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

This study has been completed.
Information provided by (Responsible Party):
Hareth Nahi, Karolinska University Hospital Identifier:
First received: September 7, 2011
Last updated: March 24, 2016
Last verified: March 2016

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
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 ]

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 ]
    Number of Participants with Adverse Events

Enrollment: 62
Study Start Date: March 2011
Primary Completion Date: January 2016 (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   (Adult, Senior)
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
  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 identifier: NCT01450215

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

Responsible Party: Hareth Nahi, MD, PhD, clinical assoc.professor, Karolinska University Hospital Identifier: NCT01450215     History of Changes
Other Study ID Numbers: PI-RV-MM-10-07/ RV-MM-PI 0627
2010-021857-38 ( EudraCT Number )
Study First Received: September 7, 2011
Last Updated: March 24, 2016

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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents processed this record on April 21, 2017