Study Summary
This trial is testing if a new drug combo is safe and effective against plasmacytoma.
Eligible Conditions
- Plasmacytoma of Bone
- Multiple Myeloma
- Plasmacytoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: At the end of Cycle 6 (each cycle is 28 days)
Day 28
Measure Complete Response
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
CC-486 200 mg
100%Nausea
50%Diarrhoea
50%Neutropenia
50%Fatigue
50%Vomiting
33%Arthralgia
33%Febrile neutropenia
33%Decreased appetite
33%Stomatitis
33%Neutrophil count decreased
17%Diverticulitis
17%Ear infection
17%Oral candidiasis
17%Cough
17%Blood creatinine increased
17%Abdominal pain upper
17%Pneumonia
17%Respiratory tract infection
17%Hyperammonaemia
17%Back pain
17%Pleural effusion
17%Rhinorrhoea
17%Pruritus generalised
17%Pyrexia
17%Thrombocytopenia
17%Sinus tachycardia
17%Diabetes insipidus
17%Abdominal pain
17%Constipation
17%Inguinal hernia
17%Hypokalaemia
17%Hypomagnesaemia
17%Headache
17%Syncope
17%Bacteraemia
17%Hypothermia
17%Nosocomial infection
17%Oedema peripheral
17%Neck pain
17%Humerus fracture
17%Brain oedema
17%Skin infection
17%Hyperglycaemia
17%Cerebrovascular accident
17%Dizziness
17%Hypocalcaemia
17%Hypoglycaemia
17%Hypoalbuminaemia
17%Toothache
17%Metabolic acidosis
17%Pain of skin
17%Musculoskeletal chest pain
17%Neuropathy peripheral
17%Productive cough
17%Insomnia
17%Anxiety
17%Decubitus ulcer
17%Rash maculo-papular
17%Hypotension
17%Anaemia
17%Eye oedema
17%Abdominal distension
17%Septic shock
17%Deafness unilateral
17%Dental caries
17%Dyspepsia
17%Blood alkaline phosphatase increased
17%Aspartate aminotransferase increased
17%Upper respiratory tract infection
17%Alanine aminotransferase increased
17%Nasal congestion
17%Menstrual disorder
Trial Design
1 Treatment Group
Participants with Plasmacytoma
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: CC-486 · No Placebo Group · Phase 2
Participants with PlasmacytomaExperimental Group · 3 Interventions: CC-486, Radiation Therapy, Lenalidomide · Intervention Types: Drug, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-486
2015
Completed Phase 2
~330
Radiation Therapy
2005
Completed Phase 3
~7010
Lenalidomide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at the end of cycle 6 (each cycle is 28 days)
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,834 Previous Clinical Trials
588,346 Total Patients Enrolled
Urvi Shah, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
170 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have relapsed multiple myeloma with plasmacytomas/lytic lesion appropriate for RT on imaging.
You are a recipient of a transplant.\n
Surgical resection of plasmacytoma or stabilization surgery is permitted if necessary based on physician judgement.
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Conditions
Cancer Related
Treatments