Our large patient volume supports a program of clinical studies that enable patients to benefit from innovative, cutting-edge care for improved outcomes.

About Clinical Studies                                            

Participating in a Clinical Study                      

Clinical Trials at the Myeloma Institute

About Clinical Studies

Clinical studies are research studies in which people volunteer to help doctors find ways to improve the health of patients so that they can live longer, healthier lives.   Each study tries to answer scientific questions and find better ways to prevent, diagnose, or treat conditions. 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

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.

Clinical Trials at the Myeloma Institute

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

The Myeloma Institute was the first center to achieve truly curative outcomes through its novel Total Therapy approach, characterized by incorporation of proven agents up front for an all-out attack on myeloma. Total Therapy encompasses a series of clinical trials designed by and conducted only at the Myeloma Institute.  Total Therapy has evolved over more than 20 years as patient outcomes have been analyzed, new agents have become available, and molecular nuances of myeloma biology have been identified.  With advanced knowledge, improved diagnostics and new therapeutic agents, we are now taking Total Therapy to the next level with a focus on personalized medicine.

Researchers and physicians at the Myeloma Institute never cease in their commitment in developing new ways to treat myeloma.  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, and partners with SWOG (a cancer research cooperative group) in order to give patients access to some of the latest pharmaceutical advances and to improve outcomes and quality of life.

Clinical trials currently open to patient enrollment at the Myeloma Institute can be found under the headings below.

Newly Diagnosed Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
Previously Treated Multiple Myeloma
Asymptomatic Multiple Myeloma