Myeloma Clinical Trial
Official title:
A Phase II Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03832127 -
Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients
|
Phase 1 | |
| Completed |
NCT01413178 -
A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
|
Phase 3 | |
| Recruiting |
NCT03641456 -
VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma
|
Phase 2 | |
| Terminated |
NCT02907073 -
Positron Emission Tomography (PET) Imaging Studies With NIS Reporter
|
Phase 1/Phase 2 | |
| Completed |
NCT03135925 -
Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation
|
N/A | |
| Withdrawn |
NCT02114502 -
Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma
|
Phase 2 | |
| Completed |
NCT00794261 -
Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma
|
Phase 2 | |
| Completed |
NCT00800839 -
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide
|
Phase 2 | |
| Completed |
NCT01700608 -
Prospective Observational Study on Plerixafor After Chemotherapy
|
N/A | |
| Completed |
NCT00606437 -
Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants
|
Phase 1 | |
| Recruiting |
NCT05528887 -
Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies
|
Phase 1 | |
| Recruiting |
NCT05625971 -
Non-invasive MRD Assessment in Multiple Myeloma
|
||
| Active, not recruiting |
NCT02931942 -
Changing Over Time of Ascorbic Acid After Chemotherapy
|
||
| Active, not recruiting |
NCT05889221 -
Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma
|
N/A | |
| Recruiting |
NCT03836690 -
Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation
|
Phase 1 | |
| Active, not recruiting |
NCT02542657 -
Ixazomib With Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients With Multiple Myeloma
|
Phase 1/Phase 2 | |
| Completed |
NCT01279694 -
Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma (CARMYSAP)
|
Phase 1/Phase 2 | |
| Completed |
NCT01191060 -
Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years
|
Phase 3 | |
| Terminated |
NCT00983346 -
Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients
|
Phase 2 | |
| Completed |
NCT00476294 -
Long-Term Follow Up Study for AMD3100 Patients
|
N/A |