CLINICAL TRIAL

dexamethasone for Multiple Myeloma

Waitlist Available · 18+ · All Sexes · Boston, MA

This study is evaluating whether a new drug combination is effective in treating patients with primary amyloidosis or light chain deposition disease.

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About the trial for Multiple Myeloma

Eligible Conditions
Multiple Myeloma · Immunoglobulin Light-chain Amyloidosis · Amyloidosis · Primary Systemic Amyloidosis (AL) · Light Chain Deposition Disease

Treatment Groups

This trial involves 2 different treatments. Dexamethasone 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 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
dexamethasone
DRUG
laboratory biomarker analysis
OTHER
quality-of-life assessment
PROCEDURE
melphalan
DRUG
microarray analysis
GENETIC
flow cytometry
OTHER
bortezomib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
quality-of-life assessment
2012
Completed Phase 3
~2780
Melphalan
FDA approved
microarray analysis
2006
Completed Phase 3
~3850
Bortezomib
FDA approved

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Primary systemic amyloidosis
Histochemical diagnosis of amyloidosis determined by polarizing microscopy of green bi-refringent material in Congo red-stained tissue specimens or characteristic electron microscopy appearance
Light chain deposition disease
Serum monoclonal protein ≥ 0.5 g/dL by serum electrophoresis
Urine monoclonal protein > 200 mg/tv in a 24 hr urine electrophoresis
Serum immunoglobulin free-light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa lambda free light chain ratio
Clonal population of plasma cells in the bone marrow (≤ 30%)
Immunohistochemical stain with anti-light chain anti-sera of amyloid fibrils
Lytic lesions on skeletal survey
Plasmacytoma
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether dexamethasone will improve 1 primary outcome and 6 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Day 1 of Each Cycle.

Time to Treatment Failure
DAY 1 OF EACH CYCLE
Toxicity, Including Neurotoxicity
DAY 1 OF EACH CYCLE
Overall Survival
DAY 1 OF EACH CYCLE AND EVERY 12 WEEKS AFTER LAST TREATMENT CYCLE
Overall Hematologic Response Rate (OHR)
BEGINNING OF CYCLES 4, 8, 12, 16 AND 20, AT FOLLOW UP AND END OF STUDY.
Organ Response Rate (OrR)
BEGINNING OF CYCLES 4, 8, 12, 16 AND 20, AT FOLLOW UP AND END OF STUDY.
Change in Quality of Life From Baseline as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Questionnaire.
AT THE START OF EACH CYCLE
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Who is running the study

Principal Investigator
J. Z.
Jeffrey Zonder, Principal Investigator
Barbara Ann Karmanos Cancer Institute

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 are the signs of multiple myeloma?

Muscle tenderness, unexplained weakness, or loss of appetite are early signs of myeloma and can be observed by both patients and caregivers. They are important not only because they alert both the patients and the caregivers to the presence of myeloma but because they allow clinicians to confirm the diagnosis early. The pain caused by myeloma and

Anonymous Patient Answer

What is multiple myeloma?

Multiple myeloma is a chronic blood disease in which bone marrow-derived plasma cells are made abnormally. As a result, blood clots may form in the bloodstream and block arteries or veins. These clots can cause painful or fatal ischemic events.\n\nThe purpose of this article is to describe the types of cancer and to provide a brief review of the risk factors associated with cancer.

Anonymous Patient Answer

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

An estimated 1 in 25,000 US adults are diagnosed with multiple myeloma a year. The disease most commonly affects whites and men aged 70 or older. Multiple myeloma is strongly linked with multiple myeloma mortality.

Anonymous Patient Answer

What causes multiple myeloma?

Although multiple myeloma is a rare bone disease, multiple myeloma may be the most common bone disorder with a high likelihood of the disease occurring in the elderly populations. It was found the risk of multiple myeloma would be 3- to 4-times if the patient was diagnosed with an autoimmunity, especially if the autoimmunity was caused by the use of bisphosphonate medications.

Anonymous Patient Answer

Can multiple myeloma be cured?

The use of a standardized induction regimen followed by BCT is associated with substantial improvements in both event-free and overall survival in newly diagnosed patients with MM, similar to that seen with high-risk standard-risk patients.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

Although no drugs are known to be curative for multiple myeloma, many therapies have been found to improve both survival and quality of life for those who survive this disease. Targeted therapies include immunotherapy or immunomodulatory agents, which target the immune system; and immunosuppressive agents, which impair the immune system. New biologic drugs targeting specific proteins and receptors have also emerged; however, their role in treating multiple myeloma remains obscure. The prognosis of multiple myeloma is difficult to predict, largely due to the highly variable response to treatment. Despite our better understanding of the disease, many patients still respond poorly to treatment. New agents are likely to have profound impact on the course of this disease.

Anonymous Patient Answer

What is the survival rate for multiple myeloma?

The survival rate for patients with multiple myeloma depends on the type of treatment they receive and how long they have a stable treatment plan. If people keep on receiving treatment, the percentage of cancer death that is related to cancer slowly but persistently decreases. It is important to be aware that a diagnosis of multiple myeloma does not mean that a person is going to die. The survival rate varies among patient populations. Therefore, it is hard to give an average survival rate. For example, people being treated more intensively are likely to live longer than persons from other groups. Another way patients, families of patients, and their physicians, need to keep aware is to make careful decisions on the type and number of treatments.

Anonymous Patient Answer

What does dexamethasone usually treat?

Patients with multiple myeloma should reduce their steroid medication and should not take it after a bout of fevers with a high cytokine peak (IL-6 or TNF-α).

Anonymous Patient Answer

Have there been other clinical trials involving dexamethasone?

Given the lack of clinical trials evaluating the long-term effects of corticosteroids, it is difficult to make conclusions about them. We argue that since they are an extremely commonly used drug with a relatively good side effect profile, further studies of this drug are still warranted.

Anonymous Patient Answer

How quickly does multiple myeloma spread?

Multiple myeloma does not spread very quickly. This is of concern because it is an incurable disease. There is no cure for multiple myeloma as we know it. There is still a long way to go to find an effective cure for the disease.

Anonymous Patient Answer

How serious can multiple myeloma be?

Findings from a recent study of this study show that the risk of death in patients with myeloma is higher than average. This data should be taken into account in discussions that occur when treatment protocols for this disorder are being developed.

Anonymous Patient Answer

Does multiple myeloma run in families?

The study results suggest that multiple myeloma runs in families. Findings from a recent study confirm the theoretical prediction that in a genetic study of multiple myeloma, one should expect to find a high concordance rate between families ascertained from an unrelated sample and a sample ascertained from a multiple myeloma-affected individual.

Anonymous Patient Answer
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