Multiple Myeloma

Clinical Trials

Below is a list of Multiple Myeloma clinical trials from the clinical trials database at Mayo Clinic.

This list includes only trials about which Mayo researchers choose to publish information. Mayo Clinic may be conducting other trials which are not in this database. Mayo's clinical trials include experimental treatments, often unavailable elsewhere, which frequently lead to improved patient care for people worldwide. Patients should ask their doctor at Mayo about clinical trials appropriate for their situation.

CNTO 328, A Phase 2 Multicenter Study of CNTO 328 (Anti IL- 6 Monoclonal Antibody) in Patients with Relapsed or Refractory (resistant) Multiple Myeloma
Patients are being asked to take part in this research study because the research staff want to find out what effects (good and bad) the CNTO 328 has on the patient and their multiple myeloma. CNTO 328 is a chimeric (murine-human) IgG1 kappa monoclonal antibody against IL-6. IL-6 is a central growth factor for myeloma cells. IL-6 is known to enhance cell growth (proliferation), differentiation, and survival of malignant plasma cells in multiple myeloma. The researchers hope that CNTO 328 will result in inhibition (inability of the cells to grow) of myeloma cell growth and apoptosis (cell death) of myeloma cells resulting in a clinical response (decrease in the level of M-protein). The researchers hope that this treatment option will have less side effects (be less toxic) and utilize the beneficial effects of an anti-IL-6 mAb in combination with dexamethasone for patients with advanced multiple myeloma.
Read more

MC0686, A Phase II Trial of Cyclophosphamide (Cytoxan), Bortezomib (Velcade, PS-341), and Dexamethasone (CYBOR-D) in Patients with Newly Diagnosed Active Multiple Myeloma
This study is being done to find out what good and bad effects the Bortezomib, dexamethasone and cyclophosphamide drugs have on the patient and their multiple myeloma.
Read more

A Phase 2 Study of Carfilzomib in Patients with Relapsed and Refractory (Resistant) Multiple Myeloma
Patients are being asked to take part in this research study because they have a cancer of the blood called multiple myeloma.
The purpose of this study is to see how safe and effective an investigational new drug (a
drug that has not received approval by the U.S. Food and Drug Administration (FDA)) called carfilzomib is in patients with multiple myeloma who have previously received bortezomib and either thalidomide or lenalidomide. The research staff want to find out what effects, good and/or bad, it has on the patient and their cancer.
Carfilzomib is a type of drug called a proteasome inhibitor. A proteasome is a protein found within cells that has the important role of identifying and marking damaged proteins that are needed to be destroyed by the cell for survival. The inhibition of the proteasome allows for damaged protein to build up within cells. This build up of damaged protein causes the cell to die. In the laboratory, the way carfilzomib works is similar to another drug that has been approved by the FDA to treat Multiple Myeloma.
Read more

A Phase 2, Study of Carfilzomib in Patients with Relapsed Multiple Myeloma
Patients are being asked to take part in this research study because they have a cancer of the blood called multiple myeloma.
The purpose of this study is to see how safe and effective an investigational new drug [a drug that has not received approval by the U.S. Food and Drug Administration (FDA)] called carfilzomib is in patients with multiple myeloma who have received prior treatment for their disease. The research staff want to find out what effects, good and/or bad, it has on the patient and their cancer.
Carfilzomib is a type of drug called a proteasome inhibitor. A proteasome is a protein found within cells that has the important role of identifying and marking damaged proteins that are needed to be destroyed by the cell for survival. The inhibition of the proteasome allows for damaged protein to build up within cells. This build up of damaged protein causes the cell to die. In the laboratory, the way carfilzomib works is similar to another drug that has been approved by the FDA to treat Multiple Myeloma.
Read more

A Phase I/II Study of the Raf Kinase/VEGFR Inhibitor Sorafenib (Bay 43-9006) in Combination with the mTOR Inhibitor RAD001 (Everolimus, Certican) in Patients with Relapsed Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Multiple Myeloma
Sorafenib and RAD001 are two drugs that block some of the main switch pathways in tumor cells from working properly. When combined, it is hoped that they might prevent the cells from growing or cause them to die. Preliminary experiments with RAD001 in lymphoma patients have shown definite anti-tumor activity.
Read more

A Phase II Trial of CC-4047 (Actimed) Plus Dexamethasone (Decadron) in Patients with Relapsed or Refractory (Resistant) Multiple Myeloma
Patients are being asked to take part in this research study because they have multiple myeloma that has recurred after initial treatment. CC-4047 is a new drug that is related to thalidomide and lenalidomide. The research staff is studying the effects, both good and bad, of CC-4047 in combination with dexamethasone in patients with multiple myeloma that has recurred after initial treatment.
Read more

