21 Participants Needed

Lenalidomide + CC-486 + Radiation for Plasmacytoma

Recruiting at 9 trial locations
US
AL
Overseen ByAlexander Lesokhin, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: CC-486, Lenalidomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 trial is testing a combination of two drugs and radiation therapy to treat patients with plasmacytoma. The drugs help stop cancer growth and boost the immune system, while radiation kills the cancer cells.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot participate if you are on tacrolimus therapy or concurrent systemic chemotherapy with drugs other than CC-486 and lenalidomide. It's best to discuss your current medications with the trial team to see if they are compatible with the study.

Is the combination of Lenalidomide, CC-486, and Radiation generally safe for humans?

The research articles discuss a condition called radiation recall dermatitis, which is an inflammatory skin reaction that can occur after radiation therapy when certain drugs are administered. This condition is rare and can be managed with treatments like antihistamines and topical steroids, but it highlights a potential safety concern when combining radiation with certain medications.12345

What makes the treatment of Lenalidomide + CC-486 + Radiation unique for plasmacytoma?

This treatment combines lenalidomide, which boosts the immune system's response to cancer, with CC-486 and radiation therapy to target plasmacytoma, a condition with limited standard treatment options. The combination aims to enhance the effectiveness of radiation therapy, which is the most effective for local control of plasmacytoma, by using lenalidomide's ability to improve immune function.678910

What data supports the effectiveness of the drug Lenalidomide in treating plasmacytoma?

Research shows that Lenalidomide, when used with radiation therapy, has been effective in treating solitary plasmacytoma, a type of cancer. Additionally, Lenalidomide has demonstrated anti-tumor activity in various cancers, including multiple myeloma, by enhancing the body's immune response to fight cancer cells.69111213

Who Is on the Research Team?

Urvi A. Shah, MD - MSK Myeloma Specialist

Urvi Shah, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with plasmacytoma or multiple myeloma who can take daily aspirin, swallow pills, and have a life expectancy over 3 months. Women must avoid pregnancy and men must not donate sperm during the study. Participants need functioning liver and kidneys, an ECOG status of 0-1, and meet specific blood criteria.

Inclusion Criteria

Your bilirubin levels in the blood are not too high.
I can take pills by mouth.
My kidneys work well enough to clear waste.
See 13 more

Exclusion Criteria

I have a history of serious gut issues that could affect how I process medication.
I have not had serious heart problems in the last 6 months.
You have unusual blood clotting levels without a known cause.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CC-486 with lenalidomide and radiation therapy for plasmacytoma

24 weeks
6 cycles of 28 days each

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CC-486
  • Lenalidomide
  • Radiation Therapy
Trial Overview The study tests if CC-486 combined with lenalidomide and radiation therapy is safe/effective against plasmacytoma. It includes two groups: one with newly diagnosed or recurrent solitary plasmacytoma/lytic lesion; another with relapsed multiple myeloma suitable for radiation.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Participants with PlasmacytomaExperimental Treatment3 Interventions
Participants will have solitary bone plasmacytoma with minimal marrow involvement and participants with relapsed multiple myeloma with plasmacytomas

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

Lenalidomide, a derivative of thalidomide, has improved potency and a better side-effect profile, particularly with reduced neurologic toxicity compared to its predecessor.
While lenalidomide shows promise in treating conditions like myelodysplastic syndrome and multiple myeloma, there are still concerns about pro-thrombotic effects, especially when used with dexamethasone.
Lenalidomide: an immunomodulatory drug.Crane, E., List, A.[2018]
Lenalidomide has become a crucial treatment option for multiple myeloma and del-5q myelodysplastic syndromes, and it has been tested for various other cancers, showcasing its broad therapeutic potential.
The drug received FDA approval for use in combination with dexamethasone for previously treated multiple myeloma, highlighting its efficacy and safety in this specific patient population.
Lenalidomide: a novel anticancer drug with multiple modalities.Galustian, C., Dalgleish, A.[2019]

Citations

Solitary Plasmacytoma Treated by Lenalidomide-Dexamethasone in Combination with Radiation Therapy: Clinical Outcomes. [2020]
Immunomodulatory drugs Revlimid (lenalidomide) and CC-4047 induce apoptosis of both hematological and solid tumor cells through NK cell activation. [2022]
Lenalidomide: an immunomodulatory drug. [2018]
Upfront bortezomib, lenalidomide, and dexamethasone compared to bortezomib, cyclophosphamide, and dexamethasone in multiple myeloma. [2020]
Lenalidomide: a novel anticancer drug with multiple modalities. [2019]
Successful rechallenge after ixabepilone-induced radiation recall dermatitis using an alternative dosing strategy. [2015]
Radiation recall dermatitis during treatment of endometrial cancer with pembrolizumab plus lenvatinib: A case report. [2023]
Cutaneous chemotherapy-induced radiation recall reaction. [2021]
Unsuccessful rechallenge with pemetrexed after a previous radiation recall dermatitis. [2022]
Radiation recall dermatitis induced by COVID-19 vaccination in breast cancer patients treated with postoperative radiation therapy. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Extramedullary plasmacytomas in the context of multiple myeloma. [2011]
12.United Statespubmed.ncbi.nlm.nih.gov
Lenalidomide enhances antigen-specific activity and decreases CD45RA expression of T cells from patients with multiple myeloma. [2021]
13.Czech Republicpubmed.ncbi.nlm.nih.gov
[Lenalidomid (Revlimid) in the treatment of multiple myeloma--first experience in the Czech Republic]. [2018]
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