STI-1492 for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Oklahoma, Oklahoma City, OK
Multiple Myeloma+1 More
STI-1492 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Study to Assess Allogeneic Anti-CD38 A2 Dimeric Antigen Receptor T Cells in Relapsed or Refractory Multiple Myeloma

See full description

Eligible Conditions

  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Multiple Myeloma

Study Objectives

This trial is evaluating whether STI-1492 will improve 1 primary outcome and 3 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Baseline through study completion at up to approximately 54 months.

Month 54
Assessment of improvements in hypercalcemia, renal function, anemia and lytic bone lesions (CRAB criteria)
Assessment of serum immunoglobulin levels
Overall response and duration
Safety of STI-1492

Trial Safety

Safety Progress

1 of 3

Other trials for Multiple Myeloma

Trial Design

1 Treatment Group

STI-1492
1 of 1
Experimental Treatment

This trial requires 54 total participants across 1 different treatment group

This trial involves a single treatment. STI-1492 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

STI-1492
Biological
Four dosing cohorts will be evaluated: Cohort 1 (1 × 10^5 donor DAR-T cells/kg); Cohort 2 (5 × 10^5 donor DAR-T cells/kg); Cohort 3 (1 × 10^6 donor DAR-T cells/kg); Cohort 4 (3 × 10^6 donor DAR-T cells/kg) where STI-1492 will be administered intravenously once.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through study completion at up to approximately 54 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline through study completion at up to approximately 54 months for reporting.

Closest Location

University of Oklahoma - Oklahoma City, OK

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Must have relapsed or refractory multiple myeloma (RRMM) after having received prior lines of anti-myeloma treatments.
Measurable disease as defined by one of the following: abnormal serum or M-protein levels; abnormal serum free light chain (FLC) assay; ≥ 30% clonal plasma cells in the bone marrow aspirate or biopsy sample
Evidence of cell membrane CD38 expression as determined by immunohistochemistry (IHC) analysis ofbone marrow biopsy or extramedullary plasmacytoma
Pulse oximetry ≥ 92% on room air
Have a life expectancy ≥ 12 weeks
Be willing and able to comply with the study schedule and all study requirements
Willing to follow contraception guidelines

Patient Q&A Section

What is multiple myeloma?

"Multiple myeloma is a cancer that typically develops slowly, at a rate of one or fewer new cases a year, within weeks to months. The tumor is typically and almost always secretes the abnormal protein myeloma light chain, which is detectable in the blood. It commonly involves the bone marrow and lymph nodes. It is usually fatal in its early stages, but when treated, long-term survival rates can be achieved. A complete remission is not always obtained, and relapse may occur. The disease can occur in either new cases of multiple myeloma or in cases where the individual has had remissions but has suffered new episodes of disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"MM causes enlargement of the spleen and the bone marrow. Other signs include low [back pain](https://www.withpower.com/clinical-trials/back-pain), itching and numbness, fatigue, weight loss, loss of appetite, abdominal pain, diarrhea, constipation, and blurred vision." - Anonymous Online Contributor

Unverified Answer

How many people get multiple myeloma a year in the United States?

"Fewer than 10,000 people per year get American with myeloma. In the United Kingdom, the incidence is comparable, and the risk of getting lymphoproliferative disease is higher than in the United States, accounting for most of the excess mortality. This is more likely to be attributable to the higher incidence of multiple myeloma in the United Kingdom." - Anonymous Online Contributor

Unverified Answer

What causes multiple myeloma?

"The specific cause of multiple myeloma remains unknown. It is hypothesized that some genetic alterations lead to malignant plasma cell proliferation and, thus, clinical presentation of the disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"In this population-based sample of people with newly diagnosed MM, more than half had an active treatment and had some treatment for MM. A large number of patients with newly diagnosed MM underwent multiple active treatments." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"With current treatment, a significant proportion of patients can expect to survive 5 years or more without disease progression. Long-term surveillance or prophylactic treatment should be considered in high-risk patients. Future trials will have to make a more rigorous and consistent definition of progression-free survival, e.g. using the European Commission definition of response. Newer anti-immunoglobulin therapies have now been tested in phase II trials and have shown strong activity in multiple myeloma but more data is being needed to elucidate their role in the treatment of this disease." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for multiple myeloma?

"As multiple myelomas progress, symptomatic improvement is needed and patients may not want standard treatment, which might include supportive care and supportive care alone. Physicians should consider multiple myeloma clinical trials." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of sti-1492?

"The most common side effects from sti-1492 can be categorized into three categories: (1) skin and subcutaneous reactions, (2) GI tract reactions and (3) bone reaction or pain. The most common side effects are a mild decrease of neutrophil and thrombocytosis at the beginning of the administration of the drug, whereas no effect on the neutrophils and platelets were observed at the end of the administration of sti-1492. No haemorrhagic complication was observed in any of the patients. There was no effect on their serum glucose level, and no significant increase on the serum creatinine level was observed at the end of the administration of sti-1492." - Anonymous Online Contributor

Unverified Answer

How serious can multiple myeloma be?

"There were few similarities between those patients with and without complications, including a slightly greater prevalence of smoking. There were weak correlations between BMI and biochemical parameters in our study, but this result awaits confirmation in prospective evaluations." - Anonymous Online Contributor

Unverified Answer

How does sti-1492 work?

"Results from a recent clinical trial we have demonstrated that Sti-1492, a synthetic small molecule TKI, induces apoptosis in multiple myeloma cells in vitro, suggesting that it may represent a potentially new class of selective agents." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for multiple myeloma?

"Survival analysis indicates survival benefit of autologous stem cell [transplant](https://www.withpower.com/clinical-trials/transplant)ation and high-dose thalidomide. With current treatment it is hard to predict what patient or treatment will result in improved survival rates or if improved survival can be expected at all in future treatment strategies for multiple myeloma." - Anonymous Online Contributor

Unverified Answer

Has sti-1492 proven to be more effective than a placebo?

"Recent findings indicate that in our study, Sti-1492 is highly effective in ameloblastoma. This result adds new insight into our knowledge of the anti-oncogenic activity of the TAK-232 analog, and reinforces the concept of Sti-1492 as a potential candidate for the development of a novel anti-cancer drug." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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