Dexamethasone for Neoplasms, Plasma Cell

Phase-Based Estimates
1
Effectiveness
2
Safety
John Theurer Cancer Center-Hackensack Meridian Health, Hackensack, NJ
Neoplasms, Plasma Cell+1 More
Dexamethasone - Drug
Eligibility
18+
All Sexes
Eligible conditions
Neoplasms, Plasma Cell

Study Summary

This study is evaluating whether a combination of drugs can improve the survival of people with multiple myeloma.

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Eligible Conditions

  • Neoplasms, Plasma Cell
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Dexamethasone will improve 1 primary outcome, 4 secondary outcomes, and 5 other outcomes in patients with Neoplasms, Plasma Cell. Measurement will happen over the course of Time from Day 0 (transplant) and date of enrollment to study completion (through 12 weeks) by investigator assessment..

12 Months
Progression free survival (PFS)
Day 90
Safety and tolerability of pembrolizumab (MK-3475), lenalidomide and dexamethasone following ASCT.
Week 15
Comparison in bone marrow aspirates of the extent of pre-pembrolizumab (MK-3475), lenalidomide and dexamethasone PD-L1 expression and change from baseline PD-L1 expression in responders versus non-responders
Week 12
Evaluation of stringent complete response, complete response, and very good partial response rate (sCR + CR + VGPR rate)
Week 12
Duration of Response (DOR)
Week 12
Assessment of T cell repertoire in bone marrow aspirates and peripheral blood samples.
Assessment of immune phenotype in bone marrow aspirates and peripheral blood samples and plasma cytokines.
Assessment of plasma cytokines
Day 90
Identification and assessment of specific intestinal microbial strains (via stool specimens) associated with improved outcome in autologous stem cell transplantation patients treated with PEM+LEN+DEX compared to PEM+LEN.
Week 12
Time to Progression (TTP)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Pembrolizumab + lenalidomide

This trial requires 16 total participants across 2 different 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.

Pembrolizumab + lenalidomideThis is an open label study. Pembrolizumab 200 mg IV every 3 weeks and lenalidomide 25 mg po daily x 14 days and dexamethasone 40 mg po once weekly for a 21-day cycle x 2 cycles. This is followed by pembrolizumab 200 mg every 3 weeks and lenalidomide 25 mg po daily x 14 days for a 21-day cycle x 2 cycles for a total of 4 cycles.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Lenalidomide
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

John Theurer Cancer Center-Hackensack Meridian Health - Hackensack, NJ

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:
International Staging System (ISS) stage 3 (See Appendix 3 for ISS Staging), and/or Deletion 13q by cytogenetics, and/or 1q amplification, 1p deletion, p53 deletions (17p deletions), t(4;14), t(14;16), t(14;20), hypodiploidy, and/or High-risk gene expression profile (GEP) scores
Be able to provide a newly obtained bone marrow aspirate/biopsy material for biomarker analysis and disease assessment.
Have a performance status of ≤2 on the ECOG Performance Scale (See Appendix 4).
Be willing and able to provide written informed consent/assent for the trial.
Be 18 years of age on day of signing informed consent.
Has a confirmed diagnosis of MM based on standard criteria. (See Appendix 2 for MM Diagnostic Criteria.)
Is between 60 and 180 days from peripheral blood autologous stem cell transplant.
A monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g/dL and/or Urine monoclonal levels of at least 200 mg/24 hours
For subjects without measurable serum and urine M-protein levels, an abnormal free light chain (FLC) ratio (normal value 0.26 - 1.65) with involved FLC ≥10 mg/dL
Radiographic evidence of disease for those without measurable M-spike or free light chains.

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 neoplasms, plasma cell?

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Neoplasms, plasma cell is one of the peripheral forms of multiple myeloma but it can be found in other plasma cell-related diseases as well. The plasma cells often form multiple myeloma-like disease without causing pain or anemia but they may grow in the bone marrow. Differential diagnosis is required because treatment for plasma cell dysplasias usually is different from multiple myeloma.

