Trial COMMANDS - Myelodysplastic Syndromes (MDS) - ACE536-MDS-002 – Canada

What are clinical trials?

Clinical studies, also called clinical trials, are research studies in which participants are asked to take a study drug under the supervision of a physician and other research professionals. A study drug is a drug that is not yet approved by Health Canada (HC).

Clinical studies must be reviewed by a Research Ethics Board (REB) or Ethics Committee (EC). A REB or EC is a group responsible for helping protect the rights and welfare of study participants. In addition, each participant in the study is monitored with study-related medical tests and examinations before, during, and sometimes even after the study.

Who conducts clinical studies?

In general, governments and sponsor companies (such as pharmaceutical or biotechnology companies) conduct clinical studies. They are responsible for creating a strict study protocol (a written description of a study) and ensuring that everyone involved follows it for the entire duration of the study.

What should I expect?

Prior to participating in a clinical study, you will be provided with a detailed description of the study and the possible risks and benefits in a written “Informed Consent Form”, and it will be discussed with you. You will be asked to review and sign the Informed Consent Form before participating to show that you understand the study and its possible risks and benefits.

If you are eligible, you can be enrolled in the clinical study. Once enrolled, do not hesitate to discuss your research care with the study doctor or study staff members at any time during the course of your participation in the study.

It is important to:
• Attend all scheduled visits
• Follow treatment and follow-up schedules
• Describe your physical state, your feelings and your welfare exactly and honestly to the study doctor
• Discuss any questions about the study with the study doctor

As a participant in the study, you will have the right to contact the representative of the study REB or EC about your rights as a research participant. You will also have the right to leave the study at any time and for any reason.

Can I leave the study if I change my mind?

Participation in any clinical study is entirely voluntary, and participants can withdraw from a clinical study at any time and for any reason, and without any penalty or loss of medical care or benefits to which you are entitled.If you wish to leave the study, you should discuss this with the study doctor, who will provide you with information on how to do so safely and make the necessary arrangements to provide you with additional medical care and follow-up.

What happens when the study is completed?

In general, at the end of a study, researchers analyze the data that were collected from all participants. These results and the collected data will be compared to those of other participants. Anonymized (not personal) data may also be shared with experts and various government agencies responsible for the approval of new drugs, biologic products and devices.

What happens when the study is completed varies from one study to another. In general, participation ends when the study ends, because it might not be safe or effective to continue the study treatment based on what is known at that time. Participants in the clinical trial may withdraw from the study at any time without compromising the rest of their usual medical care.

After the end of the study, participants will generally receive the aggregated study results directly from their study site.

Learn more about study participation

Study participation lasts approximately six years (and may be shorter or longer for some patients). This includes:
• A screening period of approximately 35 days,
• an initial treatment period of 24 weeks (which can be extended if certain criteria are met and if you continue to benefit from treatment), and
• a follow-up period where you will be contacted approximately every 12 weeks to ask how you are doing.

The study drug used in the COMMANDS Trial is a protein that aims to help increase the production of red blood cells in the bone marrow. The study drug will be administered by subcutaneous injection every three weeks during the treatment period.