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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 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
9%
Pulmonary embolism
9%
Abdominal pain
9%
Musculoskeletal pain
8%
Pleural effusion
8%
Dry skin
8%
Pain in extremity
6%
Dyspepsia
6%
Neutrophil count decreased
6%
Leukopenia
6%
Muscle spasms
6%
Pneumonia
6%
Nasopharyngitis
6%
Oral candidiasis
6%
Anxiety
5%
General physical health deterioration
5%
Haemorrhoids
5%
Back pain
5%
Vision blurred
5%
Haemoptysis
5%
Vertigo
5%
Muscular weakness
4%
Upper respiratory tract infection
4%
Productive cough
4%
Abdominal pain upper
4%
Non-cardiac chest pain
4%
Epistaxis
4%
Musculoskeletal chest pain
4%
Hypophosphataemia
3%
Pruritus generalised
3%
Pruritus
3%
Urinary tract infection
3%
Rhinorrhoea
3%
Hypomagnesaemia
3%
Alanine aminotransferase increased
3%
Performance status decreased
3%
Respiratory tract infection
3%
Bronchitis
3%
Hypotension
3%
Cancer pain
1%
Hyponatraemia
1%
Pneumonitis
1%
Hemiparesis
1%
Lower respiratory tract infection
1%
Paraparesis
1%
Abdominal wall abscess
1%
Blood glucose increased
1%
Generalised tonic-clonic seizure
1%
Intestinal obstruction
1%
Confusional state
1%
Acute kidney injury
1%
Haematuria
1%
Acute respiratory distress syndrome
1%
Interstitial lung disease
1%
Flushing
1%
Circulatory collapse
1%
Influenza
1%
Febrile neutropenia
1%
Metastases to meninges
1%
Flatulence
1%
Urinary tract obstruction
1%
Respiratory distress
1%
Pneumonia pneumococcal
1%
Sudden death
100%
80%
60%
40%
20%
0%
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

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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,964 Previous Clinical Trials
596,915 Total Patients Enrolled
17 Trials studying Plasmacytoma
414 Patients Enrolled for Plasmacytoma
Urvi Shah, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
273 Total Patients Enrolled

Media Library

Plasmacytoma Research Study Groups: Participants with Plasmacytoma
Plasmacytoma Clinical Trial 2023: CC-486 Highlights & Side Effects. Trial Name: NCT04174196 — Phase 2
~0 spots leftby Nov 2024
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