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NEW TRIALS: HOW TO FIND THEM

Clinical trials offer patients access to promising new treatments which have not yet been approved. They offer an opportunity to help make new treatments available to all patients by helping to advance science. Patients in clinical trials receive high-quality care and are carefully followed.

Click to view and/or download the slides for Step 10.

If commercially available drugs are not working, then new drugs available only within clinical trials may be recommended. Depending upon the circumstances, a patient may also seek to participate in a later phase clinical trial (e.g., phase III) even from the onset of the disease.

ASH 2011 presentations that address STEP 10

REFERENCES

The IMF is pleased to offer a number of ways to help you locate a clinical trial which may be appropriate.

DRUGS & PROCEDURES IN CLINICAL TRIALS
CLINICAL TRIAL FACILITIES AND COOPERATIVE GROUPS
SEARCH TOOLS
CLINICAL TRIALS INFORMATION
Before new drugs or procedures can be approved for use in treating myeloma, they must go through clinical trials to prove that they are safe and more effective than currently-available treatments
MYELOMA MATRIX
Drugs In Development or Recently Approved
The Myeloma Matrix lists drugs currently under development and tracks them from discovery to approval.
Denosumab
Denosumab is a fully human monoclonal antibody against RANK ligand, a protein critical for osteoclast formation, maturation, and function. It is approved for the prevention of skeletal related events in patients with bone metastases from solid tumors, but its effects in patients with multiple myeloma need to be further studied. Currently, a clinical trial of denosumab to help determine if it can prevent skeletal related events in multiple myeloma is under way.

KYPROLIS® (carfilzomib)
Kyprolis ® (carfilzomib)is a next-generation proteasome inhibitor. It is FDA-approved for the treatment of patients with multiple myeloma (MM) who have received at least two prior therapies, including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of the completion of the last therapy.
POMALYST® (pomalidomide) capsules
Like lenalidomide, Pomalyst® (pomalidomide) capsules is an immunomodulatory derivative (IMiD®) of thalidomide. Approved on February 8, 2013, it is well-tolerated in patients who have relapsed after multiple prior therapies and are refractory to both lenalidomide and bortezomib.

REVLIMID®
REVLIMID®, a potent immunomodulatory derivative (IMiD) of thalidomide, induces apoptosis in resistant MM cell lines and patient cells and, more importantly, decreases binding of MM cells to bone marrow stromal cells.
VELCADE®
The latest on VELCADE®—general information, clinical trials, webcasts, publications—is available on the VELCADE® Resource Page.

Elotuzumab (HuLuc63)
Elotuzumab is a monoclonal antibody that targets CS1, a cell surface glycoprotein highly expressed on myeloma cells but minimally expressed on normal cells.
THALOMID® (thalidomide)
Thalidomide was prescribed to lessen the symptoms of morning sickness during the 1950s. It was taken off the market in 1961, when it was found to be a cause of birth defects. Today thalidomide is used in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma.

Mozobil
Mozobil (plerixafor injection) is approved by the United States Food and Drug Administration (FDA) to be used with another agent, granulocyte-colony stimulating factor (G-CSF), to mobilize hematopoietic stem cells into the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM).
Randomized Phase III Study Comparing Conventional-Dose Treatment Using a Combination of Lenalidomide (Revlimid®), Bortezomib (Velcade®), and Dexamethasone (RVD) to High-Dose Treatment with Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age

This study, sponsored by Dr. Paul Richardson of the Dana-Farber Cancer Institute, was designed to answer a very important question in myeloma: In the era of novel drugs, is high-dose therapy (HDT) still necessary in the initial management of multiple myeloma in younger patients? In this study, the addition of HDT to conventional dose treatment (RVD) as compared to conventional-dose treatment (RVD) alone would be considered superior if it significantly prolongs progression-free survival by at least 9 months.


VORINOSTAT (Zolinza® SAHA, MK0683)
Vorinostat is an HDAC inhibitor, which has shown promise in the treatment of multiple myeloma.
ExAblate (MRI-guided Focused Ultrasound Surgery)
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who Are Not Candidates for Radiation