion Date :. Estimated Study Completion Date :. Experimental: Participants receiving frozen 2. Philadelphia, Pennsylvania, United States, Schwerin, Mecklenburg-Vorpommern, Germany,