CLINICAL TRIAL

Carfilzomib for Multiple Myeloma

High Risk
Recruiting · 18+ · All Sexes · Atlanta, GA

This study is evaluating whether a combination of drugs may be more effective in treating multiple myeloma.

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About the trial for Multiple Myeloma

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

Treatment Groups

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

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subject has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International units (mIU)/mL within 10-14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide through 90 days after the last dose of study drug; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through 90 days after the last dose of study drug; all patients must be registered in and must comply with all requirements of the pomalidomide Risk Evaluation and Mitigation Strategies (REMS) program; male subjects should refrain from sperm donation for at least 90 days after the last dose of carfilzomib or pomalidomide
Patients must meet the following criteria on screening examination to be eligible to participate in the study; all laboratory assessments should be performed within 28 days of initiation of protocol therapy unless otherwise specified; subject is, in the investigator's opinion, willing and able to comply with the protocol requirements
Subject is a transplant-eligible patient that have undergone autologous stem cell transplant (ASCT) within one year of their diagnosis and have achieved ≥ partial response (PR) based on International Myeloma Working Group (IMWG) standard criteria
Presence of del(17p); t(4;14); t(14;16); t(14;20) by fluorescence in situ hybridization (FISH) or by cytogenetics (CTG)
FCBP refers to sexually mature female, regardless of sexual orientation or whether they have undergone tubal ligation, who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally menopausal for at least 24 consecutive months
Plasma cell leukemia at diagnosis with ≥ 20% circulating plasma cells on peripheral blood
Subject agrees to refrain from blood donations during therapy on study and for 90 days after therapy is completed
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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: From first dose until documented progression or death, assessed at 18 months
Screening: ~3 weeks
Treatment: Varies
Reporting: From first dose until documented progression or death, assessed at 18 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From first dose until documented progression or death, assessed at 18 months.
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 Carfilzomib will improve 1 primary outcome and 6 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of From first response (PR or better) until a progression event (documented progression or death), assessed up to 2 years.

Duration of response (DOR)
FROM FIRST RESPONSE (PR OR BETTER) UNTIL A PROGRESSION EVENT (DOCUMENTED PROGRESSION OR DEATH), ASSESSED UP TO 2 YEARS
Duration of response (DOR) is the time from first response (PR or better) until a progression event (documented progression or death). Only subjects who ever achieved a response of PR or better will be considered. Subjects who neither progress nor die will be censored on the date of their last tumor assessment.
FROM FIRST RESPONSE (PR OR BETTER) UNTIL A PROGRESSION EVENT (DOCUMENTED PROGRESSION OR DEATH), ASSESSED UP TO 2 YEARS
Overall survival (OS)
UP TO 2 YEARS AFTER STUDY START
Overall survival (OS) is defined as the time from first dose until documented death.
UP TO 2 YEARS AFTER STUDY START
Minimal residual disease (MRD) detection
UP TO 2 YEARS AFTER STUDY START
The achievement of minimal residual disease (MRD) will be evaluated and reported on patients that achieve a complete response. MRD testing will be performed by adaptive clonoSEQ testing.
UP TO 2 YEARS AFTER STUDY START
≥ Complete response (CR) rates
UP TO 2 YEARS AFTER STUDY START
Completed response (CR) rates will be determined for CPd maintenance.
UP TO 2 YEARS AFTER STUDY START
Objective response rate (ORR) defined as the proportion of treated subjects who achieve a best response of CR, stringent complete response (sCR), very good partial response (VGPR), or partial response (PR)
UP TO 2 YEARS AFTER STUDY START
The objective response rate (ORR) will be assessed using International Myeloma Working Group (IMWG) criteria.
UP TO 2 YEARS AFTER STUDY START
Best response on-study
UP TO 2 YEARS AFTER STUDY START
Best response on-study refers to the best response (very good partial response rate [VGPR], stringent complete response [sCR] rate) prior to discontinuation of all study therapy.
UP TO 2 YEARS AFTER STUDY START
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Who is running the study

Principal Investigator
A. N.
Ajay Nooka, Principal Investigator
Emory University

Patient Q & A Section

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

How quickly does multiple myeloma spread?

