Status:
COMPLETED
Randomized Trial Comparing Lenalidomide With Low Dose Dexamethasone Versus Lenalidomide in Second Line Multiple Myeloma
Lead Sponsor:
Karolinska University Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is: * 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...
Eligibility Criteria
Inclusion
- Inclusion Criteria - all subjects must:
- Be at least 18 years of age
- Subjects must have a documented diagnosis of MM and have either refractory or relapsed and refractory after first line treatment disease defined as:
- Primary refractory
- Refractory
- Relapsed and Refractory
- 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
- 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.
- Have personally signed and dated a legally effective written informed consent form prior to admission to the study.
- Must be willing and able to understand and comply with the study requirements.
- Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception.
- Male must agree to practice contraception
Exclusion
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) \< 1,000/µL
- Platelet count \< 75,000/ µL
- Creatinine Clearance \< 45 mL/min according to Cockcroft-Gault formula
- Serum SGOT/AST or SGPT/ALT \> 3.0 x upper limit of normal (ULN)
- Serum total bilirubin \> 2.0 mg/dL
- ECOG performance status \<4.
- Individuals who have had a stem-cell transplant as a 2nd line treatment for MM
- Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening.
- 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.
- Pregnant or lactating females.
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01450215
Start Date
March 1 2011
Last Update
March 25 2016
Active Locations (2)
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1
Karolinska Inst.
Stockholm, Sweden, S-141 86
2
Karolinska Institute
Stockholm, Sweden, S-141 86