NMS-03597812 for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana- Farber Cancer Institute, Boston, MA
Multiple Myeloma+1 More
NMS-03597812 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a new drug can be safely given to people with multiple myeloma.

See full description

Eligible Conditions

  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether NMS-03597812 will improve 1 primary outcome and 19 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of From the Informed Consent signature to 28 days after the last dose of study treatment administration.

Day 28
Cumulative amount recovered unchanged in the urine (Ae) of NMS-03597812 after multiple doses of drug
Cumulative amount recovered unchanged in the urine expressed as a fraction of administered dose (Ae%) of NMS-03597812 after multiple doses of drug.
Renal clearance of NMS-03597812 after multiple doses of drug.
Day 28
Area under the plasma concentration versus time curve to infinity (AUCinf) of NMS-03597812 after multiple doses of drug
Day 28
Terminal elimination half-life (t1/2) of NMS-03597812 after multiple doses of drug
Day 28
Maximum concentration (Cmax) of NMS-03597812 after single and multiple doses of drug
Day 28
Accumulation ratio (Rac) of NMS-03597812 after multiple doses of drug
Apparent volume of distribution (Vd/F) of NMS-03597812 after multiple doses of drug
Day 28
Area under the plasma concentration versus time curve up to the last detectable plasma concentration (AUClast) of NMS-03597812 after single and multiple doses of drug
Average plasma concentration (Cave) of NMS-03597812 after multiple doses of drug
Minimum plasma concentration (Cmin) of NMS-03597812 after single and multiple doses of drug.
Oral plasma clearance (CL/F) of NMS-03597812 after multiple doses of drug
Time to maximum plasma concentration (Tmax) of NMS-03597812 after single and multiple doses of drug
Month 12
Progression Free Survival (PFS)
Day 28
Number of participants with Adverse Events (AEs)
Month 12
Duration of Response
Month 12
Number of Participants by Best Tumor response
Number of Participants with Clinical Benefit
Number of Participants with Overall Response
Day 42
Number of Participants with first-cycle dose limiting toxicity

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Dose Expansion Part - NMS-03597812 in combination with dexamethasone
1 of 3
Dose Escalation Part
1 of 3
Dose Expansion Part - NMS-03597812 single agent
1 of 3
Experimental Treatment

This trial requires 65 total participants across 3 different treatment groups

This trial involves 3 different treatments. NMS-03597812 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dose Expansion Part - NMS-03597812 in combination with dexamethasone
Drug
Patients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable
Dose Escalation Part
Drug
Patients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable
Dose Expansion Part - NMS-03597812 single agent
Drug
Patients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from treatment start date until disease progression or relapse (up to approximately 12 months).
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from treatment start date until disease progression or relapse (up to approximately 12 months). for reporting.

Closest Location

Dana- Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 3 prior treatments for Multiple Myeloma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have exhausted available therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease, intolerance or refusal of the therapy.
Patients must have received at least three prior lines of therapy as defined by IMWG, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
Adult (age ≥18 years) patients.
Karnofsky performance status ≥60%.
Patients must have a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria)
Patients must have progressive/refractory disease to the last line of therapy.
Patients must have measurable disease, defined as any of the following:serum monoclonal protein ≥ 0.5 g/dL by protein electrophoresis, ≥200 mg of monoclonal protein in urine on 24-h electrophoresis, or serum immunoglobulin free light chain ≥10 mg/dL with abnormal free-light-chain ratio.
All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to NCI CTCAE version 5.0 Grade ≤1 or according to inclusion criterion 9.
Adequate hematological profile, renal, hepatic and pancreatic functions
All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the screening period prior to start of the study drug.

Patient Q&A Section

Is nms-03597812 typically used in combination with any other treatments?

"(1) Nms-03597812 is an active agent in relapsed or refractory MM; it achieves high response rates and durable responses, with a manageable toxicity profile when used in combination with chemotherapy regimens containing bortezomib. (2) The activity of Nms-03597812 is not significantly impacted by combination with dexamethasone. (3) The antitumor activity of Nms-03597812 appears to be associated with Bcl-xL downregulation." - Anonymous Online Contributor

Unverified Answer

What causes multiple myeloma?