A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma
Sunitinib is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in treatment of multiple myeloma. In patients with this type of cancer there are increased numbers of blood vessels in a patient's bone marrow associated with the cancer cells. Sunitinib is known to be able to decrease the blood vessel formation in tumors and thus may be able to benefit patients. In addition, it is also known to decrease the effect of certain chemical substances secreted by the cancer cells that are known to be important for survival of the cancer cells. This is the reason we are studying the potential benefits of this drug.
Read more

ACF4375g: An Open-Label, Phase 1b, Dose-Escalation Study of the Safety and Pharmacology of the Anti-CD40 Monoclonal Antibody SGN-40 Administered in Combination with Bortezomib (Velcade, PS-341) in Patients with Relapsed or Refractory (resistant) Multiple Myeloma
Patients are being asked to take part in this research study because they have a type of cancer called multiple myeloma that has reoccurred after initially responding to treatment or they have failed to respond to a previous treatment. The purpose of this study is to test the safety of SGN-40 at different dose levels when combined with a drug called bortezomib (Velcade). The research staff want to find out what effects, good and/or bad, it has on patients and their multiple myeloma. It will also determine the highest tolerated dose of SGN-40 that may be used in other studies.




The use of SGN-40 in this research study is experimental which means that it is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. Bortezomib is approved by the FDA for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Read more

C05008, Phase 1/2 Study of Velcade (Bortezomib, PS-341), Dexamethasone, and Revlimid (Lenalidomide) (VDR) versus Velcade, Dexamethasone, Cyclophosphamide (Cytoxan), and Revlimid (VDCR) versus VELCADE, Dexamethasone, and Cyclophosphamide (VDC) in Patients with Previously Untreated Multiple Myeloma
Patients are being asked to take part in this research study because they have multiple myeloma. The purpose of this study is to learn if combining three or four specific drugs in patients who have this type of cancer is safe and effective. The drugs being studied are Velcade, dexamethasone, cyclophosphamide, and Revlimid. Velcade (bortezomib) has been approved by the U.S. Food and Drug Administration (FDA) for use in the treatment of multiple myeloma in patients who have received at least one prior anti-cancer therapy.
Revlimid (lenalidomide) has been approved by the FDA for use in combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least one prior anti-cancer therapy. Cyclophosphamide has been approved by the FDA for use in multiple myeloma.

Revlimid and Velcade are new types of agents that work in different ways than ordinary chemotherapy. In this study the researchers are combining these new drugs along with some of the older drugs like cyclophosphamide and dexamethasone to try to improve the treatment for multiple myeloma. Multiple Myeloma cells respond to signals that can turn on the growth of the cells or make them divide. Revlimid and Velcade are two drugs that block some of the main pathways in the tumor cells from working properly and cyclophosphamide and dexamethasone cause myeloma cells to die. It is hoped that the combination will be more effective in preventing the cells from growing or cause them to die.

This study will also determine the highest safe dose of cyclophosphamide that can be given in combination with Velcade, dexamethasone, and Revlimid; how the patient's cancer responds to treatment, how long it takes the patient's cancer to respond, how long their cancer continues to respond, and how long the patient's cancer maintains a response when they are no longer taking the study drugs.

This study will be conducted in two parts. Part 1 of this study will determine the safest amount of the drug cyclophosphamide that can be combined with other drugs Velcade, dexamethasone and Revlimid. All patients enrolled in Part 1 will receive Velcade, dexamethasone and Revlimid in the same amount (dose), but the dose of cyclophosphamide that the patient will receive may be different than other patients. Once the highest safe dose of cyclophosphamide is determined in Part 1, then Part 2 of the study will begin.

In Part 2 of the study, patients will be assigned randomly (like flipping a coin) to one of three possible drug combinations. Patients will receive either:
-A combination of Velcade, Dexamethasone, and Revlimid, also called "VDR", or
-A combination of Velcade, Dexamethasone, and Cyclophosphamide, also called "VDC", or
-A combination of Velcade, Dexamethasone, Cyclophosphamide, and Revlimid, also called "VDCR".

The research staff will determine if the patient's cancer responds to these experimental drug combinations by measuring the cancer-related proteins (M-protein) in the patient's blood and urine. In addition to the traditional ways to measure myeloma, this study will also be using a more sensitive test called "immunophenotyping via flow cytometry". This test can detect very low numbers of myeloma cells in the patient?s bone marrow that can help researchers better understand the state of the patient's cancer. This test may require the collection of additional bone marrow samples at screening.
Read more

Comparison of Peripheral Blood Stem Cell Transplantation with Bone Marrow Transplantation for the Treatment of Serious Hematological Malignancies
This research study will compare the outcomes of study participants who have had peripheral blood stem cell transplantation from unrelated donors with those who have had bone marrow transplant from unrelated donors for the treatment of serious hematological malignancies.

Two types of stem cell transplantation have been used to treat patients with certain types of serious diseases. Stem cells can be obtained from bone marrow or from circulating blood (peripheral blood stem cells). Participants may be treated with a transplant of either bone marrow or peripheral blood stem cells (PBSC) from unrelated donors.

