CLINICAL TRIAL

Pomalidomide for Multiple Myeloma

1 Prior Treatment
Refractory
Relapsed
Waitlist Available · 18+ · All Sexes · Atlanta, GA

Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma

See full description

About the trial for Multiple Myeloma

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

Treatment Groups

This trial involves 2 different treatments. Pomalidomide 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.
Pomalidomide
DRUG
Elotuzumab
DRUG
Dexamethasone
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
Pomalidomide
FDA approved
Elotuzumab
FDA approved
Dexamethasone
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment 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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person had multiple myeloma and received a stem cell transplant as the first line of treatment show original
Repeated failure of one or two lines of treatment for multiple myeloma is classified as a treatment failure show original
The person received between two and six cycles of induction therapy prior to their second autologous stem cell transplant. show original
The patient has been diagnosed with multiple myeloma based on their histology. show original
The individual received standard of care melphalan conditioning for a 2nd autologous stem cell transplantation, and is currently Day +80 to +120 following the transplant show original
All US study participants must be registered into the mandatory POMALYST REMS® program and be willing and able to comply with the requirements of the POMALYST REMS® program. For Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
Females of reproductive potential within the US must agree to adhere to the scheduled pregnancy testing as required in the POMALYST REMS® program. For Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
must be 18 or older, no older than 75. show original
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
This means that the absolute neutrophil count is at least 1000 per cubic millimeter. show original
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: Up to 5 years post completion of treatment
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years post completion of treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years post completion of treatment.
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 Pomalidomide will improve 1 primary outcome and 6 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Through completion of treatment (estimated to be 102 weeks).

Complete response rate (CRR)
THROUGH COMPLETION OF TREATMENT (ESTIMATED TO BE 102 WEEKS)
Complete response rate (CRR) will be defined as the proportion of evaluable patients meeting the criteria complete (CR) or stringent complete response (sCR) Stringent complete response (sCR) requires all of the following: CR as defined below Normal free light chain ratio (0.26-1.65) Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence Complete response (CR) requires all of the following: Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine If serum and urine monoclonal protein are unmeasurable, Normal free light chain ratio (0.26-1.65) <5% plasma cells in the bone marrow Disappearance of soft tissue plasmacytoma Patients who do not meet the definition of CR based solely on residual monoclonal protein on serum electrophoresis and/or immunofixation, but are MRD-negative as described above, will also be considered CR.
THROUGH COMPLETION OF TREATMENT (ESTIMATED TO BE 102 WEEKS)
Overall response rate (ORR)
THROUGH COMPLETION OF TREATMENT (ESTIMATED TO BE 102 WEEKS)
-Overall response rate (ORR) will be defined as the proportion of evaluable patients meeting the criteria for partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR).
THROUGH COMPLETION OF TREATMENT (ESTIMATED TO BE 102 WEEKS)
Toxicity of regimen as measured by frequency of adverse events per the number of participants treated
UP TO 30 DAYS FOLLOWING COMPLETION OF TREATMENT (ESTIMATED TO BE 106 WEEKS)
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
UP TO 30 DAYS FOLLOWING COMPLETION OF TREATMENT (ESTIMATED TO BE 106 WEEKS)
Event-free survival (EFS) rate
1 YEAR
-Event-free survival (EFS) will be defined as time from ASCT to disease progression, relapse, or death, whichever occurs first. Patients who are removed from study therapy prior to any of these events occurring will be censored at the time of initiation of subsequent anti-myeloma treatment.
1 YEAR
Event-free survival (EFS)
UP TO 5 YEARS POST COMPLETION OF TREATMENT
-Event-free survival (EFS) will be defined as time from ASCT to disease progression, relapse, or death, whichever occurs first. Patients who are removed from study therapy prior to any of these events occurring will be censored at the time of initiation of subsequent anti-myeloma treatment.
UP TO 5 YEARS POST COMPLETION OF TREATMENT
Overall survival (OS)
UP TO 5 YEARS POST COMPLETION OF TREATMENT
-Overall survival (OS) will be defined as time from ASCT to death due to any causes. Patients who are alive at the time of data analyses will be censored on the last known alive date. Patients who are removed from study therapy prior death will be censored at the time of initiation of subsequent anti-myeloma treatment.
UP TO 5 YEARS POST COMPLETION OF TREATMENT
See More

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?

The clinical presentation of MM is not always typical of MM, but may be very similar to the presentation of AL, DLBCL, and CLL. Thus, the presence of anemia, low blood cell levels, severe anemia and hypercalcemia should raise suspicion of MM. As

Anonymous Patient Answer

What are common treatments for multiple myeloma?

A small percentage of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) patients are eligible for myeloma-targeted therapies, a novel and highly active treatment strategy for multiple myeloma patients undergoing an operation. Patients enrolled in the trial showed survival rates and progression-free survival rates comparable to historically treated patients. ClinicalTRACT Number: NCT00016256 \n

Anonymous Patient Answer

What causes multiple myeloma?

MM is unlikely to be caused by any one factor. Rather, it is probably the result of a complex interaction of risk and protective factors. While we know some of these factors, we lack an understanding of the mechanism by which they operate. The challenge for the future may be to develop an integrated risk score with greater predictive accuracy than that of any current model. Only when such a risk score proves useful in the clinical management of a particular individual patient with MM will it be possible to recommend specific preventive or therapeutic measures that will reduce the likelihood of its clinical progression.

Anonymous Patient Answer

Can multiple myeloma be cured?

The goal of MM treatment is a cure. With MM's low survival and remissions with MM therapies, it is no longer an appropriate goal to cure MM. More emphasis needs to be placed on long-term disease-free survival and improving MM remission rates.

Anonymous Patient Answer

What is multiple myeloma?

Multiple myeloma is a rare and usually curable leukemia that originates in plasma cells of bone marrow. The disease is characterized by elevated levels of serum paraprotein and hypercalcemia. Many newly diagnosed MM patients present to oncologists with a newly diagnosed bone pain and/or pathological fracture. The management of MM currently involves use of chemotherapy regimens that do not cure MM; however, some studies show improvement in quality of life.

Anonymous Patient Answer

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

Although less common than AL, IM and MM are a growing and serious clinical problem in the United States. Because of the recent increase in the incidence, incidence is the most important and reliable measure for evaluating the prevalence of MM in a given area.

Anonymous Patient Answer

What is the survival rate for multiple myeloma?

Although the [median survival following the initiation of a bortezomib-containing regimen is around 10 months and has been shown to be effective in trials] is not as strong as previous estimates, this study demonstrates that patients may expect to survive longer than the 10 months that are typical after [bortezomib-based regimens] have been initiated. The survival rate for patients in this investigation is currently the best known survival estimate for MM patients who have been treated with a bortezomib-containing regimen (bortezomib plus dexamethasone or lenalidomide plus dexamethasone).

Anonymous Patient Answer

How quickly does multiple myeloma spread?

The time between first diagnosis and a subsequent relapse is relatively short in myelomas (8.0-10.6 months) and, in half of cases, in a third of patients with low bone destruction disease a disease-free interval seems to be achievable after a period of less than 6 months. Thus, the time between diagnosis and first observation of myeloma related events is rather short and this does not seem to be explained by the time between initial diagnosis and observation of an event. Further studies on myeloma pathogenesis are necessary to find the reasons that myeloma patients relapse.

Anonymous Patient Answer

Have there been other clinical trials involving pomalidomide?

We found limited evidence that pomalidomide has been studied in other clinical trials as compared to the current clinical trial, and it has not been found in clinical trials that could be accessed by patient/physician.

Anonymous Patient Answer

What are the chances of developing multiple myeloma?

In our study population, the risk of developing multiple myeloma in the 3-to-4-year time interval preceding and following a diagnosis of monoclonal gammopathy of undetermined significance/smoldering multiple myeloma in the United States was 0.12% and 0.02%, respectively. However, no patient in this study had the typical clinical features of monoclonal gammopathy, thus, these patients likely had occult primary multiple myeloma.

Anonymous Patient Answer

Has pomalidomide proven to be more effective than a placebo?

The study clearly showed that pomalidomide is significantly more effective and well tolerated than a placebo. However, we are also sure that the differences in the outcome could be due to the placebo effect.

Anonymous Patient Answer

What does pomalidomide usually treat?

Pomalidomide can be used for multiple indications, and when used to treat more serious, chemotherapy-refractory MDS it can benefit patients with multiple myeloma. It should be used with caution in patients with lymphomas, who are at risk of developing blood clots.

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.