MMprofiler SKY92 gene signature for Multiple Myeloma

Phase-Based Estimates
1
Effectiveness
1
Safety
Weill Cornell Medicine, New York, NY
Multiple Myeloma+1 More
MMprofiler SKY92 gene signature - Device
Eligibility
18+
All Sexes
Eligible conditions
Multiple Myeloma

Study Summary

This study is evaluating whether a tool which helps doctors and patients understand the risks and benefits of different treatments for multiple myeloma will help patients make better treatment decisions.

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Eligible Conditions

  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether MMprofiler SKY92 gene signature will improve 1 primary outcome and 4 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 5 years after diagnosis.

3 years after diagnosis
3 year Overall Survival
3 year Progression Free Survival
5 years after diagnosis
5 year Overall Survival
5 year Progression Free Survival
Week 4
Change in treatment intention

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
MMprofiler SKY92

This trial requires 250 total participants across 2 different treatment groups

This trial involves 2 different treatments. MMprofiler SKY92 Gene Signature is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

MMprofiler SKY92
Device
Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: treatment intention is measured before mmprofiler sky92 and within 4 weeks after mmprofiler
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly treatment intention is measured before mmprofiler sky92 and within 4 weeks after mmprofiler for reporting.

Closest Location

Weill Cornell Medicine - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Candidates for systemic treatment
Multiple myeloma is a potentially life-threatening cancer that begins in plasma cells, a type of white blood cell show original

Patient Q&A Section

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

What is multiple myeloma?

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It typically forms in the bone marrow in people with an underactive immune system. Symptoms include pain in one or more bones and in the jaw, or numbness or weakness in one or both legs.\n

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What causes multiple myeloma?

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The cause(s) of M.E. are not well understood. This is mainly because M.E. affects less than 2% of individuals with multiple myeloma, so many patients could be missed. The disease is usually slowly progressive, but it can resolve on some rare occasions, and has some treatments available. Many of the rare disorders with which M.E. has been associated, may be caused by chromosomal or genetic abnormalities that affect multiple myeloma risk and/or progression of the disease.

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Can multiple myeloma be cured?

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MM is typically responsive to therapies. The treatment of MM must be individualized; for some patients, even if treatment is discontinued during remission, relapse is common. The best response, duration to treatment, and durability of response to therapy should therefore be monitored frequently. The treatment of MM is often demanding and requires coordination of care, both within and among health care providers.

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What are common treatments for multiple myeloma?

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The treatment options for multiple myeloma are highly dependent on the specific patient. Common treatments include the combined use of prednisone, thalidomide, bortezomib, and lenalidomide. There is no cure for multiple myeloma, but many patients may be in comfort for years until their disease worsens.

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What are the signs of multiple myeloma?

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Patients with MM may have non-specific signs and symptoms indicating a serious cancer in the bone marrow, and some changes in blood parameters may appear in MM. Other signs may develop with the disease progression. Therefore, proper evaluation of patients with MM needs to include a complete examination of the bone marrow aspiration and biopsy.

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

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It is estimated that the number of new cases of both ALK-negative and ALK-positive multiple myeloma cases is approximately one cases per year per 100,000 individuals in the US, a very large number given that a large, mature, population has lived and died throughout history. It is therefore likely that multiple myeloma is a rare tumor in most populations, and a potentially under-recognized disease in the public.

Unverified Answer

What is the survival rate for multiple myeloma?

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Myeloma has a mean relative survival of 5 years in the United States. For an individual, survival could range up to 10 to 15 years. Survival for individuals in Canada is about 7 years. Most patients with myeloma also live longer than 5 years even after diagnosis. The relative survival decreases from a 10- to 13-year survival (myeloma as a whole versus multiple myeloma) in Europe and Japan to 4- to 8-year survival in the United States by disease stage. Survival time for an individual myeloma patient at diagnosis is one factor to consider when deciding on therapy for treatment.

Unverified Answer

Does mmprofiler sky92 gene signature improve quality of life for those with multiple myeloma?

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MM profiler skysh92 gene signature improved quality of life in patients with MM in this population. Results from a recent clinical trial support further exploration with larger and more diverse populations.

Unverified Answer

Is mmprofiler sky92 gene signature typically used in combination with any other treatments?

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In MM samples the Sky92 predictive gene signature is significantly superior to most of the available gene-classifying scores, and therefore should be used only in combination with other therapy modalities.

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Who should consider clinical trials for multiple myeloma?

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When deciding which patients are appropriate for clinical trials, it is of utmost importance that the patients be thoroughly informed about the risks, benefits, and expectations of their participation. A patient with myeloma must be thoroughly informed about the possible consequences of treatment as well as the overall treatment plans, including any expected treatment modifications. It is highly advisable that the patients' treating physicians make it a priority to discuss clinical trial topics with their patients before they decide to participate in their treatment programs.

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How does mmprofiler sky92 gene signature work?

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mmprofiler Sky92 gene signature is a potential new predictor of clinical outcome in patients with multiple myeloma, and thus it has the potential to be used as a new clinical biomarker for multiple myeloma.

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What is mmprofiler sky92 gene signature?

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Findings from a recent study shows several novel gene signature combinations associated with MM progression. We demonstrate the potential of mmprofiler Sky92 gene signature in predicting the probability of progression in patients with newly diagnosed MM, in addition to the OS and PFS. Findings from a recent study also provide a basis for studying the molecular mechanisms underlying the progression of MM.

Unverified Answer
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.