Dexamethasone for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of North Carolina, Chapel Hill, NC
Multiple Myeloma+2 More
Dexamethasone - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM

See full description

Eligible Conditions

  • Multiple Myeloma
  • Multiple Myeloma (MM)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Multiple Myeloma

Study Objectives

This trial is evaluating whether Dexamethasone will improve 1 primary outcome, 9 secondary outcomes, and 2 other outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 5 Years.

5 Years
Alliance Geriatric Assessment with IMWG Fragility Score
Changes in Body Composition After Induction Therapy
Circulating MM cells and circulating DNA through DNA sequencing
Impact of Study Treatment on Progression Free Survival (PFS)
Minimal Residual Disease (MRD)
Overall Response Rate (ORR)
Overall Survival (OS)
Quality of Life with the EORTC QLQ-C30 Questionnaire
Quality of Life with the EORTC QLQ-MY20 Questionnaire
Quality of Life with the EQ 5D 5L Questionnaire
Rate of Adherence to Lenalidomide and Ixazomib
Toxicity Profile of Treatment Arm Based on Patient Response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Multiple Myeloma

Trial Design

2 Treatment Groups

Lenalidomide
1 of 2
Lenalidomide, Ixazomib, Daratumumab, and Dexamethasone
1 of 2
Experimental Treatment

This trial requires 188 total participants across 2 different treatment groups

This trial involves 2 different treatments. Dexamethasone is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Lenalidomide12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy.
Lenalidomide, Ixazomib, Daratumumab, and Dexamethasone12 cycles of lenalidomide, ixazomib, dexamethasone, and daratumumab followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 year maintenance therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved
Dexamethasone
FDA approved
Lenalidomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Closest Location

University of North Carolina - Chapel Hill, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Multiple Myeloma or one of the other 2 conditions 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:
Patient must be at least 18 years of age.
Serum involved/uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100 mg/L (a patient's involved free light chain, either kappa or lambda, is the one that is above the normal reference range; the uninvolved free light chain is the one that is typically in, or below, the normal range).
Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma
Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL).
Renal insufficiency: creatinine clearance <40 mL per minute or serum creatinine >177 mol/L (>2 mg/dL).
Anemia: hemoglobin value of >20 g/L below the lowest limit of normal, or a hemoglobin value <100 g/L.
Bone lesions: one or more osteolytic lesion on skeletal radiography, CT, or PET/CT. If bone marrow has <10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement.
Sixty percent (60%) or greater clonal plasma cells on bone marrow examination.
More than one focal lesion on MRI that is at least 5 mm or greater in size.
IgG myeloma: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or IgA, IgM, or IgD multiple myeloma: serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10mg/dL;

Patient Q&A Section

What causes multiple myeloma?

"It is difficult to determine the cause of MM, but it may be a combination of genetic and environmental factors. The risk of developing MM can be significantly reduced by cigarette smoking, avoiding ultraviolet exposure (including the sun), and drinking alcohol in moderation. Although exposure to certain infectious diseases has been linked to some cases of MM, its significance is unclear, and no major environmental toxins have been unequivocally linked." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"Many signs of osteolytic disease were present. A low B cell count may be present. Oedema may occur which may be symmetrical or distributed and may be associated with renal dysfunction or anaemia. In the setting of bone pain, bone pain may be tender to palpation.\n" - Anonymous Online Contributor

Unverified Answer

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

"There are 20,600 to 50,850 new cases of MM a year in this country, about two thirds of which are patients in their seventies. MM accounted for around 23% of all patients with multiple myeloma (NIA Registry of the National Institute of Arthritis and Muscular Dystrophy). Approximately 12,000 patients with MM die from the disease annually, making it the second most lethal malignancy in patients older than 65 years (Census bureau, Bethesda, MD, 2005; Cancer and Comorbidity Report, 2010)." - Anonymous Online Contributor

Unverified Answer

What is multiple myeloma?

"Multiple myeloma affects about 2% of people over the age of 35 and a lifetime risk of about 2–4%. By comparison, the lifetime risk of lung cancer is about 8%. This is a summary of the current situation based on latest data, although numbers are expected to grow as more people diagnosed with multiple myeloma die. There has been an increase in new diagnoses since the 1970s, probably partly due to improvements in detection. Better control of the disease may have also been responsible for better survival rates. Patients usually progress to a chronic form of the disease and have a limited lifespan." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"A high fraction of hospitalized [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) patients are receiving treatment that includes more than four chemotherapy regimens (mediastinal radiotherapy and proteasome inhibitors like bortezomib) and autologous stem cell transplantation for non-progressive disease. Although no therapies have proven effective for improving long-term progression-free survival in patients with myeloma, more than 60% of patients progress with disease in the 10 years following their first treatment." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"Currently no treatment for MM can cure the disease because it follows the paradigm that chronic malignancy is never cured and cannot be. However, a cure for MM is a realistic goal to which the MM community and clinical laboratories and investigators may be striving. New therapies should allow MM to become manageable rather than be the last manifestation of malignant transformation." - Anonymous Online Contributor

Unverified Answer

What does dexamethasone usually treat?

"The use of dexamethasone is now accepted in the United States as a standard treatment for patients with multiple myeloma refractory to treatment with ATRA alone and with anthracycline based chemotherapy.\n" - Anonymous Online Contributor

Unverified Answer

What is dexamethasone?

"Dexamethasone has been used in clinical trials to treat various conditions. It has many uses which include the following: (1) as part of chemotherapy; (2) in combination with methotrexate, 5-FU, vincristine, procarbazine and cyclophosphamide for the treatment of cutaneous T-cell lymphoma and non-Hodgkin lymphoma; and (3) in combination with cytotoxics, such as methotrexate, prednisone, vismodegib, and etoposide in patients with multiple myeloma who have failed standard chemotherapy." - Anonymous Online Contributor

Unverified Answer

How quickly does multiple myeloma spread?

"Although the clinical features of multiple myeloma and its spread are extremely variable, the disease behaves in a predictable fashion to a higher or lower degree in anyone." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of dexamethasone?

"Side effects of dexamethasone are common and include nausea, diarrhea, acne, hair loss, headache, muscle and joint swelling, muscle weakness or cramping, and hair color changes. There was no evidence of increased risk of osteoporosis or other side effects in multiple myeloma patients who had taken dexamethasone as part of chemotherapy. More research is needed to better understand the adverse effects of dexamethasone in multiple myeloma." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for multiple myeloma?

"Clinically appropriate patients who are eligible for a clinical trial should be counseled about trial enrollment and provided with the opportunity for an informed decision about treatment. To achieve the best-value clinical outcome, both clinical investigators and clinicians need to implement treatment according to the preferences of patients." - Anonymous Online Contributor

Unverified Answer

Is dexamethasone safe for people?

"DEX can be safely initiated and dosed over 6 months. Withdrawal is associated with a number of adverse events, of which most are reversible. DEX is a safer, more rapid and effective treatment for myeloma patients over steroids or IMI." - 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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