“I’m starting a new treatment next week,” wrote a member of MyMyelomaTeam. “I’m hoping for good results!” If you or a loved one is living with relapsed or refractory multiple myeloma, you understand the hope for safe and effective new treatments that can help you feel better and live longer.
Clinical trials are essential for the development of new treatments, and they rely on the participation of people living with myeloma. These studies offer the only way to better understand the disease and how new treatment options might help improve quality of life and overall survival. Twenty-eight members of MyMyelomaTeam report having been part of a clinical trial.
Research teams developing drugs for multiple myeloma, leukemia, lymphoma, and other blood cancers need to study the effectiveness of new treatments before they’re made available for general use. Clinical trials for myeloma are studying therapies that can use the immune system to fight cancer and slow the development of cancerous plasma cells in bone marrow.
Read on to learn the basics about how clinical trials work and some of the potential benefits and risks to consider.
If laboratory research indicates a new drug therapy for multiple myeloma seems safe, researchers will design a clinical trial, which is a study with human participants. Clinical trials determine if a new treatment is safe and effective before it’s made available to the public. Clinical research also continues to monitor long-term effects after the drug receives FDA approval. Some clinical trials don’t test new drugs at all and instead evaluate new ways to improve cancer prevention, overall health, or survivorship.
Clinical trial plans are carefully reviewed and regulated to protect the health and privacy of people who volunteer as participants. Every country has structures for reviewing and approving clinical trial protocols. In the United States, the protocols for a clinical study must be reviewed by an ethics committee, called an institutional review board, and approved by the FDA before the clinical trial can begin.
If serious safety concerns, such as dangerous side effects, occur during a clinical trial, the study will be stopped.
Each clinical trial has eligibility criteria to determine who is appropriate to participate and factors that might exclude someone. Age, stage of disease, prior therapies, and medical history are some of the criteria that may affect whether someone is eligible for a multiple myeloma clinical study.
Participating in clinical research is completely voluntary. Research teams are required to provide people with the following:
This process is called informed consent. In addition, any participant in a clinical trial has the right to leave a study at any time, for any reason.
There are many reasons a clinical study may be worthwhile to consider if you’re living with multiple myeloma. Here are some potential benefits of joining a clinical trial.
When you participate in an oncology clinical trial, you may gain access to cancer treatments that are in development, new combinations of treatments, or existing treatments under review for new types of use.
The treatment being studied is called an investigational drug or therapy. Every existing treatment has gone through a clinical trial, giving some participants early access to new therapies. Drugs that are now standard care treatments for multiple myeloma — such as dexamethasone, lenalidomide (Revlimid), and carfilzomib (Kyprolis) — all went through clinical trials.
A new drug therapy for multiple myeloma may be safer and more effective than standard treatment. Novel treatments may also help more people achieve remission (when symptoms decrease or disappear), maintain remission longer, or provide a new treatment option for people with relapsed or refractory multiple myeloma that hasn't responded to other drug therapies.
Clinical trials are typically sponsored by drug companies, government grants, or research foundations. The sponsors of a clinical trial usually pay the research costs for participants, including potential access to a new drug. You may be asked to have your health insurance cover routine costs for your standard multiple myeloma care during a clinical trial.
For people without health insurance, clinical trials can sometimes provide access to treatment that might otherwise be out of reach.
A clinical trial can give you access to researchers who are on the cutting edge of multiple myeloma treatment. A relationship with a cancer research study team may provide useful information on the disease and offer new knowledge on standards of care for people with multiple myeloma.
Furthermore, a clinical trial may include monitoring, care, assessments, and follow-up that provide new perspectives on your needs. Having your condition reviewed by clinicians on a research team may help you better understand unmet needs you could discuss with your health care providers, caregivers, and family members.
During a clinical trial, the research team will work with your health care providers to ensure continuity in your care.
By participating in a clinical trial, you help researchers dedicated to finding new and improved treatments for multiple myeloma. New drug development can’t happen without clinical trials, and volunteers play an essential role in the progress of medical research.
For some people, participation offers a way to help others. Even if a particular clinical trial doesn’t directly help improve your medical care or lead to a new drug, it will provide valuable insights that will ultimately help researchers make new advances in multiple myeloma treatment.
Before you participate in a clinical trial, it’s important to understand potential risks and drawbacks. Here are some of the reasons you might decide not to participate in clinical research.
Although researchers hope clinical trials will result in effective treatments for all participants, there’s no guarantee that a new approach will be more beneficial for you than current therapies. The FDA ultimately approves only about 14 percent of medications in trials.
Every medication has a risk of side effects. Clinical trials are keen on identifying and evaluating side effects, and if you participate, you’ll be monitored for adverse reactions. Researchers will also discuss the risk of side effects with you before you consent to participate.
If serious side effects do occur, the institutional review board (which approved the trial) and a data and safety monitoring board will help decide if the trial should end. This allows an impartial group of people, not just the researchers, to assess participants’ safety during a clinical trial.
Clinical studies take time, and some may require travel. For some people, it may be inconvenient to maintain a schedule that can include extra medical appointments at hospitals or cancer centers, additional medical procedures, and potentially complicated medication regimens. It’s important to discuss these aspects of a clinical trial in detail before you decide to participate.
A placebo is an inert (inactive) substance used in some clinical studies to compare with the investigative drug. Placebos are sometimes referred to as “sugar pills” because they don’t have any medical properties. In some types of studies, one group of participants will receive a placebo instead of the drug that’s being studied.
Clinical studies for cancer may incorporate a placebo in certain situations, especially when existing treatments don't seem to work well or if current treatments aren't effective or cause serious side effects. However, it’s important to know that you’ll continue to receive the standard treatment for your myeloma, even if you receive a placebo instead of the new therapy.
If you participate in a clinical study that uses a placebo, you must be informed that placebos are being used. However, in a double-blind study, neither you nor the researchers will know if you’re receiving a placebo or the new treatment.
In another type of clinical trial, known as a crossover trial, each participant gets the opportunity to experience the experimental drug. This trial is designed so that one group receives an experimental drug, another group gets a placebo, and the groups later switch treatments. This way, researchers can observe the effect of both the experimental drug and placebo in the same people.
Your oncologist can provide you with more information about clinical trials for multiple myeloma and discuss whether clinical research would be right for you. You can find out more about clinical trials now underway for multiple myeloma at clinicaltrials.gov. The Leukemia & Lymphoma Society also provides resources for navigating the clinical trial process and can provide additional information.
MyMyelomaTeam is the social network for people with multiple myeloma and their loved ones. On MyMyelomaTeam, more than 20,000 members come together to ask questions, give advice, and share their stories with others who understand life with myeloma.
Have you participated in a clinical trial for multiple myeloma? Have you discussed this option with your health care provider? Share your experience in the comments below, or start a conversation by posting on your Activities page.