What is the mechanism of action of this treatment?

CC-486, a hypomethylating agent, works by inhibiting DNA methylation, which can reactivate tumor suppressor genes and induce cancer cell death. Lenalidomide, an immunomodulatory drug, enhances the immune system's ability to attack cancer cells, inhibits angiogenesis (formation of new blood vessels that feed tumors), and directly induces cancer cell apoptosis. Radiation therapy uses high-energy radiation to damage the DNA of cancer cells, leading to cell death and tumor shrinkage. These treatments are crucial for Plasmacytoma patients as they target the cancer cells through different mechanisms, potentially leading to more effective and comprehensive treatment outcomes.

What side effects are associated with this type of intervention?

The most common treatments for plasmacytoma include hypomethylating agents like CC-486, immunomodulatory drugs like lenalidomide, and radiation therapy. CC-486 can cause side effects such as nausea, vomiting, diarrhea, fatigue, and cytopenias (low blood cell counts). Lenalidomide is associated with side effects including fatigue, diarrhea, constipation, rash, and an increased risk of blood clots. Radiation therapy can lead to skin irritation, fatigue, and localized pain or discomfort in the treated area. Patients may experience varying degrees of these side effects, and it is important to discuss them with a healthcare provider to manage and mitigate their impact.

What prior FDA approvals exist?

The FDA has approved several treatments for plasma cell neoplasms, including multiple myeloma, which are relevant to plasmacytoma. Lenalidomide, an immunomodulatory drug, has been approved for multiple myeloma and is often used in combination with other therapies. Hypomethylating agents like azacitidine (CC-486) are also used in hematologic malignancies, though specific approvals for plasmacytoma are less clear. Radiation therapy remains a standard treatment for localized plasmacytoma, providing high-energy radiation to target and destroy cancer cells.

What other types of research exist?

Promising novel alternatives for plasmacytoma treatment in 2024 may include: 1) CAR-T cell therapy, which has shown success in other hematologic malignancies by targeting specific antigens on cancer cells; 2) Bispecific T-cell engagers (BiTEs) like blinatumomab, which direct the body's immune system to attack cancer cells; 3) Next-generation proteasome inhibitors such as carfilzomib, which have been effective in multiple myeloma; 4) Monoclonal antibodies like daratumumab, which target specific proteins on cancer cells; and 5) Novel small molecule inhibitors targeting specific mutations or pathways involved in plasmacytoma pathogenesis.

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Anti-neoplastic agent

Lenalidomide + CC-486 + Radiation for Plasmacytoma

Phase 2

Waitlist Available

Led By Urvi Shah, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to swallow oral medication

Creatinine clearance >/=30ml/min by Cockroft-Gault method

Must not have

History of inflammatory bowel disease, celiac disease, prior gastrectomy, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug

Significant active cardiac disease within the previous 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of cycle 6 (each cycle is 28 days)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include digestive issues due to oral medication intake, allergic reactions to the drugs used (azacitidine, mannitol, thalidomide), changes in blood counts leading to increased infection risk or bleeding problems, fatigue from treatment regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take pills by mouth.

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My kidneys work well enough to clear waste.

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I am 18 years old or older.

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I can take aspirin daily.

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I am fully active or can carry out light work.

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I have a new or returning single bone marrow cancer with little bone marrow involvement and low M protein levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of serious gut issues that could affect how I process medication.

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I have not had serious heart problems in the last 6 months.

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I am not on any cancer treatments except for CC-486 or lenalidomide.

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I do not have any uncontrolled infections.

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I am allergic to azacitidine, mannitol, thalidomide, or lenalidomide.

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I do not have an active HIV, HBV, or HCV infection.

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I developed a peeling rash from thalidomide or similar medications.

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I am currently taking tacrolimus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of cycle 6 (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of cycle 6 (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of cycle 6 (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure Complete Response

Side effects data

From 2023 Phase 2 trial • 240 Patients • NCT02250326

57%

Nausea

53%

Vomiting

42%

Diarrhoea

41%

Constipation

34%

Decreased appetite

33%

Asthenia

32%

Alopecia

30%

Fatigue

24%

Peripheral sensory neuropathy

20%

Cough

20%

Dyspnoea

19%

Neutropenia

15%

Anaemia

15%

Oedema peripheral

14%

Arthralgia

13%

Pyrexia

13%

Paraesthesia

11%

Headache

11%

Weight decreased

11%

Myalgia

11%

Insomnia

10%

Stomatitis

10%

Dizziness

Pulmonary embolism

Abdominal pain

Musculoskeletal pain

Pleural effusion

Dry skin

Pain in extremity

Neutrophil count decreased

Dyspepsia

Leukopenia

Muscle spasms

Pneumonia

Nasopharyngitis

Oral candidiasis

Anxiety

General physical health deterioration

Haemorrhoids

Back pain

Vision blurred

Haemoptysis

Vertigo

Muscular weakness

Upper respiratory tract infection

Productive cough

Abdominal pain upper

Non-cardiac chest pain

Epistaxis

Musculoskeletal chest pain

Hypophosphataemia

Urinary tract infection

Rhinorrhoea

Pruritus

Pruritus generalised

Hypomagnesaemia

Alanine aminotransferase increased

Performance status decreased

Respiratory tract infection

Bronchitis

Hypotension

Cancer pain

Hemiparesis

Pneumonitis

Lower respiratory tract infection

Hyponatraemia

Paraparesis

Abdominal wall abscess

Blood glucose increased

Generalised tonic-clonic seizure

Intestinal obstruction

Confusional state

Acute kidney injury

Haematuria

Acute respiratory distress syndrome

Interstitial lung disease

Flushing

Circulatory collapse

Influenza

Febrile neutropenia

Metastases to meninges

Flatulence

Urinary tract obstruction

Respiratory distress

Pneumonia pneumococcal

Sudden death

100%

80%

60%

40%

20%

Study treatment Arm

Nab-Paclitaxel + CC-486

Nab-Paclitaxel + Durvalumab

Nab-Paclitaxel

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

CC-486

2015

Completed Phase 2

~670

Lenalidomide

2005

Completed Phase 3

~2240

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

CC-486, a hypomethylating agent, works by inhibiting DNA methylation, which can reactivate tumor suppressor genes and induce cancer cell death. Lenalidomide, an immunomodulatory drug, enhances the immune system's ability to attack cancer cells, inhibits angiogenesis (formation of new blood vessels that feed tumors), and directly induces cancer cell apoptosis. Radiation therapy uses high-energy radiation to damage the DNA of cancer cells, leading to cell death and tumor shrinkage. These treatments are crucial for Plasmacytoma patients as they target the cancer cells through different mechanisms, potentially leading to more effective and comprehensive treatment outcomes.

Integration of Novel Agents into the Care of Patients with Multiple Myeloma.An update of the management of multiple myeloma: the changing landscape.