CLINICAL TRIAL

Lenalidomide for Multiple Myeloma

Waitlist Available · 18+ · All Sexes · Uniondale, NY

This study is evaluating whether maintenance therapy can help people who have been treated for myeloma.

See full description

About the trial for Multiple Myeloma

Eligible Conditions
Neoplasms, Plasma Cell · Plasma Cell Myeloma · Multiple Myeloma

Treatment Groups

This trial involves 2 different treatments. Lenalidomide 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.
Lenalidomide
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
Lenalidomide
FDA approved

Side Effect Profile for Phase 1 and Phase II: Event Free Survival and Overall Survival

Phase 1 and Phase II: Event Free Survival and Overall Survival
Show all side effects
Neutrophil count decreased
44%
Infusion related reaction
8%
Weakness
8%
Fever
6%
Fatigue
6%
Platelet count decreased
6%
Investigations - Other, specify
6%
Cardiac arrest
3%
Infections and infestations - Other, specify
3%
Left ventricular systolic dysfunction
3%
sepsis
3%
Atrial flutter
3%
Pleural effusion
3%
Chest pain
3%
Myocardial infarction
3%
Atrial fibrillation
3%
Renal and urinary disorders - Other, specify
3%
Hypokalemia
3%
Respiatory, thoracic and mediastinal disorders - Other, specify
3%
Respiratory Failure
3%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
3%
confusion
3%
Respiratory, thoracic and medicastinal disorders - Other, specify
3%
Abdominal Pain
3%
Nausea
3%
Injury, poisoning and procedural complications - Other, specify
3%
Acidosis
3%
Cough
3%
Encephalopathy
3%
Aortic valve disease
3%
Dysphagia
0%
Nervous system disorders - )ther, specify
0%
Ataxia
0%
White blood cell decreased
0%
Stroke
0%
Febrile neutropenia
0%
Vascular access complication
0%
Injury, poisoning and prcedural complications - Other, specify
0%
Cholecystitis
0%
Testicular pain
0%
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT01060384) in the Phase 1 and Phase II: Event Free Survival and Overall Survival ARM group. Side effects include: Neutrophil count decreased with 44%, Infusion related reaction with 8%, Weakness with 8%, Fever with 6%, Fatigue with 6%.

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:
Age ≥18 years. Because no dosing or adverse event data are currently available on the use of lenalidomide in patients <18 years of age, children are excluded from this study, but may be eligible for future pediatric trials
ECOG performance status ≤ 2
Creatinine clearance (CrCl) of greater than or equal to 40 mL/min. using the CKD-EPI formula (see Appendix C). If the CrCl based on the CKD-EPI formula is <40 mL/min, the patient will have a 24 hr urine collection to measure CrCl. The measured CrCl must also be ≥ 40 ml/min.
All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
View All
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
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 5 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 Lenalidomide will improve 1 primary outcome in patients with Multiple Myeloma. Measurement will happen over the course of 5 years.

progression-free survival
5 YEARS
PFS is defined as time of start of treatment to time of progression or death, whichever occurs first.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does multiple myeloma run in families?

This family highlights the familial nature of myeloma. All three familial cases investigated herein had at least one affected sibling with MM. The detection of mutations in BRCA1 and BRCA2 in two of these cases suggests that BRCA may play a role in certain cases of myeloma. However, we were unable to identify the causal gene in any of the three cases.

Anonymous Patient Answer

Can multiple myeloma be cured?

The data do not support the general claim that [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) can be cured, nor the claim of specific cures for any specific subtype of myeloma.

Anonymous Patient Answer

What causes multiple myeloma?

Most of the cases of multiple myeloma were found in patients with prior light to moderate drinking of alcoholic beverages, while cigarette smoking was the most important factor associated with multiple myeloma.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

Common treatment options for MM include standard therapies and clinical trials. In all, the 5-year survival rate for untreated MM is approximately 30%, meaning that some patients with MM seek out therapies specifically designed for their disease and the type of therapy they choose. While some patients choose to pursue different forms of treatment, including chemotherapy, steroids, or new biological strategies, others prefer standard approaches. Future research in this area should focus on more effective approaches to the treatment of MM, which would improve the survival rate, allowing patients to live longer and be more likely to pursue therapeutic approaches that would maximize their response to treatment and minimize their number of adverse effects. This article is protected by copyright. All rights reserved.

Anonymous Patient Answer

What are the signs of multiple myeloma?

The diagnosis of multiple myeloma is based on clinical and laboratory findings. The presence of anemia, increased serum IgM production, osteolytic lesions, renal osteodystrophy and bone pain are indicative of a multiple myeloma diagnosis. The presence of a solitary plasmacytoma of bone is a diagnostic challenge.

Anonymous Patient Answer

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

About 19.8 million Medicare beneficiaries have been diagnosed with [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) in 1998. This makes up 3.5% of all Medicare beneficiaries and one sixth of multiple myeloma in the U. S. In 2000, 1.6 million patients were living with myeloma. In 2003, Medicare beneficiaries with multiple myeloma were estimated to use nearly $1 billion of medical services. Data from a recent study are consistent with the results of earlier studies showing high annual incidence rates of multiple myeloma in the U. S. compared with most of the developed world.

Anonymous Patient Answer

What is multiple myeloma?

Multiple myeloma is a cancer that forms mainly in the bone marrow. The bone marrow is the site of formation for all plasma cells which leads to the formation of all symptomatic plasma cell neoplasms including multiple myeloma. It is the deadliest hematologic cancer and is estimated to affect more than 20,000 people in the United States. Multiple myeloma is considered to be underdiagnosed due to its heterogeneity and late stage of development. It is a disease with high morbidity and mortality and an increasing incidence rate. Multiple myeloma causes one of the highest fatality rates of any cancer in the United States.

Anonymous Patient Answer

Who should consider clinical trials for multiple myeloma?

Patients, their family members, physicians and patients are important partners to consider when designing and conducting clinical trial research. Patients are frequently not informed about potential risks, and they may not be willing to commit to an experimental treatment that could not affect their health status in any way. Physicians’ perspectives are often constrained by the burden of time, costs, and institutional priorities, and by a lack of scientific evidence for an intervention. Research shows the value of shared decision-making between patients and their healthcare providers to prevent potential trial non-adherence and to improve participants’ overall satisfaction with treatment. Clinicians also need educational materials addressing patients’ specific needs (e.g.

Anonymous Patient Answer

How quickly does multiple myeloma spread?

The early stages of primary MM progression are often undiagnosed, and thus there may be some cases of early staging of MM and improved outcomes from therapy. However, early MM progression is also typically a gradual process and patients often have advanced disease requiring intensive therapy.

Anonymous Patient Answer

Have there been other clinical trials involving lenalidomide?

We summarize the clinical trials completed on patients with MM using lenalidomide. These studies indicate that lenalidomide has shown some efficacy as previously reported. However, the optimal duration of lenalidomide treatment has yet to be defined.

Anonymous Patient Answer

What is the primary cause of multiple myeloma?

The primary cause of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) is a (relatively) genetic abnormality of the cells of the [bone marrow], called monoclonal gammopathy. In the first few years of multiple myeloma, the [leukemia cells of the myeloma proliferate without being killed or stopped, thus the [clonal plasma cells of multiple myeloma are produced inside blood and bone marrow]; they stay in the bone marrow, and in bone marrow [smear] smears, [leukocytes are visible].

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Multiple Myeloma by sharing your contact details with the study coordinator.