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Smoldering Multiple Myeloma clinical trials

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NCT ID: NCT02269592 Recruiting - Clinical trials for Waldenstrom Macroglobulinemia

Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome

Start date: August 2014
Phase:
Study type: Observational

Blood cancers occur when the molecules that control normal cell growth are damaged. Many of these changes can be detected by directly examining parts of the cancer or cells in blood. Several alterations that occur repeatedly in certain types of blood cancers have already been identified, and these discoveries have led to the development of new drugs that target those alterations. More remain to be discovered. Some of these abnormalities include alterations in genes. Genes are the part of cells that contain the instructions which tell the investigators bodies how to grow and work, and determine physical characteristics such as hair and eye color. Genes are composed of DNA letters that spell out these instructions. Studies of the DNA molecules that make up the genes are called "molecular" analyses. Molecular analyses are ways of reading the DNA letters to identify errors in genes that may contribute to an increased risk of cancer or to the behavior of the cancer cells. Some changes in genes occur only in cancer cells. Others occur in the genes that are passed from parent to child. This research study will examine both kinds of genes. The best way to find these genes is to study large numbers of people. The investigators expect that as many 1000 individuals will enroll in this study. This research study is trying to help doctors and scientists understand why cancer occurs and to develop ways to better treat and prevent it. To participate in this study the participant must have cancer now, had it in the past, or are at risk of developing cancer. The participant will not undergo tests or procedures that are not required as part of their routine clinical care. The investigators will ask the participant to provide an additional sample from tissue that is obtained for their clinical care including blood, bone marrow, or tissue sample. The investigators will also ask for a gentle scrape of the inside of their cheek, mouthwash or a skin sample to obtain their germline DNA

NCT ID: NCT01955395 Completed - Clinical trials for Smoldering Multiple Myeloma

Genomic and Psychosocial Effects of the 3RP on Patients With MGUS and Smoldering Multiple Myeloma

Start date: October 2013
Phase: N/A
Study type: Interventional

This research study is evaluating the effects of a mind body medicine intervention called the Relaxation Response Resiliency Program (3RP) on stress and stress related symptoms in patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). This research study is a supportive care trial. This means that the intervention program may improve general well-being and comfort, but is not considered a treatment or "cure" for MGUS or SMM. It is considered an investigational intervention because the investigators are examining the effectiveness of a new program - the 3RP - on reducing stress and stress-related symptoms in patients with MGUS and SMM. Standard management of MGUS and SMM involves regular monitoring without chemotherapy. Mind-body medicine, as defined by the National Institutes of Health, "focuses on the interactions among the brain, mind, body, and behavior, and on the powerful ways in which emotional, mental, social, spiritual, and behavioral factors can directly affect health." The 3RP is a newly designed group therapy program that through a variety of mind body principles and self-care interventions seeks to buffer stress and promote psychological resiliency and physical well-being. This study will examine the effectiveness of the 3RP in reducing stress and symptoms associated with stress in patients diagnosed with MGUS or SMM. Data from this study will also be used to assess changes in gene expression that result from 3RP intervention, particularly genetic pathways that are known to be dysregulated in MM.

NCT ID: NCT01838369 Terminated - Clinical trials for Smoldering Multiple Myeloma

A Phase II Study of BI-505 in Smoldering Multiple Myeloma

Start date: March 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.

NCT ID: NCT01718899 Completed - Clinical trials for Smoldering Multiple Myeloma

Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma

Start date: November 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of PVX-410, (a cancer vaccine), treatment regimen for patients with smoldering multiple myeloma as a single agent and in combination with lenalidomide.

