180 Participants Needed

Carfilzomib + Lenalidomide + Dexamethasone for Multiple Myeloma

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Chicago
Must be taking: Lenalidomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 3 randomized trial of carfilzomib, lenalidomide, dexamethasone versus lenalidomide alone after stem-cell transplant for multiple myeloma, eligible to subjects who completed autologous stem cell transplant for symptomatic myeloma who are considered for lenalidomide maintenance.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is the combination of Carfilzomib, Lenalidomide, and Dexamethasone safe for humans?

Carfilzomib has been associated with heart and lung-related side effects, as shown in studies like the ASPIRE and ENDEAVOUR trials. Lenalidomide has a predictable safety profile, but it can cause serious side effects in some patients, such as infections and other non-blood-related issues. It's important to discuss these potential risks with your doctor to understand how they might apply to you.12345

What makes the drug combination of Carfilzomib, Lenalidomide, and Dexamethasone unique for treating multiple myeloma?

This drug combination is unique because it includes Carfilzomib, a proteasome inhibitor that works by blocking the protein complex responsible for breaking down proteins in cells, leading to cancer cell death. It has shown significant improvement in progression-free survival for patients with relapsed multiple myeloma compared to Lenalidomide and Dexamethasone alone, although it did not show superior results for newly diagnosed patients compared to the standard treatment.678910

What data supports the effectiveness of the drug combination Carfilzomib, Lenalidomide, and Dexamethasone for treating multiple myeloma?

Research shows that the combination of Carfilzomib, Lenalidomide, and Dexamethasone significantly improved progression-free survival in patients with relapsed multiple myeloma, providing an additional 8.7 months without disease progression compared to Lenalidomide and Dexamethasone alone.6781011

Who Is on the Research Team?

Andrzej Jakubowiak, MD, PhD - UChicago ...

Andrzej Jakubowiak, MD, PhD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

Adults over 18 with multiple myeloma who've had a stem-cell transplant can join this trial. They should be in good health, have stable disease post-transplant, and agree to birth control measures if applicable. Exclusions include recent radiation or surgery, certain heart conditions, uncontrolled blood pressure or diabetes, active infections, and known HIV/HBV/HCV infection.

Inclusion Criteria

Voluntary written informed consent
Your white blood cell count, red blood cell count, and platelet count are within certain healthy ranges.
FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during specific time periods
See 9 more

Exclusion Criteria

I have moderate to severe numbness, tingling, or pain in my hands or feet.
Pregnant or lactating females
I have started or received treatment after a transplant.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a combination of Carfilzomib, Lenalidomide, and Dexamethasone or Lenalidomide alone after stem-cell transplant

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Carfilzomib
  • Dexamethasone
  • Lenalidomide
Trial Overview The study is testing the effectiveness of combining Carfilzomib with Lenalidomide and Dexamethasone against using only Lenalidomide after a stem-cell transplant in multiple myeloma patients. It's randomized: some get all drugs; others just one.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Combination RegimenExperimental Treatment3 Interventions
Group II: Lenalidomide (Control)Active Control1 Intervention

Carfilzomib is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Kyprolis for:
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Approved in European Union as Kyprolis for:
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Approved in Canada as Kyprolis for:
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Approved in Japan as Kyprolis for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Published Research Related to This Trial

In the ENDURANCE trial involving patients with newly diagnosed multiple myeloma, the combination of carfilzomib, lenalidomide, and dexamethasone (KRd) did not improve progression-free survival compared to the standard treatment of bortezomib, lenalidomide, and dexamethasone (VRd).
These findings suggest that KRd may not be a more effective treatment option than the current standard of care for patients with NDMM.
Carfilzomib Triplet Fails to Induce Superior PFS in Newly Diagnosed Multiple Myeloma.Skarzynski, J.[2021]
Carfilzomib, when used in combination with lenalidomide and dexamethasone, significantly prolongs progression-free survival (PFS) by 8.7 months in patients with relapsed multiple myeloma, based on results from the phase III ASPIRE study involving a multinational patient population.
The combination therapy has a manageable safety profile, with low incidences of severe adverse events, suggesting it is a viable treatment option for patients who have received prior therapies, although overall survival data is still pending.
Carfilzomib Triple Combination Therapy: A Review in Relapsed Multiple Myeloma.Hoy, SM.[2018]
In a study involving 792 patients with relapsed multiple myeloma, the combination of carfilzomib with lenalidomide and dexamethasone significantly improved progression-free survival, with a median of 26.3 months compared to 17.6 months for the control group.
The carfilzomib group also showed a higher overall response rate (87.1% vs. 66.7%) and better health-related quality of life, indicating a favorable risk-benefit profile despite similar rates of serious adverse events between the two groups.
Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma.Stewart, AK., Rajkumar, SV., Dimopoulos, MA., et al.[2022]

Citations

Carfilzomib Triplet Fails to Induce Superior PFS in Newly Diagnosed Multiple Myeloma. [2021]
Carfilzomib Triple Combination Therapy: A Review in Relapsed Multiple Myeloma. [2018]
Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. [2022]
Treatment With Carfilzomib-Lenalidomide-Dexamethasone With Lenalidomide Extension in Patients With Smoldering or Newly Diagnosed Multiple Myeloma. [2022]
Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study. [2020]
A phase IIb trial of vorinostat in combination with lenalidomide and dexamethasone in patients with multiple myeloma refractory to previous lenalidomide-containing regimens. [2018]
Safety profile of lenalidomide in patients with lower-risk myelodysplastic syndromes without del(5q): results of a phase 3 trial. [2019]
8.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Incidence and Management of Carfilzomib-induced Cardiovascular Toxicity; A Systematic Review and Meta-analysis. [2021]
Deep and ongoing response of castrate-resistant prostate cancer on very low-dose enzalutamide in an elderly chemotherapy-naïve patient: a case report. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Measuring cardiopulmonary complications of carfilzomib treatment and associated risk factors using the SEER-Medicare database. [2021]
Carfilzomib in addition to lenalidomide and dexamethasone in Asian patients with RRMM outside of a clinical trial. [2021]
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