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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01450215
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : March 25, 2016
Information provided by (Responsible Party):
Hareth Nahi, Karolinska University Hospital

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
Multiple Myeloma Drug: Revlimid Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2011
Actual Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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

Primary Outcome Measures :
  1. Time to progression [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01450215

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Karolinska Inst.
Stockholm, Sweden, S-141 86
Karolinska Institute
Stockholm, Sweden, S-141 86
Sponsors and Collaborators
Karolinska University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hareth Nahi, MD, PhD, clinical assoc.professor, Karolinska University Hospital Identifier: NCT01450215    
Other Study ID Numbers: PI-RV-MM-10-07/ RV-MM-PI 0627
2010-021857-38 ( EudraCT Number )
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Keywords provided by Hareth Nahi, Karolinska University Hospital:
Relapsed and refractory Multiple Myeloma
Additional relevant MeSH terms:
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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
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents