Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Smoldering Multiple Myeloma

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Precancerous Conditions

Hypergammaglobulinemia

Selinexor 40mg weekly for up to 12 cycles. Each cycle will be 28 days in length.

Low-dose Selinexor for the Treatment of Intermediate to High-Risk Smoldering Multiple Myeloma

Selinexor

Jodi Lipof

Brea Lipe

Selinexor is a drug that has been approved in the treatment of patients with symptomatic multiple myeloma. The standard of care for patients with Smoldering Multiple Myeloma remains observation, but there are numerous clinical trials investigating interventions to delay progression to multiple myeloma and prevent or delay disease related outcomes. A subset of patients with intermediate or high risk smoldering multiple myeloma have a much higher risk of progressive to multiple myeloma, while the low risk smoldering myeloma patient population has a much lower risk. This is a clinical trial investigating the use of low-dose selinexor in patients with intermediate to high-risk smoldering multiple myeloma. The investigators hypothesize that the use of selinexor in intermediate to high risk smoldering myeloma patients will help to delay progression of disease to symptomatic multiple myeloma.

Plasma cell disorders are a spectrum of diseases ranging from monoclonal gammopathy of undetermined significance (MGUS), to smoldering multiple myeloma (SMM), to multiple myeloma (MM). Multiple myeloma is preceded by an asymptomatic precursor state in the majority of cases. While the vast majority of these patients do not progress to have symptomatic disease, there is an intermediate to high-risk subset of patients with SMM that do go on to meet criteria for MM, including hypercalcemia, anemia, renal insufficiency, and lytic bone lesions.

There are numerous risk stratification systems that have been devised to predict which patients have the highest risk of progression. The Mayo Clinic group identified 3 factors as predictors for early progression. these factors include a bone marrow plasma cell burden of greater than 20%, a monoclonal protein (M-spike) of 2g/dL or greater, and a ratio of involved to uninvolved serum free light chains of 20% or greater. Patients with one more of these risk factors have an increased risk of progression to MM in the first five years after diagnosis.

The current standard of care for the treatment of patients with SMM is observation because numerous early studies failed to demonstrate a survival advantage with pharmacologic intervention. More recent studies have aimed to select out the high-risk patients where intervention is more likely to be beneficial in preventing or delaying progression. The approaches have ranged in intensity and aim, with some approaches aimed at preventing or delaying progression, and others aimed at treating aggressively with curative intent. While the preliminary results of these studies have been promising, there is no consensus on the optimal approach in patients with intermediate to high-risk smoldering multiple myeloma.

Selinexor is a small-molecule selective inhibitor of nuclear export (SINE), which inhibits exportin-1 (XPO1) in a slowly reversible, covalent manner. XPO1 is a transport protein that is responsible for transport of over 200 proteins from the nucleus to the cytoplasm. Inhibition of XPO1 leads to accumulation of tumor suppressor proteins, cell-cycle regulators, and oncoprotein mRNAs in the nucleus and eventually leads to apoptosis of malignant cells. XPO1 inhibition has been shown to induce apoptosis in malignant MM cells and impede osteoclastogenesis without toxicity to surrounding bone marrow stromal cells (BMSCs).

Selinexor has been FDA approved for the treatment of relapsed and refractory multiple myeloma and is currently being studied in the frontline and relapsed settings with different therapeutic combinations in the STOMP trial. Selinexor has not been studied in the precursor disease population. While the exact mechanisms of progression from SMM to MM are incompletely understood, it has been shown that XPO1 expression is increased during progression of disease, which makes this a promising target in this population of patients. The investigators aim to limit the side effect profile while maintaining efficacy of treatment for SMM, with the goal of delaying or preventing progression to MM. The investigators hypothesize that at a low tumor-burden disease, a lower dose of selinexor may be efficacious and lead to an improved toxicity profile than standard dosing.

This is a single-center, open-label, phase 2, single-arm clinical trial of selinexor in patients with intermediate to high-risk smoldering multiple myeloma. Intermediate-risk patients will start enrolling after 5 high-risk smoldering myeloma patients have been enrolled and received 1-2 cycles of treatment. Patients will receive selinexor 40mg orally weekly for up to 12 cycles. Each cycle will be 28 days in length. Patients will receive treatment up to 1 year and continue in follow-up for 2 years after completion of the treatment period.

Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma

Selinexor for the Treatment of Patients With Intermediate and High-Risk Smoldering Multiple Myeloma

The study will assess how long participants will not have the cancer get worse while treated with selinexor

M-spike will be measured in g/dL and sFLC will be measured in mg/dL

The study will assess how long participants will not have the cancer get worse while treated with Selinexor

Karyopharm Therapeutics Inc

University of Rochester

Assistant Professor - Department of Medicine , Hematology/Oncology (SMD)

Nutritional and Metabolic Diseases

Amyloidosis

Immunoglobulin Light-chain Amyloidosis

Monoclonal Gammopathy of Undetermined Significance

Waldenstrom Macroglobulinemia

Proteostasis Deficiencies

Metabolic Diseases

Lymphatic Diseases

AL Amyloidosis

Blood and 3-4 cc bone marrow aspirate collected at same time (in association with treatment protocols on which patient is registered)

biologic sample preservation procedure

Joshua Espstein, DSC

RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer to study in the laboratory may help doctors find better ways to ways to treat the cancer.

PURPOSE: The purpose of this study is to collect and store blood and bone marrow samples from patients with multiple myeloma, smoldering myeloma, Waldenstrom's macroglobulinemia, amyloidosis, and monoclonal gammopathy of undetermined significance to be tested in the laboratory.

OBJECTIVES:

* Maintain and expand tissue repositories of myeloma specimens from uniformly treated Southwest Oncology Group (SWOG) patients with multiple myeloma, smoldering myeloma, Waldenstrom's macroglobulinemia, amyloidosis, or monoclonal gammopathy of undetermined significance.
* Utilize scientific information generated from intergroup and collaborative studies to assist the SWOG Myeloma Committee in the development of new and more effective treatment regimens for these patients.

OUTLINE: Patients receive treatment as directed by the treatment protocols on which they are registered. Specimens of blood and/or marrow are submitted to the Myeloma Repository. The status of the patient (e.g., pre-study, post-remission, or relapse) will be recorded prior to specimen collection.

PROJECTED ACCRUAL: Not specified

S0309, Repository: Blood/Bone Marrow From Pts. With Myeloma, WM, Amyloidosis, or MGUS.

S0309, Myeloma Specimen Repository Protocol, Ancillary

National Cancer Institute (NCI)

SWOG Cancer Research Network

Syndrome

Leukemia

Leukemia, Lymphoid

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphocytic, Chronic, B-Cell

Myeloproliferative Disorders

Preleukemia

Myelodysplastic Syndromes

Disease Progression

Lymphocytosis

Myelodysplastic-Myeloproliferative Diseases

Bone Marrow Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Patients' tumor tissue including bone marrow, blood, buccal swab or mouthwash, lymph node, urine or other specimens will be collected from patients who consent to the protocol

Irene Ghobrial, MD

Joseph Grider

Olga Kozyreva, MD

Saida Hussain

Pedro Sanz-Altamira, MD

Laura Melancon

Michael Constantine, MD

Rebeka Lovato

Kathleen Allen

Mohammad Omaira, MD

Shannon Peabody

Jeanna Walsh, MD

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

The purpose of this research study is to perform these molecular analyses on tissues (obtained from biopsies), blood, or other body fluids such as saliva. Importantly, this study will use tissue specimens that have already been collected as part of a participant's clinical care. The participant's tissue sample may be used to create a living tissue sample (called a "cell line") that can be grown in the laboratory. This allows researchers to have an unlimited supply of cells in the future without asking for more samples.

In this study, analyses will be performed on material only after all necessary clinical tests have been performed. In general, no additional procedures will be required. However, the investigators are asking the participant's permission to obtain one additional sample of blood (a few teaspoons), a gentle swab from the inside of their mouth or a sample of skin to obtain some cells. These are sources of normal, non-cancer cells which are needed for some types of analyses.

To fully understand the effects that molecular alterations have on blood cancers, they must be analyzed in the context of clinical behavior. Therefore, this study also asks the participant's permission to link the molecular alterations in their cancer or leukemia with clinical information that has been generated during the course of their clinical care. No additional clinical tests will be required. The investigator will ask to see the participant for follow up at regular interval to follow their risk of progression.

Some of participant's specimens as well as some of the material generated during the analysis of their tissues or blood may be useful for future study. The Investigator's are asking for the participant's permission to store these specimens and materials in a secure storage facility for possible later use.

Finally, rapid progress in understanding and treating cancer will occur when some of the molecular information derived from tissue and blood can be shared with other researchers. In particular, the National Institutes of Health (NIH) and other organizations have developed special data (information) repositories that analyze data and collect the results of certain types of genetic studies. These central banks will store genetic information and samples and give them to other researchers to do more studies. Therefore, the Investigators are also asking your permission to share your results with these special banks. The participant's information will be sent with only a code number attached. The participant's name or other directly identifiable information will not be given to central banks. There are many safeguards in place to protect the participant's information and samples while stored in repositories and used for research. The investigators do not think that there will be further risks to the participant's privacy and confidentiality by sharing this information with these banks. However, the investigator's cannot predict how genetic information will be used in the future.

Blood, buccal swabs or mouthwashes, and urine

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

Study of Precursor Hematological Malignancies to Assess the Relationship Between Molecular Events of Progression and Clinical Outcome

The Leukemia and Lymphoma Society

Dana-Farber Cancer Institute

Principal Investigator

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Lenalidomide

Dexamethasone acetate

BB 1101

Elotuzumab

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8

Other Name: HuLuc63

•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24

Other Name: REVLIMID

•Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8

Other Name: Decadron

•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8

Other Name: HuLuc63

•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24

Other Name: REVLIMID

10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8

40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8

This research study is aimed to determine the proportion of high risk smoldering multiple myeloma patients who are progression free at 2 years after receiving elotuzumab, lenalidomide and dexamethasone combination therapy.

This research study is a Phase II clinical trial, which tests the effectiveness of the investigational drugs elotuzumab, lenalidomide and dexamethasone in smoldering multiple myeloma. Recent research studies have shown that early treatment of smoldering multiple myeloma may delay or prevent the progression to active multiple myeloma. The purpose of this research study is to learn whether the combination of elotuzumab, lenalidomide and dexamethasone works in treating smoldering multiple myeloma.

E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma

E- PRISM: Precision Intervention Smoldering Myeloma: Phase II Trial of Combination of Elotuzumab, Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma

Percent of patients who are alive and without documented progression after at least 2-years of follow-up. All patients who receive study treatment are assessed including those who have died or lost to follow-up prior to 2-years. Progression was defined as an increase in SPEP \[25% and an absolute increase of 0.5g/d\] or UPEP \[25% and an absolute increase of 200mg/24hours\] on 2 successive evaluations as determined by the IMWG response criteria or documented progression by the FreeLite progressive disease criteria in the absence of serum or urine involvement.

Percent of patients with objective response defined as partial response or better based on the International Myeloma Working Group Response (IMWG) criteria

Time from initiation of therapy to progression defined by the IMWG criteria.

Bristol-Myers Squibb

Celgene

Blood Cancer Research Partnership

Multiple Myeloma Research Consortium

•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8

Other Name: HuLuc63

•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24

Other Name: REVLIMID

•Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8

Other Name: Decadron

Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8

Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24

Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8

Elo / Len / Dex

•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8

Other Name: HuLuc63

•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24

Other Name: REVLIMID

Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8

Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24

Elo / Len

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

0 = Normal activity. Fully active, able to carry on all pre-disease performance without restriction.

1= Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).

2 = In bed \<50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.

ECOG Performance Status

Dr. Irene Ghobrial

Percent of Patients Who Are Progression Free at 2 Years

Objective Response Percent

Time to Progression

Overall Survival

Overall Study

Patients with Monoclonal gammopathy of undetermined significance or smoldering myeloma

Gene expression profiling, DNA copy number variation

Genetic study of DNA copies

Olivier DECAUX, MD

The purpose of this study is to describe DNA copy number variations and gene expression profiles of bone marrow plasma cells of monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). The final objective is to search for correlations with the risk of progression in order to establish a predictive model of early malignant transformation.

Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From MGUS and SMM.

Large Scale Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From Monoclonal Gammopathy of Undetermined Significance (MGUS) and Indolent Myeloma (SMM).

Intergroupe Francophone du Myelome

Rennes University Hospital

Bortezomib

Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.

Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.

Maurizio Zangari, MD

OBJECTIVES

* Primary: To evaluate the bone anabolic effect of bortezomib in patients with smoldering myeloma.
* Secondary: To evaluate the effect of bortezomib on the natural history of smoldering myeloma.

Smoldering multiple myeloma (SMM) is usually followed expectantly without therapy. The overall risk of progression to active multiple myeloma has been estimated up to 20% in the first year from diagnosis (Kyle et al, 2007). An angiogenic switch has been postulated as a pivotal event in the progression from MGUS to smoldering myeloma. Two trials for advanced and refractory MM patients tested this hypothesis using Thalidomide as antiangiogenic agent in association with biphosphonates showing and effect on disease progression (Barlogie et al, 2008).

The ubiquitin-proteasome pathway, which has been shown to be an essential cellular degradative system in myeloma cells, also regulates bone formation though effects on osteoblast differentiation (Pennisi et al., 2008).

Retrospective analysis of ALP variation in 2 large Bortezomib trials in the refractory setting confirmed the finding. In the SUMMIT trial (Zangari, et al., 2005), 77 patients were evaluated. The media increment ALP in levels of responding patients (patients with \>50% decrease in paraprotein) upon completion of 3 cycles of therapy was statistically higher of those individuals with less than partial response (week 8, P=0.0015; responder range, 62-837 mL/L). In the APEX trial (Zangari et al. 2005), 422 patients were analyzed; 217 patients were randomized to bortezomib, 205 to dexamethasone. Within the bortezomib arm, the increment in serum ALP levels in responder patients (\>CR) was statistically higher at week 3 (P=0.014), week 6 (P=0.002; responder rage, 31-272 mL/L) and week 9 (P=0.036). Comparing only responders patients in both arms of the study, we observed a significantly higher median ALP increase in the bortezomib compared to the dexamethasone arm (P\<0.01; responder ran, 31-272 mL/L) (Zangari et al., 2007). A 25% increase in ALP (N=105) at week 6 was also the strongest indicator associated with quality of response (P\<0.0001) and also with the time to progression (206 vs. 169 days) relative to patients with less than a 25% increase in ALP (N=228; P=0.01) (Zangari et al., 2007). We will now test the bone anabolic effect of bortezomib in a cohort of smoldering multiple myeloma patients.

Study rationale and selection of drug doses VELCADE has been shown to produce an anabolic bone effect (increase bone ALP and osteocalcin) in relapsed/refractory patients. This study will examine the bone anabolic effect in patients with smoldering myeloma who, with a median age of 67 years, have frequent evidence of osteopenia not associated with lytic bone disease. Risk of disease progression is estimated at 10% per year in this patient population. The primary aim of this trial is to determine the effect of a short course (i.e. 9 cycles) of low-dose Bortezomib on bone remodeling and on disease progression. The dose of bortezomib used in this trial of 0.7 mg/m2 is the lowest dose which has shown efficacy in the 3 largest monotherapy trials with bortezomib. Seventeen percent of patients in the APEX 9% of patients in CREST and 24% in SUMMIT trials were treated with 0.7 mg/m2 dosages. Bortezomib will be given on days 1, 8, 15, 22 over 42 days to reduce the incidence of possible drug related side effects.

Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients

The primary endpoint is the change in bone Alkaline Phosphatase at baseline and 6 weeks.

Millennium Pharmaceuticals, Inc.

University of Utah

All participants enrolled.

Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.

Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.

Arm 1 Bortezomib

All participants enrolled.

Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m\^2 on days 1, 8, 15, and 22 of each 42 day cycle.

Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.

Arm -1 Bortezomib

Mark Wade

% Base Line Patient 1

% Base Line Patient 3

% Base Line Patient 4

% Base Line Patient 6

% Base Line Patient 7

% Base Line Patient 8

% Base Line Patient 10

% Base Line Patient 11

% Base Line Patient 13

% Base Line Patient 14

% Base Line Patient 15

% Base Line Patient 16

% Base Line Patient 17

Only 13 patents had bone alkaline phosphatase measured at the appropriate time points out of the 17 that completed the study

Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.

TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.

TBL12

Amitabha Mazumder, MD

This study proposes to determine the clinical activity of this agent in patients with asymptomatic multiple myeloma. It is believed that TBL12 will help delay the onset of active multiple myeloma, with very few-if any- side effects.

Multiple myeloma is a cancer that evolves from a state known as Monoclonal Gammopathy of Undetermined Significance (MGUS), defined by parameters of M spike and bone marrow. After evolution to myeloma, patients may be asymptomatic, that is, without any endorgan disease of hypercalcemia, renal insufficiency, anemia or bone lesions. In asymptomatic myeloma (ASxM), there is no standard therapy. Thalidomide has been tried in patients with ASxM but with significant toxicity. The patients with ASxM are evaluable in terms of paraprotein measurements.

TBL12 sea cucumber extract has been shown to have a number of antitumor properties preclinically, including antiangiogenesis and direct tumor cytotoxicity. TBL12 has been used by a number of patients as a food supplement without any toxicity detected. The investigators thus propose to determine the clinical activity of this agent in patients with ASxM. Patients will be given TBL12 at the dose of 2 units of 20 mL each twice per day daily until disease progression and the effects on the paraprotein noted. Clinical effects seen will be correlated with any in vitro changes in angiogenesis in patient bone marrow samples. The results of this trial may form the basis for the use of this nontoxic agent in patients with the prodrome of or with other early cancers.

A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

A Phase II Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

Response \[complete response (CR), partial response (PR), and stable disease (SD)\] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).

Response to TBL12 is defined as SD or better after 2 cycles of TBL12. The evaluation of SD, PR, or CR is based on the report by Blade et al. (1998)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma	NCT05597345	Smoldering Mult...	Selinexor	18 Years -	University of Rochester
S0309, Repository: Blood/Bone Marrow From Pts. With Myeloma, WM, Amyloidosis, or MGUS.	NCT00919139	Multiple Myelom... Smoldering Myel... Waldenstrom's M... Monoclonal Gamm... Amyloidosis	biologic sample...	-	SWOG Cancer Research Network
Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome	NCT02269592	Monoclonal Gamm... Chronic Lymphoc... Myelodysplastic... Hematological M... B-cell Malignan... Myelodysplastic... IgG Monoclonal ... Smoldering Mult... Waldenstrom Mac...		18 Years -	Dana-Farber Cancer Institute
E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma	NCT02279394	Smoldering Myel... Smoldering Mult...	Elotuzumab Lenalidomide Dexamethasone	18 Years -	Dana-Farber Cancer Institute
Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From MGUS and SMM.	NCT01079429	Monoclonal Gamm... Smoldering Myel...	Genetic study o...	18 Years - 70 Years	Rennes University Hospital
Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients	NCT00983346	Cancer Myeloma Multiple Myelom...	Bortezomib	18 Years -	University of Utah
Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From MGUS and SMM.	NCT01079429	Monoclonal Gamm... Smoldering Myel...	Genetic study o...	18 Years - 70 Years	Rennes University Hospital
Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From MGUS and SMM.	NCT01079429	Monoclonal Gamm... Smoldering Myel...	Genetic study o...	18 Years - 70 Years	Rennes University Hospital
S0309, Repository: Blood/Bone Marrow From Pts. With Myeloma, WM, Amyloidosis, or MGUS.	NCT00919139	Multiple Myelom... Smoldering Myel... Waldenstrom's M... Monoclonal Gamm... Amyloidosis	biologic sample...	-	SWOG Cancer Research Network
A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma	NCT01302366	Myeloma	TBL12	18 Years -	NYU Langone Health
Natural History Study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Myeloma (SMM)	NCT01109407	Smoldering Myel... Monoclonal Gamm...		18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for smoldering myeloma