CLINICAL TRIAL

Discontinuation Phase for Multiple Myeloma

Recruiting · 18+ · All Sexes · Chicago, IL

Study to Assess for Measurable Residual Disease (MRD) in Multiple Myeloma Patients

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About the trial for Multiple Myeloma

Eligible Conditions
Multiple Myeloma · Neoplasms, Plasma Cell

Treatment Groups

This trial involves 2 different treatments. Discontinuation Phase 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Discontinuation Phase
DEVICE
Screening Phase
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

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:
ECOG performance status less than or equal to 2 (Karnofsky > 60%)
Males and females > 18 years of age
Patients must have achieved a CR (CR) by IMWG consensus response criteria. For patients with a persistent low level paraprotein ('M-spike'), mass spectrometry may be used to determine if the paraprotein is significant or not. Results of mass spectrometry may be used to supercede results of serum protein electrophoresis.
Patients with a diagnosis of multiple myeloma who have undergone initial treatment, with or without autologous stem cell transplant, and currently treated with single-agent maintenance therapy (lenalidomide, pomalidomide, bortezomib, daratumumab, or ixazomib) for a duration of at least 1 year. The 1 year duration can include time spent receiving at least 8 cycles of doublet or triplet induction regimens OR multi-agent post-transplant maintenance prior to conversion to single agent maintenance therapy.
Patients must have had their most recent bone marrow testing within the last 2 years and negative for MRD by flow cytometry (with a sensitivity of at least 10-5) or by NGS with a sensitivity of at least 10-5.
Patients must have a most recent PET/CT within the last 1.5 years without evidence of myeloma disease.
Must have baseline bone marrow sample that can be used for clonality identification for NGS and mass spectrometry if not already performed.
Willing and able to undergo a bone marrow biopsy and aspiration.
Ability to understand and the willingness to sign a written informed consent document.
Females of childbearing potential (FCBP) must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) if continued on lenalidomide as part of standard of care and 2) for at least 28 days after discontinuation of lenalidomide
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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: 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 years.
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 Discontinuation Phase will improve 3 primary outcomes and 2 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 3 years.

Median Progression Free Survival rate
3 YEARS
Assess progression free survival of double MRD-negative (1 in 1,000,000 cells negative/1 in 10,000,000 cells negative) patients and of the 1 in 1,000,000 cells negative/1 in 10,000,000 cells positive patients who have discontinued maintenance therapy
3 YEARS
Median overall survival rate
3 YEARS
Assess overall survival of double MRD-negative (1 in 1,000,000 cells negative/1 in 10,000,000 cells negative) patients and of the 1 in 1,000,000 cells negative/1 in 10,000,000 cells positive patients who have discontinued maintenance therapy.
3 YEARS
Determine the MRD conversion rate
3 YEARS
Determine the MRD conversion rate from 1 in 1,000,000 cells and 1 in 10,000,000 cells negative to positive after discontinuation of maintenance therapy.
3 YEARS
Determine the difference in MRD detection by NGS
3 YEARS
Determine the difference in MRD detection by NGS in the bone marrow at depths of 1 in 1,000,000 cells and 1 in 10,000,000 cells.
3 YEARS
NGS-based Minimal Residual Disease testing determined by the ClonoSeq assay
3 YEARS
Determine the feasibility of performing NGS-based MRD testing of bone marrow aspirate samples that have undergone CD138+ immunomagnetic cell separation (i.e. 1 in 10,000,000 cells depth) will be determined by the rate of achieving 20 million cells in raw aspirate sample with a sufficient DNA for analysis as determined by the ClonoSeq assay.
3 YEARS

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?

Most of the signs of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) appear before 20 years of age, while those of light chains myeloma most often appear later. Some of the signs of multiple myeloma appeared early in our patients, indicating that the disease is not as rare as is usually reported. The role of imaging in the diagnostic of multiple myeloma is not yet fully understood, but there are signs of disease in MRI, especially Bence Jones proteinemia and a lytic lesion on skeletal radiography. However, the role of imaging for multiple myeloma in symptomatic disease is much more challenging, with no definitive conclusions.

Anonymous Patient Answer

What causes multiple myeloma?

