Lenalidomide + CC-486 + Radiation for Plasmacytoma

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining CC-486 (an experimental treatment), lenalidomide, and radiation therapy is safe and effective for treating plasmacytoma, a cancer affecting plasma cells in the bone marrow. It examines two groups: individuals with newly diagnosed or recurring solitary plasmacytoma and those with relapsed multiple myeloma that has spread. Suitable candidates for this trial have confirmed plasmacytoma or relapsed multiple myeloma, possibly with bone issues visible on scans, and have less than 10% of their bone marrow affected. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in this trial have been studied before, and each component appears safe.

Lenalidomide, tested with radiation therapy, is considered safe and improves results without major side effects. Most patients tolerate it well.

CC-486 is another treatment in this trial. Early research suggests it is generally well-tolerated by patients with similar conditions, though more detailed safety information is still being gathered.

Radiation therapy, particularly stereotactic body radiotherapy (SBRT), is also regarded as safe for treating plasmacytoma. It is practical and usually doesn't cause severe reactions.

Overall, these treatments have been used safely in the past. However, anyone considering participation should discuss possible side effects with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for plasmacytoma?

Researchers are excited about the combination of Lenalidomide, CC-486, and radiation therapy for treating plasmacytoma because it offers a unique approach that targets multiple aspects of the disease. Most current treatments focus mainly on chemotherapy and radiation. However, Lenalidomide is an immunomodulatory drug that enhances the immune system's ability to fight cancer cells, while CC-486, an oral form of azacitidine, works by modifying DNA to stop cancer cell growth. This innovative combination aims to provide a more comprehensive attack on the cancer, potentially improving outcomes for patients with both solitary bone plasmacytoma and relapsed multiple myeloma with plasmacytomas.

What evidence suggests that the combination of CC-486, lenalidomide, and radiation therapy could be an effective treatment for plasmacytoma?

Research has shown that radiation therapy, which participants in this trial will receive, effectively treats solitary plasmacytomas, providing strong local control and high response rates. Studies have found that adding lenalidomide, another treatment option in this trial, to radiation can improve results by slowing the disease's progression. This combination has benefited patients, helping them live longer without the disease worsening. Early research suggests that adding CC-486, also studied in this trial, to lenalidomide and radiation might enhance the treatment's effectiveness. These treatments work together to target and control the plasmacytoma, potentially leading to better outcomes for patients. ^{1 3 5 6 7}

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 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]

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]

Citations

1. ash.confex.com ash.confex.com/ash/2020/webprogram/Paper141131.html

Paper: A Pilot Study Evaluating Lenalidomide and CC-486 ... Solitary plasmacytoma of the bone (SPB) is a rare entity representing 5% of all plasma cell dyscrasias. SPB treated with radiation therapy (RT) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7539721/

Clinical presentation and outcomes of solitary ... Solitary plasmacytoma is a rare localised neoplasm of monoclonal plasma cells. The standard treatment involves radical radiotherapy.

3. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-017-0549-1

Diagnosis, treatment, and response assessment in solitary ... In some patients, a bone marrow aspiration can detect a low monoclonal plasma cell infiltration which indicates a high risk of early progression ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12286265/

Solitary Plasmacytomas: Current Status in 2025 - PMC Solitary plasmacytoma refers to a neoplastic, clonal proliferation of plasma cells forming a single mass. They are divided based on their origin ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0006497118714870

A Pilot Study Evaluating Lenalidomide and CC-486 in ... This is an open-label, single center, single-arm study of CC-486, lenalidomide plus RT, which will enroll a total of 20 patients in two cohorts.

6. mdpi.com mdpi.com/2038-8330/17/4/32

Solitary Plasmacytomas: Current Status in 2025 Solitary plasmacytomas (SPs) are plasma cell tumors characterized by the localized proliferation of malignant cells and carry the risk of progression to overt ...

7. haematologica.org haematologica.org/article/view/haematol.2022.282214

Chemotherapy in solitary bone plasmacytoma to prevent ... The aim of this study was to describe the characteristics and outcome of patients treated for SBP, to identify factors associated with ...