Both of these types of transplant have been successful for the treatment of leukemia and myelodysplasia. The goal of this research study is to see if there are better results using a bone marrow transplant or a PBSC transplant from unrelated donors.
Read more

COX 2 Inhibitor (Celecoxib) for the Treatment of MGUS and Smoldering Myeloma (CN-25140)
This study is being done to find out what effects (good and bad) the drug Celecoxib (a nonsteroid anti-inflammatory drug) has on a patient and the patient's MGUS or Smoldering Myeloma.
Read more

E1A05, Randomized Phase III Trial of Consolidation Therapy with Bortezomib (Velcade®)-Lenalidomide (Revlimid®) -Dexamethasone (VRD) versus Bortezomib (Velcade®) - Dexamethasone (VD) for Patients with Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen
Patients are being asked to take part in this research study because they have a type of cancer called Multiple Myeloma. The purpose of this study is to find out what effects (good and bad) the two combinations of drugs have on the patient and their multiple myeloma. In this study patients will get either bortezomib, lenalidomide and dexamethasone, or bortezomib and dexamethasone. Patients will not get both treatments.
Lenalidomide (CC-5013) and bortezomib are approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma in patients who have failed at least one prior therapy; lenalidomide has also been approved for the treatment of a rare bone marrow disorder called 5q-myelodysplastic syndrome. The experimental treatment in this study is to test novel agent combinations as an alternative to stem cell transplantation. The use of bortezomib, lenalidomide and dexamethasone in this stage of myeloma is also considered experimental. Both lenalidomide and bortezomib target myeloma cells directly and cause these cells to die. In addition, both drugs are also felt to interfere with the ability of the bone marrow environment to support the growth of myeloma cells. In this study, in one of the two arms, the two drugs are being combined with a goal of improving the response to therapy.
Read more

Systemic Administration of (Edmonston Strain) of Measles Virus, Genetically Engineered to Express NIS, with or without Cyclophosphamide in Patients with Recurrent or Refractory Multiple Myeloma (MC038C)
Researchers are trying to find new treatments that may be more effective at treating multiple myeloma. The "drug" used in this trial is a modified version of the measles virus used to vaccinate children. The virus has been altered by having an extra gene (piece of DNA) added for a protein called NIS inserted into it. NIS is normally found in the thyroid gland (a small gland in the neck) and helps the body concentrate iodine. Having this additional gene will make it possible to track where the virus goes in a patient's body.

Both the unmodified measles vaccination virus (MV-Edm) and this modified virus (MV-NIS) have been shown to multiply in and destroy myeloma cells in the test tube and in research mice. Researchers hope the MV-NIS will have the same effect in myeloma cells in patients. Because most people have either had the measles or had a measles vaccination, the patient's body may rapidly destroy the MV-NIS. This will be monitored by blood, urine, mouth rinsing, and imaging tests. It is for this reason, however, that some patients may receive in addition to the MV-NIS, a drug called cyclophosphamide. Cyclophosphamide is a common chemotherapy drug which also suppresses the immune system. If researchers find that patients rapidly destroy the MV-NIS, future patients will receive a low dose of cyclophosphamide before the MV-NIS injection to reduce the ability of the patient's immune system to quickly destroy the MV-NIS. Patients will be informed if they will be receiving MV-NIS alone or MV-NIS and the cyclophosphamide.

This virus has not been tested in humans before and it is not a vaccine.

This study is being done to:

-Test the safety of the administration through a vein (IV) of MV-NIS (with or without cyclophosphamide)
-Determine the maximum dose of the virus that can be safely administered in patients with myeloma (with and without cyclophosphamide)
-Determine the fate (where it is, how long it stays there, how it multiplies) of the virus in the body using I-123 with gamma camera imaging. These small doses of radioactive isotope (iodine-123) are used routinely to image the thyroid and other organs without any known problems
-Evaluate the effects of the virus on the body using blood, throat swabs, urine samples and bone marrow biopsies
-Evaluate whether this investigational virus can have any impact on the amount of disease present in patients
Read more

Zevalin Radionimmunotherapy with High-Dose Melphalan and Stem Cell Transplant for Multiple Myeloma (MC048A)
This research study is being done to:

• Test the safety of an antibody (a protein generated by immune system) called rituximab and a radioactive antibody called Yttrium-90 Zevalin when they are given together with standard high-dose melphalan chemotherapy and stem cell transplant
• See what effects (good and bad) this combination therapy has on you and your multiple myeloma
• Learn what effect this treatment has on your blood B lymphocytes after transplant
• See what effects the radioactive antibody (Yttrium-90 Zevalin) has on your myeloma cells.

Zoledronate with or without Thalidomide for Early Stage Multiple Myeloma (MC0289)
This study is being done to learn the effects (good and bad) of thalidomide and zoledronic acid on multiple myeloma.
Read more