Clinical Trials

Myeloma

The Myeloma Institute is committed to offering a program of clinical trials to advance novel treatments and diagnostic approaches for patients now and in the future.  Clinical trials link research and patient treatment by evaluating new drugs, diagnostic tools to drive innovation clinical practice.

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Clinical Trial Listings
What is a Clinical Trial?
Participating in a Clinical Trial
Quick Facts about Clinical Trials
What are the Potential Benefits of Participating in a Clinical Trial?
What are the Possible Risks of Participating in a Clinical Trial?
VIDEO:  Optimizing Care Through Clinical Trials—Dr. Faith Davies
VIDEO:  An Expert Explains Why to Consider a Myeloma Clinical Trial—Dr. Faith Davies
VIDEO: Are There Any Maintenance Therapies Currently in Clinical Trials?—Dr. Gareth Morgan

Myeloma Institute Clinical Trials

The Myeloma Institute conducts clinical trials to advance novel treatments and diagnostic approaches for patients with multiple myeloma and related diseases.

At the core of the successful outcomes at the Myeloma Institute is a treatment approach that combines chemotherapy with autologous stem cell transplantation followed by a maintenance strategy. This approach, known as “Total Therapy,” incorporates proven myeloma agents up front to reduce tumor burden during initial treatment to prevent later relapse.

The Myeloma Institute was the first center to achieve truly curative outcomes in multiple myeloma through the novel Total Therapy approach, which encompasses a series of clinical trials designed by and conducted only at the Myeloma Institute.  Total Therapy has evolved over the years to include new agents with novel mechanisms of action, yielding significant improvements in overall survival and progression-free survival.

Researchers and physicians at the Myeloma Institute never cease in their commitment in developing new ways to treat multiple myeloma and other related diseases.  Our Investigators continue to design clinical trials to answer important scientific questions and to find better ways to treat patients and improve outcomes.

The Myeloma Institute also participates in many collaborative, multi-center clinical trials sponsored by pharmaceutical companies in order to give patients access to some of the latest pharmaceutical advances and to improve outcomes and quality of life.

Browse Myeloma Institute clinical trials currently enrolling new patients.

What is a Clinical Trial?

A Clinical trial (or clinical research) is a research study in which people participate as volunteers to help doctors find ways to improve the health of patients so that they can live longer, healthier lives.

Cancer clinical trials test many types of therapies, such as new drugs or new combinations of treatments.  The goal of each study is to answer scientific questions to find better ways to prevent, diagnose, or treat patients with cancer and those who will develop cancer in the future.

All of today’s standard cancer treatments were first shown to be effective in clinical trials. New and better treatments for cancers, such as multiple myeloma, will be discovered only through the continued support of patients who participate in clinical trials.

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veterans Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.

There are two types of clinical studies.

Observational study: This is a type of study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions.

Clinical trial (interventional study): A clinical trial is a study in which participants receive one or more interventions so that researchers can evaluate the effects of the interventions on health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. The FDA (Federal Drug Administration) categorizes clinical trials into phases in order to describe the clinical trial of a drug based on the study’s characteristics, such as the objective and number of participants.

There are five phases of clinical trials (https://clinicaltrials.gov/):

  • Phase 0: Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies).
  • Phase 1 studies emphasize safety. The goal is to find out what the drug’s most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.
  • Phase 2 studies gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
  • Phase 3 studies gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
  • Phase 4 studies occur after the FDA has approved a drug for marketing. These include post-market requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug’s safety, efficacy, or optimal use.

Expanded Access studies are trials in which the FDA allows manufacturers to provide investigational new drugs for patients with serious diseases or conditions who cannot participate in a clinical trial.

Participating in a Clinical Trial

 Taking part in a clinical trial is voluntary.  Not all clinical trials are right for all patients. A trial may be safe for one patient, but not for another. Each trial has strict rules that the healthcare team must follow in order to determine who is eligible to join the clinical trial. These eligibility criteria include information about a patient’s age, gender, medical test results, current and prior treatments and medicines, treatment duration, length of time since previous treatment, and any other health problems or conditions.

Patients must go through a process called informed consent before being enrolled in a clinical trial. This process involves explanation about important information related to the study, including potential risks and benefits and available alternatives, so that potential participants can make an informed decision about whether or not to enroll. Also emphasized during the process of informed consent is that a clinical study is completely voluntary and that participants can withdraw from a study at any time.

Patients are not required to sign the informed consent form immediately. Patients are encouraged to take time to review the form and to ask questions about anything that might not be clear. Patients can also ask questions at any time during the course of the clinical trial. Similarly, any new risks or side effects that become known during the clinical trial will be explained to participants.

Quick Facts about Clinical Trials

Before you decide whether a clinical trial is right for you, make sure you know the facts.

  • Almost every cancer treatment offered to patients today has come about because of a clinical trial.
  • The goals of individual trials vary. They range from looking at new, potentially curative therapies to ones with fewer side effects.
  • The vast majority of trials at the Myeloma Institute do not use a placebo.
  • We encourage patients to ask questions before deciding to participate in a clinical trial. Examples include:
    • What will I have to do if I decide to participate?
    • Will I have to stay in the hospital?
    • Will I have to come to the Myeloma Institute for all treatments and tests? How often?
    • Will I have to change my daily activities or my diet?
    • Who will be in charge of my care?
    • What type of long-term follow-up care is part of this study?
    • If I have questions about the trial, whom can I contact?

What are the Potential Benefits of Participating in a Clinical Trial?

  • You may gain access to new drugs and other treatments, sometimes years before they are widely available.
  • You will be monitored closely for any side effects.
  • You will have the chance to take an active role in your own healthcare.
  • You will be making a valuable contribution to cancer research.

What are the Possible Risks of Participating in a Clinical Trial?

  • A clinical trial can sometimes require more time and medical attention than normal care. This can include doctor visits, phone calls, more treatments, a hospital stay, or a more complicated treatment regimen. Always be sure to ask your doctor for more information about what is required for trial you are considering.
  • The treatment might not work.
  • The treatment might cause serious side effects.
  • Even if a new treatment helps some patients, it might not help you.