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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hareth Nahi, Karolinska University Hospital
ClinicalTrials.gov Identifier:
First received: September 7, 2011
Last updated: September 24, 2014
Last verified: September 2014

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 Intervention Phase
Multiple Myeloma
Drug: Revlimid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 years ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events

Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Revlimid Drug: Revlimid
Group R:25 mg lenalidomide 21 of 28 days will be given orally as maintenance .
No Intervention: Revlimid and dexamethasone


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01450215

Karolinska Inst.
Stockholm, Sweden, S-141 86
Karolinska Institute
Stockholm, Sweden, S-141 86
Sponsors and Collaborators
Karolinska University Hospital
  More Information

No publications provided

Responsible Party: Hareth Nahi, MD, PhD, clinical assoc.professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01450215     History of Changes
Other Study ID Numbers: PI-RV-MM-10-07/ RV-MM-PI 0627  2010-021857-38 
Study First Received: September 7, 2011
Last Updated: September 24, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
Relapsed and refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 10, 2016