Next Generation Sequencing for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, OH
Multiple Myeloma+1 More
Next Generation Sequencing - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether melphalan is effective in killing multiple myeloma cells.

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 Next Generation Sequencing will improve 1 primary outcome and 6 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of After treatment, day 15.

After treatment, day 15
Residual myeloma cell number measured by NGS
Day 52
Percent of participants with diarrhea and oral mucositis and other non-hematologic toxicities
Percent of participants with engraftment failure
Percent of participants with post-transplant period safety
Percent of participants with safety stopping endpoints
Day 1
Percent of participants with pre-transplant period safety
Toxicity in pre-transplant period assessed according to CTCAE v. 5.0

Trial Safety

Safety Progress

1 of 3

Other trials for Multiple Myeloma

Trial Design

1 Treatment Group

Evomela (Melphalan)
1 of 1
Experimental Treatment

This trial requires 20 total participants across 1 different treatment group

This trial involves a single treatment. Next Generation Sequencing 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.

Evomela (Melphalan)Participants will receive Evomela 16 mg/m2 on day 1 of the study only. Evomela will be given as IV infusion over 30 minutes after administration of 500 cc normal saline as pre-hydration and pre-medications Prochlorperazine, Acetaminophen, and Diphenhydramine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Next Generation Sequencing
2018
N/A
~110
Prochlorperazine
FDA approved
Acetaminophen
FDA approved
Diphenhydramine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days 1, 8, 15, and 52
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly days 1, 8, 15, and 52 for reporting.

Closest Location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who have received at least three cycles of treatment including a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) plus lenalidomide or daratumumab and have future plans for an autologous stem cell transplant are eligible to participate in this study. show original
Participants must have had their cancer progress after at least one prior therapy. show original
People who want to participate in the study must have at least 100 mg/dL or 0.1 gr/dL of monoclonal protein on their serum electrophoresis and immunofixation tests. show original
, ECOG performance status of 0-2, and measurable disease Participants with myeloma must have symptoms, a performance status of 0-2, and measurable disease. show original
The serum ALT level is ≤ 3.5 times the upper limit of normal. show original
No serum direct bilirubin level is needed for initiation of therapy if the patient is not jaundiced. show original
A person's creatinine clearance must be at least 40 milliliters per minute within 21 days prior to starting therapy in order to be eligible for the therapy show original
Hemoglobin ≥ 10.0 g/dl
At least three million cells per kilogram must be collected within one or multiple days. show original
Individuals with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and a life expectancy of ≥ 12 months. show original

Patient Q&A Section

How quickly does multiple myeloma spread?

"Recent findings indicate that the frequency of bone marrow involvement increases with time after diagnosis of myeloma. However, these results need to be taken cautiously because most patients enrolled In a recent study were enrolled within 1 year of diagnosis. In addition, all patients were treated in one institution, so generalizability of these findings cannot be assumed." - Anonymous Online Contributor

Unverified Answer

Is next generation sequencing safe for people?

"The median number of changes detected was 2.5 (range 0–39). 18% of patients had ≥3 copy number changes, and 12% had ≥9 copy number alterations. Most common changes were recurrent gains of 1q21.1, 5q34, 8q24.1, 9p13.33-p24.1, 15q11.2-q13, 20q12.1, Xp11.22, Xp11.23, Xq21.1 and XXY. Receipt of lenalidomide plus dexamethasone significantly reduced the rate of progression compared with standard therapy alone." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"Recent findings suggest that MM does not necessarily have to be inherently lethal. Instead, it appears to be more likely to be incurable if the disease progresses quickly." - Anonymous Online Contributor

Unverified Answer

What is next generation sequencing?

"NGS is an effective tool to discover novel genetic mutations associated with MM/CLL. Data from a recent study sheds light on the evolution of this disease, which will help us understand its pathogenesis and development." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of next generation sequencing?

"NGS is a powerful tool for identifying specific mutations. However, it also generates ordering information on somatic mutations and the frequency of these mutations. The issue of the 'trivial' variants needs more attention in future research. More importantly, it is important to consider the potential significance of the variants identified in patients with MM." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for multiple myeloma?

"There is no good evidence supporting any particular risk factors for clinical trial enrollment in MM, other than age>or=65. Clinical trial enrollment criteria must be specified so that patients with more favorable baseline characteristics will enroll in trials. The two most important factors were an excellent performance status and low levels of bone marrow suppression during induction therapy." - Anonymous Online Contributor

Unverified Answer

How serious can multiple myeloma be?

"Multiple myeloma has two major subgroups, one with a very good prognosis (PFS >30 months) and another where PFS is <6 months and OS <9 months. The difference could be due to differences in treatments. Recent findings support the use of more intensive therapies in patients who are at higher risk of relapse or progression. Recent findings of our analysis suggest that there is a group of patients who may benefit from such a strategy." - Anonymous Online Contributor

Unverified Answer

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

"About one in twenty Americans will develop multiple myeloma every year; however, only 1 out of 5 will survive at least five years after diagnosis. Multiple myeloma occurs between age 70 and 80. The overall amount of new cases diagnosed each year is about 900 per million population. As many as 90% of newly diagnosed patients will die within 5 years." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"I am sorry to tell you that multiple myeloma cannot be cured; however, current treatments for this cancer have improved the chances of survival when compared to 5 years ago. In addition, improvements have been seen in the ability to control blood cell production, which in turn has significantly improved overall survival rates. Multiple myeloma is an incurable disease that requires ongoing clinical trials and supportive care. So far, some of the most effective treatments include autologous stem cell transplantation, bortezomib, thalidomide, lenalidomide, and proteasome inhibitors." - Anonymous Online Contributor

Unverified Answer

What does next generation sequencing usually treat?

"Most patients with MDS are treated with different combinations of agents used to treat hematological malignancies including tyrosine kinase inhibitors (including imatinib), alkylating agents (including temozolomide), and antimetabolites (which include azacitidine and decitabine). The use of NGS to identify genetic aberrations has led to the development of novel treatments for MDS. These treatments include bortezomib, lenalidomide, pomalidomide, and thalidomide. A number of studies have reported improved survival with these agents versus older treatment options." - Anonymous Online Contributor

Unverified Answer

What causes multiple myeloma?

"The above findings suggest that exposure to immunosuppressive drugs may be a risk factor for developing multiple myeloma. However, the role of cancer-related factors remains unclear." - 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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