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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of cycle 6 (each cycle is 28 days)
Awards & highlights

Study Summary

This trial is testing if a new drug combo is safe and effective against plasmacytoma.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Muscle spasms
6%
Neutrophil count decreased
6%
Leukopenia
6%
Dyspepsia
6%
Pneumonia
6%
Nasopharyngitis
6%
Oral candidiasis
6%
Anxiety
5%
Haemorrhoids
5%
Back pain
5%
General physical health deterioration
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%
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%
Lower respiratory tract infection
1%
Abdominal wall abscess
1%
Hemiparesis
1%
Generalised tonic-clonic seizure
1%
Blood glucose increased
1%
Hyponatraemia
1%
Paraparesis
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 Combination Arm
Nab-Paclitaxel + Durvalumab Combination Arm
Nab-Paclitaxel Monotherapy Arm

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
~630
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,601 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic applications are most often associated with CC-486?

"CC-486 offers a potential remedy for multiple myeloma, relapsed or refractory lymphomas, and chronic lymphocytic leukemias."

Answered by AI

How many participants are there in this clinical trial?

"Affirmative. According to the data available on clinicaltrials.gov, this medical experiment is presently enrolling participants from 7 centres and requires 20 patients in total. This study was posted on November 19th 2019 with its latest edit being made on May 6th 2022."

Answered by AI

Is there an open call for participants in this medical study?

"According to clinicaltrials.gov, the recruitment process for this medical trial is ongoing and has been active since November 19th 2019 with a recent update on May 6th 2022."

Answered by AI

What potential risks do patients face when using CC-486?

"CC-486 is ranked a 2 on our safety scale as it has not yet been approved by regulatory authorities and only limited data exists to support its efficacy."

Answered by AI

How many venues is this experiment being conducted in?

"Presently, this medical study is occurring in 7 locations across the country, some of which are New york, Montvale and Uniondale. When selecting a site to participate from it's important to choose one that requires minimal travel time for you."

Answered by AI

What precedent exists for research involving CC-486?

"CC-486 was initially studied in 2004 at the Midwest Center for Hematology Oncology. Since then, it has been used as a part of 457 concluded clinical trials and 268 current ones taking place predominantly in New york City."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma
2019. "A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04174196.
~2 spots leftby Nov 2024
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