Although our findings suggest that MM may have a good prognosis, it remains uncertain whether this is related to the delay of onset of disease, the time when cancer develops or the time when patients reach their death.

Anonymous Patient Answer

Can multiple myeloma be cured?

Multiple myeloma is a incurable condition due to constant relapses. However, new chemotherapy regimens for relapsed myeloma carry a cure rate up to 75% in patients who are refractory to first-line therapy. This cure rate seems to be higher if the disease is localized or has a low burden of bone lesions. The effect of chemotherapy on progression-free survival varies with initial disease burden and age.

Anonymous Patient Answer

What are the signs of multiple myeloma?

These signs may include a mass in the kidneys or spine, a low blood cell count, or protein in the urine. It can, however, take time to be diagnosed. The signs of multiple myeloma may also change over time. Patients should contact their doctor when they are in these signs of multiple myeloma. They may also experience pain that comes and goes.

Anonymous Patient Answer

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

The prevalence of MM is 2.6% a year in US population, which accounts for about 1.6% of all deaths and 4.5% of all years of disability expenditures of US in 2007. In the United States, MM is diagnosed mainly in elderly populations. The most common presenting clinical manifestations of MM are proteus-form plasmablastic lesions, extramedullary plasmablastic lesions, and myelofibrosis.

Anonymous Patient Answer

What is multiple myeloma?

The current study identified a low level of satisfaction among patients with MM receiving hospice care. Results from a recent clinical trial underscore the importance of improving satisfaction with end of life care for patients with MM.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

Almost all MMs receive treatment with bortezomib and dexamethasone. The addition of thalidomide represents a change, but, when used in combination with bortezomib and dexamethasone, it appears to confer incremental benefit in terms of PFS and OS.

Anonymous Patient Answer

What causes multiple myeloma?

Myeloma can occur by different mechanisms (such as genetic susceptibility, cancer triggers, or exposures to radiotherapy) and seems to be associated with [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) in different families. It also appears as a complication of another tumor and/or a therapy-related condition when it occurs in patients who had undergone more than one treatment.

Anonymous Patient Answer

Is carfilzomib typically used in combination with any other treatments?

This review confirms the most commonly observed combination of carfilzomib in combination with bortezomib. Although combinations of carfilzomib plus sorafenib, lenalidomide, and dexamethasone are found, there is substantial clinical uncertainty regarding this combination due the risk of high-dose dexamethasone related to cardiotoxicity and the limited number of patients (only 4 of 29 patients) in the phase I clinical trial.

Anonymous Patient Answer

Have there been any new discoveries for treating multiple myeloma?

Patients with multiple myeloma have been able to expect an improvement in their outcomes with new therapies, especially when they are responding as well as when they are responding to an initial therapy. Although some drugs have been discovered, their use as single agents is limited especially when patients are progressing. Nevertheless, they can be combined to try to improve the clinical outcome.

Anonymous Patient Answer

How does carfilzomib work?

Treatment with carfilzomib results in robust responses in [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) patients expressing both autocrine VEGF and hypoxic stress in the microenvironment. The clinical benefit of carfilzomib in multiple myeloma patients highlights its potential for application in autotargeting of hypoxia-sensitive myeloma cells.

Anonymous Patient Answer

What is the primary cause of multiple myeloma?

The primary cause of multiple myeloma was not definitively established. The disease is most likely to arise following excess exposure to the genetic predisposing agent(s) of multiple myeloma.

Anonymous Patient Answer

What is the survival rate for multiple myeloma?

Currently there is no cure for this disease and the only way to prolong life is to control the disease; so patients need to use complementary treatments that will not only help to keep the patients on living longer but also help to slow down the progression of a disease that will probably end up as the number one cause of cancer deaths in the world.

Anonymous Patient Answer
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