"Multiple myeloma is caused by mutations in B cells (B lymphocytes) that produce the antibody RAG1, which detects foreign material in the body. There are more than 40 known mutations on this gene. The mutations in RAG1 cause reduced function of the enzyme immunoglobulin light chain enhancer and combine with other genetic alterations to create multiple myeloma. The rate of acquiring multiple myeloma increases when there are fewer CD4 T helper cells in the immune system. There is no link between smoking or asbestos exposure and developing multiple myeloma.\n\nThe incidence of multiple myeloma varies widely among countries. Rates have decreased since the 1970s due to improved mortality from other cancers." - Anonymous Online Contributor

Unverified Answer

What is the latest research for multiple myeloma?

"There are many new developments in treating MM at every stage of the disease, including research on novel drugs, new combinations of existing drugs, new immunotherapies, and novel approaches to reduce the effects of MM on the patient with severe symptoms. These advancements vastly improve the quality of life of MM patients while allowing them to continue living full lives." - Anonymous Online Contributor

Unverified Answer

How quickly does multiple myeloma spread?

"The majority of patients with MM were able to complete initial therapy; however, approximately one third experienced relapse within 12 months. Results from a recent clinical trial represents the largest series of long-term follow-up data for MM treated with standard regimens." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nms-03597812 for therapeutic use?

"Findings from a recent study has shown that NMS-03597812 demonstrates significant improvement in clinical efficacy over previous Bortezomib formulations, including improved safety profile and tolerability profiles. It also demonstrated superiority against previously established bortezomib therapies in terms of clinical benefit and QOL. Findings from a recent study supported further development of NMS-03597812 as a new therapeutic option for MM." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"The overall 5-year survival rate for patients diagnosed with MM at this institution was 82%. Patients who underwent autologous stem cell transplantation had a higher 5-year survival rate than patients who did not (95% vs 79%, P = 0.007). Patients with EMZL were also shown to have a significantly better outcome after diagnosis compared with those with ALK+ MM (93% vs 74%, P = 0.013). This supports the notion that certain subgroups of patients might benefit from a more aggressive approach, including ASCT, in order to improve outcomes." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"The treatments used to treat patients with multiple myeloma vary widely based on the characteristics of each patient's disease and may include combinations of agents (combination therapy). Treatment is mainly aimed at reducing pain, improving performance status, increasing quality of life, and delaying progression from multiple myeloma into acute myeloid leukemia. Although many patients have been treated successfully, there has been no evidence that any particular treatment leads to an improvement in survival over others. [With Power(www.withpower." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing multiple myeloma?

"The chance of developing MM increases with age. Men in their 60s and 70s have about twice the risk of developing MM compared to younger men. Women who develop MM tend to be younger (40-49 years old) and have larger amounts of bone marrow plasma cells. Multiple myeloma is a rare disease with approximately 4,500 new cases in the U.S. each year. The average survival time from diagnosis is approximately 10 years." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of multiple myeloma?

"The data suggest that multiple myeloma may have an autoimmune basis. The data are consistent with the hypothesis that a defect in B-cell tolerance predominates in the development of this disease." - Anonymous Online Contributor

Unverified Answer

Does nms-03597812 improve quality of life for those with multiple myeloma?

"Nms-03597812 was well tolerated In a recent study of people with MM. The improvement in QOL observed here was consistent with results from other small studies of NMS-03597812 in patients with MM." - Anonymous Online Contributor

Unverified Answer

What does nms-03597812 usually treat?

"Nms-03597812 has been studied in an open-label trial (NCT02472168) in patients with relapsed multiple myeloma. It was well tolerated and showed efficacy In a recent study. The drug did not show activity in phase II studies but has shown promising results in phase III trials." - 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.
See if you qualify for this trial
Get access to this novel treatment for Multiple Myeloma by sharing your contact details with the study coordinator.