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

Sponsor
Karolinska University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01450215
Collaborator
(none)
62
2
2
31

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Revlimid

Drug: Revlimid
Group R:25 mg lenalidomide 21 of 28 days will be given orally as maintenance .

No Intervention: Revlimid and dexamethasone

Outcome Measures

Primary Outcome Measures

  1. Time to progression [24 months]

Secondary Outcome Measures

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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

  2. 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.

  3. Have personally signed and dated a legally effective written informed consent form prior to admission to the study.

  4. Must be willing and able to understand and comply with the study requirements.

  5. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception.

  6. 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

  1. ECOG performance status <4.

  2. Individuals who have had a stem-cell transplant as a 2nd line treatment for MM

  3. Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening.

  4. 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.

  5. Pregnant or lactating females.

  6. 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
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.
Responsible Party:
Hareth Nahi, MD, PhD, clinical assoc.professor, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01450215
Other Study ID Numbers:
  • PI-RV-MM-10-07/ RV-MM-PI 0627
  • 2010-021857-38
First Posted:
Oct 12, 2011
Last Update Posted:
Mar 25, 2016
Last Verified:
Mar 1, 2016
Keywords provided by Hareth Nahi, MD, PhD, clinical assoc.professor, Karolinska University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2016