Lenalidomide + CC-486 + Radiation for Plasmacytoma

Recruiting at 9 trial locations

Overseen By Alexander Lesokhin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: CC-486, Lenalidomide

Must not be taking: Tacrolimus, Thalidomide

Disqualifiers: Pregnancy, Cardiac disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

21 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{6 9 11 12 13}

Who Is on the Research Team?

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.

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.

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?

Group I: Participants with Plasmacytoma Experimental Treatment 3 Interventions

Participants will have solitary bone plasmacytoma with minimal marrow involvement and participants with relapsed multiple myeloma with plasmacytomas

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: a novel anticancer drug with multiple modalities. Galustian, C., Dalgleish, A.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Solitary Plasmacytoma Treated by Lenalidomide-Dexamethasone in Combination with Radiation Therapy: Clinical Outcomes. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Immunomodulatory drugs Revlimid (lenalidomide) and CC-4047 induce apoptosis of both hematological and solid tumor cells through NK cell activation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Lenalidomide: an immunomodulatory drug. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Upfront bortezomib, lenalidomide, and dexamethasone compared to bortezomib, cyclophosphamide, and dexamethasone in multiple myeloma. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Lenalidomide: a novel anticancer drug with multiple modalities. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Successful rechallenge after ixabepilone-induced radiation recall dermatitis using an alternative dosing strategy. [2015]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Radiation recall dermatitis during treatment of endometrial cancer with pembrolizumab plus lenvatinib: A case report. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Cutaneous chemotherapy-induced radiation recall reaction. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

Unsuccessful rechallenge with pemetrexed after a previous radiation recall dermatitis. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Radiation recall dermatitis induced by COVID-19 vaccination in breast cancer patients treated with postoperative radiation therapy. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Extramedullary plasmacytomas in the context of multiple myeloma. [2011]

12. United States pubmed.ncbi.nlm.nih.gov

Lenalidomide enhances antigen-specific activity and decreases CD45RA expression of T cells from patients with multiple myeloma. [2021]

13. Czech Republic pubmed.ncbi.nlm.nih.gov

[Lenalidomid (Revlimid) in the treatment of multiple myeloma--first experience in the Czech Republic]. [2018]