Unverified Answer

What causes neoplasms, plasma cell?

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The plasma cell is the most frequently involved myeloid neoplasms group in BMACs, which, due to its aggressive biological behavior are associated with high morbidity and mortality. Neoplasms of plasma cell are usually asymptomatic. Patients presenting with plasmacytomas are mostly non-secretory, elderly males, whose prognosis is generally unfavorable, even if treated locally with radiation therapy.

Unverified Answer

Can neoplasms, plasma cell be cured?

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CML is [a progressive disorder] and so its progress toward complete remission in patients with high initial CML numbers cannot be confirmed in a randomized, single-arm trial. However, patients with low initial CML numbers might benefit from the administration of high-dose [Imatinib mesylate, Novartis, Groupe Octexa]http://www.nhs.uk/conditions/cancer/oncology/malignant-tumours/diagnosis/cmo_index/cmo/cmo-index_view.aspx. answer: CML therapy is a treatment option for patients with CML and may possibly represent a cure.

Unverified Answer

What are common treatments for neoplasms, plasma cell?

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In neoplasms, plasma cell-directed therapies have the best survival rate for the patient; the patients' own immunity is expected to control the disease more effectively. The survival rates and duration of treatment are longest for elderly neoplasm patients, those with multiple and/or early distant metastases, and those who are able to control their disease (e.g., with minimal residual disease after treatment). The survival rate of plasma cell disease increases significantly with the increase of the number of treatment cycles and treatment duration for one neoplasm. The risk of experiencing severe side effects or death increase with the duration of treatment for multiple neoplasms.

Unverified Answer

What are the signs of neoplasms, plasma cell?

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The signs of PCL include bone pain, an increased sedimentation rate and enlargement of osseous lesions on radiographs. These signals may become more obvious as the disease advances and become more and more severe. The disease may also cause severe spinal stenosis. Increased sedimentation rate may suggest a greater presence of tumor-related bone lesions.

Unverified Answer

How many people get neoplasms, plasma cell a year in the United States?

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Although neoplasms and plasma cell-associated neoplasms are the two most common reasons for visits to hospitals, the current data are insufficient to determine their relative frequency during the year in the USA. This problem will be resolved with improved clinical information of neoplasms and plasma cell disorders.

Unverified Answer

What does dexamethasone usually treat?

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In contrast to a recent study, we were not able to prove dexamethasone's effectiveness as an immune-modulatory drug in malignant and benign tumor patients. We conclude that in clinical settings there is still a lack of evidence concerning dexamethasone's biological activity.

Unverified Answer

How quickly does neoplasms, plasma cell spread?

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The rapid appearance of neoplasms in the initial stages of cancer evolution might indicate the existence of a very rapidly proliferating population. Alternatively, this rapid growth may be caused by the presence in the plasma cell population of neoplasms. However, these data may be explained by neoplasms or plasma cells as cellular precursors for secondary malignancies.

Unverified Answer

What is the average age someone gets neoplasms, plasma cell?

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Neoplasms and plasma cell typically present between 40-60 years old in the UK [NCCN guidelines-2018, UK cancer patient's organization-2019]. [Read more on average age of neoplasms, plasma cell in UK]

Unverified Answer

Does dexamethasone improve quality of life for those with neoplasms, plasma cell?

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Dexamethasone was not associated with better quality of life in those with plasma cell neoplasms. However, patient preferences suggest improvement in QOL with dexamethasone. The role of dexamethasone in the treatment of multiple myeloma needs further study.

Unverified Answer

Is dexamethasone typically used in combination with any other treatments?

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In the authors' experience, dexamethasone added to other existing therapies is often used in the treatment of multiple myeloma when patients are initially ineligible to be treated with thalidomide alone or are not responding adequately to thalidomide.

Unverified Answer

What are the common side effects of dexamethasone?

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Dexamethasone was used in about 14% of patients in this population, and its common side effects accounted for 42.9% of side effects reported. Most side effects were mild or moderate.

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