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Revlimid for Multiple Myeloma
Phase 3
Waitlist Available
Led By Bart Barlogie, MD, PhD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial
Summary
The purpose of this study is to determine in a phase II trial, whether further maintenance therapy with Revlimid can extend the duration of progression-free survival and the duration of complete or near complete response compared to no further therapy beyond the TT3 protocol-prescribed 3 years of maintenance with 1 year of VTD plus 2 years with TD, 3 years with VTD (2003-33) or VRD (2006-66).
Eligible Conditions
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS)
Side effects data
From 2014 Phase 3 trial • 42 Patients • NCT0162167268%
Grade 1 Hypoalbuminemia
52%
Grade 1 Thrombocytopenia
36%
Grade 2 Leukopenia
32%
Grade 1 Anemia
28%
Grade 1 Creatinine increase
24%
Grade 1 SGPT (ALT) increase
20%
Grade 1 Hypokalemia
20%
Grade 1 Hyperglycemia
20%
Grade 2 Sensory/Neuropathy
20%
Grade 1 SGOT (AST) increase
16%
Grade 1 Bilirubin increase
12%
Grade 1 Diarrhea
12%
Grade 4 Leukopenia
12%
Grade 1 Alkaline phosphatase increase
12%
Grade 2 Hypocalcemia
12%
Grade 1 Cough
8%
Grade 2 Creatinine increase
8%
Grade 3 Anemia
8%
Grade 3 Gait/ walking
8%
Grade 2 Hypophosphatemia
8%
Grade 2 Diarrhea
8%
Grade 2 Hypothyroidism
8%
Grade 1 Hyponatremia
8%
Grade 1 Joint
8%
Grade 1 Sensory/Neuropathy
8%
Grade 2 Upper Back
8%
Grade 4 Thrombocyopenia
8%
Grade 2 Hypoalbuminemia
8%
Grade 1 Rhinitis
8%
Grade 1 Fatigue
4%
Grade 3 CNS Ischemia
4%
Grade 3 Dysphagia
4%
Grade 3 Skin Rash/desquamation
4%
Grade 3 Hypokalemia
4%
Grade 3 Hypophosphatemia
4%
Grade 3 Sensory/Neuropathy
4%
Grade 3 Extremity/limb
4%
Grade 4 Hypocalcemia
4%
Grade 3 Mood alteration
4%
Grade 4 Neutropenia/granulocytopenia
4%
Grade 3 Allergic reaction/Hypersensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Revlimid
Observation
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RevlimidExperimental Treatment1 Intervention
Revlimid dosing will be in the morning at the same time each day
Group II: No further treatmentActive Control1 Intervention
No treatment control.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Find a Location
Who is running the clinical trial?
University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,577 Total Patients Enrolled
54 Trials studying Multiple Myeloma
11,938 Patients Enrolled for Multiple Myeloma
Bart Barlogie, MD, PhDPrincipal InvestigatorUAMS Myeloma Institute for Research & Therapy
8 Previous Clinical Trials
7,032 Total Patients Enrolled
7 Trials studying Multiple Myeloma
7,020 Patients Enrolled for Multiple Myeloma
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