NCT ID: NCT01660997 Withdrawn - Multiple Myeloma Clinical Trials

MLN9708 and Dexamethasone for High-Risk Smoldering Multiple Myeloma

Start date: July 30, 2012
Phase: Phase 2
Study type: Interventional

Background: - Smoldering multiple myeloma (SMM) is a condition that can lead to multiple myeloma, a type of blood cancer. In many high-risk cases, SMM can develop into multiple myeloma in less than 2 years. The current standard of care for SMM is follow-up without treatment until multiple myeloma develops. However, some drugs are being studied to see if they can slow down or prevent the disease from progressing. One such drug is MLN9708. It has shown some results against multiple myeloma. Researchers want to combine MLN9708 with dexamethasone to see how it works against high-risk SMM. Objectives: - To see if MLN9708 with dexamethasone is a safe and effective treatment for high-risk smoldering multiple myeloma. Eligibility: - Individuals at least 18 years of age who have high-risk smoldering multiple myeloma. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and a bone marrow biopsy may also be performed. - Participants will take MLN9708 and dexamethasone on a regular schedule for 28 days. They will take each drug four times at regular intervals during each cycle of treatment. - Treatment will be monitored with frequent blood tests and imaging studies. - Participants will have 12 cycles of treatment. After four cycles, patients will be recommended to have their own stem cells collected and stored. This will allow the potential application of a highdose melpahalan/autologous stem cell transplant in the event there is a need in the future (not part of this study). - After 12 cycles, participants will keep taking MLN9708 as long as the disease does not progress and the side effects are not too severe.

NCT ID: NCT01572480 Active, not recruiting - Multiple Myeloma Clinical Trials

Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma

Start date: May 29, 2012
Phase: Phase 2
Study type: Interventional

Background: - Multiple myeloma is a blood cancer that affects the plasma cells. These cells help produce antibodies and fight infection. Smoldering multiple myeloma (SMM) is a related condition that may develop into multiple myeloma. The current standard of care for SMM is close follow-up without treatment until multiple myeloma develops. However, researchers are studying possible treatments for SMM itself. One possible treatment involves a combination of cancer treatment drugs. - Lenalidomide is a drug that may help reduce or prevent the growth of cancer cells. Dexamethasone is a steroid that is often given with other anti-cancer drugs. These two drugs are an approved treatment for multiple myeloma that has not responded to at least one other treatment. Carfilzomib is an experimental drug that has been effective in treating multiple myeloma. Researchers want to combine these three drugs to see if they are a safe and effective treatment for SMM. Objectives: - To see if carfilzomib, lenalidomide, and dexamethasone are a safe and effective treatment for smoldering multiple myeloma. Eligibility: - Individuals at least 18 years of age who have SMM that is likely to progress to multiple myeloma. Design: - Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and baseline bone marrow scans. Bone marrow samples will also be collected. - Participants will have eight 28-day cycles of treatment with the three study drugs. The drugs will be given as tablets or as infusions. Treatment will be monitored with frequent blood tests and study visits. - After the first four cycles, participants who are eligible for a stem cell transplant will have their stem cells collected and stored for future use. - At the end of eight cycles, participants whose disease has not progressed will have up to 12 more cycles of treatment with lenalidomide tablets alone.

NCT ID: NCT01571726 Withdrawn - Multiple Myeloma Clinical Trials

Imaging Studies and the Development of Multiple Myeloma

Start date: March 27, 2012
Phase: Phase 2
Study type: Interventional

Background: - Multiple myeloma (MM) is a type of malignant blood cancer. It affects the plasma cells, which help produce antibodies and fight infection. MM is nearly always preceded by a pre-malignant state, monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). Currently, it is not possible to predict when someone with MGUS or SMM will develop MM. Also, the disease changes in those early states are not well understood. Researchers want to look at imaging studies of people with MGUS, SMM, and MM. They will study whether the growth of blood vessels can be used to predict disease progression. Objectives: - To use imaging studies to evaluate disease progression in multiple myeloma. Eligibility: - Individuals at least 18 years of age who have MGUS, SMM, or newly diagnosed MM. Design: - Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and provide bone marrow samples. - Participants will have positron emission tomography (PET) scans with the new contrast agent [18]F-Fluciclatide. The contrast agent is intended to show patterns of increased vessel growth in the bone marrow. - Participants will also have a magnetic resonance imaging (MRI) scan. This scan will be done according to standard procedures. - Researchers will compare these scans with blood tests and other clinical information to study disease progression of MGUS, SMM, and MM.

NCT ID: NCT01484275 Completed - Clinical trials for High-risk Smoldering Multiple Myeloma

A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma

Start date: March 1, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in patients with high-risk smoldering multiple myeloma (SMM).

NCT ID: NCT01441973 Completed - Clinical trials for Smoldering Multiple Myeloma

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

Start date: December 28, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether elotuzumab will improve response in patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the health of the body's immune system)

NCT ID: NCT01302886 Completed - Clinical trials for Smoldering Multiple Myeloma

Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

Start date: May 2011
Phase: Phase 2
Study type: Interventional

This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.