Randomized Trial Comparing Lenalidomide With Low Dose Dexamethasone Versus Lenalidomide in Second Line Multiple Myeloma
Study Details
Study Description
Brief Summary
This is:
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A prospective, randomized, open, phase II, multi-centre, interventional study. Patients who are in at least PR and have received lenalidomide as 2nd line treatment for MM will be recruited.
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The patients will be randomized into two groups. Group R will receive lenalidomide 25 mg/day p.o. continuously for 21 days and group Rb will receive a similar dose of lenalidomide with the addition of 40 mg of dexamethasone p.o. on days 1, 8, 15 and 22 of every 28 day treatment cycle. Study includes a maximum of 24 cycles including two consolidating cycles per patients.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Revlimid
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Drug: Revlimid
Group R:25 mg lenalidomide 21 of 28 days will be given orally as maintenance .
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No Intervention: Revlimid and dexamethasone
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Outcome Measures
Primary Outcome Measures
- Time to progression [24 months]
Secondary Outcome Measures
- Number of Participants with Adverse Events [participants will be followed for the duration of hospital stay, an expected average of 2 years]
Number of Participants with Adverse Events
Eligibility Criteria
Criteria
Inclusion Criteria:
Inclusion Criteria - all subjects must:
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Be at least 18 years of age
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Subjects must have a documented diagnosis of MM and have either refractory or relapsed and refractory after first line treatment disease defined as:
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Primary refractory
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Refractory
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Relapsed and Refractory
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Subjects must have undergone prior treatment with one treatment line of anti-myeloma therapy. Induction therapy followed by ASCT and consolidation/maintenance will be considered as one line.Have a confirmed diagnosis of MM
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Have received lenalidomide after one prior treatment for MM and have reached at least a partial response (PR), according to IMWG criteria, including two consolidating cycles. Subjects have experienced a response at least PR after starting treatment with lenalidomide and cortisone cycles.
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Have personally signed and dated a legally effective written informed consent form prior to admission to the study.
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Must be willing and able to understand and comply with the study requirements.
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Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception.
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Male must agree to practice contraception
Exclusion Criteria:
- Any of the following laboratory abnormalities:
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Absolute neutrophil count (ANC) < 1,000/µL
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Platelet count < 75,000/ µL
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Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula
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Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
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Serum total bilirubin > 2.0 mg/dL
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ECOG performance status <4.
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Individuals who have had a stem-cell transplant as a 2nd line treatment for MM
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Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening.
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Individuals with significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical condition that might affect their experience of myeloma symptoms or their ability to describe them.
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Pregnant or lactating females.
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Any other clinically significant medical disease or condition that, in the Investigator´s opinion, may interfere with protocol adherence or a subject´s ability to give informed consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Karolinska Inst. | Stockholm | Sweden | S-141 86 | |
2 | Karolinska Institute | Stockholm | Sweden | S-141 86 |
Sponsors and Collaborators
- Karolinska University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI-RV-MM-10-07/ RV-MM-PI 0627
- 2010-021857-38