The primary cause of multiple myeloma is a combination of genetic abnormalities and environmental exposures. Genetic changes appear early in the course of the disease and may also play a role in the development of multiple myeloma. Many genetic changes are not known, but when they are found, they tend to appear early in the disease. Environmental exposures that worsen multiple myeloma are the primary risk factor, but genetic alterations must interact with environmental factors to develop multiple myeloma. The risk factors and the timing of development of multiple myeloma remains unknown.

Anonymous Patient Answer

Can multiple myeloma be cured?

Patients treated with a highly standardized plan of care and who attained a nadir of <5 g/dL had no evidence of progression at 3 years. However, survival was better when compared to patients treated with more conventional regimens.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

A wide variety of treatments are used to treat patients with multiple myeloma. Common options include high-dose alkylation and stem cell [transplant](https://www.withpower.com/clinical-trials/transplant)ation; thalidomide, lenalidomide, autologous stem cell transplantation, chemotherapy, autologous stem cell transplantation, immunotherapy, and radiation therapy; allogeneic stem cell transplantation, bone marrow transplantation, high-dose chemotherapy, stem cell transplantation, and chemoimmunotherapy; and targeted therapies, such as protease inhibitors, receptor tyrosine kinase inhibitors, or immunomodulators. Because of the high mortality of patients with multiple myeloma, ongoing research has been aimed at a deeper understanding of the disease.

Anonymous Patient Answer

What is multiple myeloma?

MM is a type of cancer in which the bone marrow is invaded and cloned by abnormal plasma cells. MM is more common in older, heavier individuals, is associated with high levels of light chains, and tends to recur more often and progress more rapidly. While the disease is treatable, a cure has not been found. This myeloma is not the same disease, however, that is mentioned in the title of the book. The name is a reference to the multiple occurrences of the same cancer in the body.

Anonymous Patient Answer

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

5% of both men and women in the USA were diagnosed with this disease in 2012; this translates to about 37.6 new cases per million each year. Although multiple myeloma has the highest survival of all hematologic malignancies, about one third of people are diagnosed at a stage where treatment is not possible.

Anonymous Patient Answer

How quickly does multiple myeloma spread?

Data from a recent study of our study demonstrate a significant differences in DFS and OS of MM patients. The prognosis varies between the patients with the presence or absence of SPn or SPn+LN and the DFS values are higher in both groups in comparison to the patients with the absence of LN.

Anonymous Patient Answer

What are the latest developments in discontinuation phase for therapeutic use?

This is an important development as it is likely to provide the first evidence of the real-world use of newer agents, as reflected in the FDA review of the therapeutic use of Rituximab. The impact of such new drug developments will be the subject of a further article.

Anonymous Patient Answer

What is the primary cause of multiple myeloma?

The association of multiple myeloma with a known causal gene suggests that a genetic predisposition may be an important factor in the etiology of multiple myeloma. A genetic basis for multiple myeloma should be recognized in future translational studies.

Anonymous Patient Answer

Does discontinuation phase improve quality of life for those with multiple myeloma?

In the long run, HRQoL for this group improved and those who completed induction and discontinuation achieved HRQoL that was equal to, or superior to, that of the general population. This suggests that clinicians might be able to reduce treatment burden and, as a result, the risk of toxicity.

Anonymous Patient Answer

What does discontinuation phase usually treat?

In our experience, CBT (the discontinuation regimen used in the MMM2016 trial, as well as in the earlier trials used to establish CBT's efficacy, e.g. CALGB 80303 and CALGB 006) is beneficial in MMM patients.

Anonymous Patient Answer

Have there been any new discoveries for treating multiple myeloma?

No cures have been found for multiple myeloma, but recent therapies have improved survival rates and prevented further bone destruction. Current standard treatment regimens often produce disease stabilization or even remission as well as a very good response to treatment in most people with multiple myeloma. Further improvements can come from discovering new therapeutic regimens and using treatment strategies that can extend OS and minimize cumulative toxicities. Future research may also benefit from better understanding the molecular pathways that define response and treatment outcome and the development of new drugs to target these pathways. Today there are many researchers involved in multiple myeloma research, but unfortunately advances in the treatment and understanding of the disease have been slow to emerge.

Anonymous Patient Answer
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