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Randomized Trial Comparing Lenalidomide With Low Dose Dexamethasone Versus Lenalidomide in Second Line Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01450215
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
Hareth Nahi, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE September 7, 2011
First Posted Date  ICMJE October 12, 2011
Last Update Posted Date March 25, 2016
Study Start Date  ICMJE March 2011
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2011)
Time to progression [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01450215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2011)
Number of Participants with Adverse Events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 years ]
Number of Participants with Adverse Events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial Comparing Lenalidomide With Low Dose Dexamethasone Versus Lenalidomide in Second Line Multiple Myeloma
Official Title  ICMJE Not Provided
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.
  • 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Drug: Revlimid
Group R:25 mg lenalidomide 21 of 28 days will be given orally as maintenance .
Study Arms  ICMJE
  • Experimental: Revlimid
    Intervention: Drug: Revlimid
  • No Intervention: Revlimid and dexamethasone
Publications * Lund J, Gruber A, Lauri B, Duru AD, Blimark C, Swedin A, Hansson M, Forsberg K, Ahlberg L, Carlsson C, Waage A, Gimsing P, Vangsted AJ, Frølund U, Holmberg E, Gahrton G, Alici E, Hardling M, Mellqvist UH, Nahi H. Lenalidomide versus lenalidomide + dexamethasone prolonged treatment after second-line lenalidomide + dexamethasone induction in multiple myeloma. Cancer Med. 2018 Jun;7(6):2256-2268. doi: 10.1002/cam4.1422. Epub 2018 Apr 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2016)
62
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2011)
60
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion Criteria - all subjects must:

  1. Be at least 18 years of age
  2. 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
  3. 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
  4. 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.
  5. Have personally signed and dated a legally effective written informed consent form prior to admission to the study.
  6. Must be willing and able to understand and comply with the study requirements.
  7. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception.
  8. Male must agree to practice contraception

Exclusion Criteria:

  1. 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
  2. ECOG performance status <4.
  3. Individuals who have had a stem-cell transplant as a 2nd line treatment for MM
  4. Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening.
  5. 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.
  6. Pregnant or lactating females.
  7. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01450215
Other Study ID Numbers  ICMJE PI-RV-MM-10-07/ RV-MM-PI 0627
2010-021857-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hareth Nahi, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Karolinska University Hospital
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP