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Trial record 63 of 374 for:    LENALIDOMIDE AND Dexamethasone

Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed 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.
 
ClinicalTrials.gov Identifier: NCT00772915
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : August 8, 2012
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE October 12, 2008
First Posted Date  ICMJE October 15, 2008
Results First Submitted Date  ICMJE June 26, 2012
Results First Posted Date  ICMJE August 8, 2012
Last Update Posted Date July 24, 2018
Actual Study Start Date  ICMJE December 3, 2008
Actual Primary Completion Date March 22, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
Progression-free Survival Rate at 12 Months [ Time Frame: 12 months from registration ]
PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of registration.
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2008)
Progression-free survival rate at 1 year
Change History Complete list of historical versions of study NCT00772915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2012)
  • Overall Response Rate [ Time Frame: Up to 18 cycles from registration ]
    Response that was confirmed on 2 consecutive evaluations during treatment
    • Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)
    • Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM
    • Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels
  • Overall Survival (OS) [ Time Frame: Time from registration to death (up to 3 years) ]
    OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 3 years from randomization. The median OS with 95% CI was estimated using the Kaplan Meier method
  • Progression-free Survival (PFS) [ Time Frame: Time from registration to progression or death (up to 3 years) ]
    PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method. Progression was defined as any one or more of the following:An increase of 25% from lowest confirmed response in:
    • Serum M-component (absolute increase >= 0.5g/dl)
    • Urine M-component (absolute increase >= 200mg/24hour
    • Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl
    • Bone marrow plasma cell percentage (absolute increase of >=10%)
  • Adverse Events [ Time Frame: Duration on treatment (up to 18 cycles from registration) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2008)
  • Overall Response Rate
  • Overall survival
  • Progression-free survival
  • Parameter of immune activation in lenalidomide alone
  • Global parameters of immune function and levels of antibodies
  • Antiangiogenesis activity
  • Cell proliferation levels
  • Adverse Events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Official Title  ICMJE A Phase II Trial of Revlimid® and "On Demand" Dexamethasone Dosing in Patients With Newly Diagnosed Symptomatic Multiple Myeloma
Brief Summary

RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well lenalidomide works with or without dexamethasone in treating patients with newly diagnosed multiple myeloma.

Detailed Description

OBJECTIVES:

Primary

  • To assess the progression-free survival at 1 year in patients with newly diagnosed symptomatic multiple myeloma treated with lenalidomide alone or in combination with dexamethasone added for disease progression or lack or partial response.

Secondary

  • To assess the response rate of this regimen in these patients.
  • To assess the toxicity of this regimen in these patients.

Tertiary

  • To examine the effect of lenalidomide alone on tumor specific immunity and global parameters of immune function.
  • To examine the effect of dexamethasone addition in patients requiring steroids.
  • To correlate changes in parameters of immune response and measures of disease response.
  • To examine the antiangiogenic activity of lenalidomide alone and in combination with dexamethasone.
  • To examine the effect of lenalidomide alone on tumor cell survival and proliferation.

OUTLINE: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of second disease progression or unacceptable toxicity. Beginning in course 4, patients experiencing stable or progressive disease also receive concurrent oral dexamethasone once daily on days 1, 8, 15, and 22 and for all subsequent courses.

Blood and bone marrow samples are collected periodically for pharmacological and correlative studies. Samples are analyzed for parameters of immune activation, cell proliferation and apoptosis, and circulating tumor cells and endothelial cells via flow cytometry; global impact of therapy on immune cell subsets via immunophenotype analysis; and angiogenesis via CD34 staining.

After completion of study therapy, patients are followed periodically for up to 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma and Plasma Cell Neoplasm
Intervention  ICMJE
  • Drug: dexamethasone

    Dose: -40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.

    If after 3 cycles, a partial response is not achieved on lenalidomide alone, dexamethasone 10 mg weekly will be added, and the weekly dexamethasone dose will be increased by 10 mg each cycle to a maximum of 40 mg weekly, as long as a partial response is not achieved. If a partial response is achieved at a dose of dexamethasone less than 40 mg weekly, patients will continue on that dose. If progression at any time, increase dexamethasone to 40 mg weekly. Patient will go off study only when progression is documented while receiving 40 mg/week of dexamethasone or the maximum tolerated dose of dexamethasone (if prior dose reductions have been implemented for toxicity). Increases in dexamethasone dose are to be made only at the initiation of a cycle.

    If progression at any time while on lenalidomide alone (first 3 cycles), add dexamethasone 40 mg weekly.

  • Drug: lenalidomide

    25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.

    Lenalidomide alone will be administered for the first 3 cycles, then in combination with dexamethasone as needed (described).

Study Arms  ICMJE Experimental: Lenalidomide with On-Demand Dexamethasone

Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.

Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.

Interventions:
  • Drug: dexamethasone
  • Drug: lenalidomide
Publications * Not Provided

*   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: October 12, 2008)
39
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 27, 2018
Actual Primary Completion Date March 22, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Newly diagnosed multiple myeloma, meeting the following criteria:

    • Symptomatic disease
    • Previously untreated disease
  • Measurable or evaluable disease, defined by ≥ 1 of the following:

    • Serum monoclonal protein ≥ 1.0 g/dL
    • Monoclonal protein > 200 mg by 24-hour urine electrophoresis
    • Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa:lambda free light chain ratio
    • Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
    • Measurable soft tissue plasmacytoma, not previously radiated
  • No monoclonal gammopathy of unknown significance or asymptomatic myeloma

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 (PS 3 allowed if secondary to pain)
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 75,000/μL
  • Creatinine ≤ 2.0 mg/dL
  • Total bilirubin ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective forms of contraception 28 days prior to, during and 28 days after study treatment
  • Registered into the RevAssist® program and willing to comply with program requirements
  • Able to take prophylactic aspirin (325 mg/day) or warfarin or low molecular weight heparin
  • Willing to provide mandatory blood and bone marrow samples
  • Willing to return for follow up
  • No uncontrolled infection
  • No NYHA class III or IV heart failure
  • No active deep vein thrombosis that has not been therapeutically anticoagulated
  • No known hypersensitivity to thalidomide
  • No known HIV positivity
  • No known hepatitis type A, B, or C infection
  • No other prior active malignancy within the past 2 years, except currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
  • No development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs

PRIOR CONCURRENT THERAPY:

  • At least 3 weeks since prior radiotherapy for solitary plasmacytoma
  • More than 28 days since other prior experimental drug or therapy
  • Prior clarithromycin, DHEA, anakinra, pamidronate, or zoledronic acid allowed
  • No prior lenalidomide
  • No prior cytotoxic chemotherapy
  • No prior corticosteroids (≥ 160 mg of dexamethasone or equivalent) for this disease

    • Prior corticosteroid for nonmalignant disease allowed
    • Concurrent corticosteroids allowed (≤ 20 mg/day of prednisone or equivalent)
  • Concurrent palliative radiotherapy for bone pain or fracture allowed
  • No other concurrent anticancer agents or treatments
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00772915
Other Study ID Numbers  ICMJE CDR0000616057
P30CA015083 ( U.S. NIH Grant/Contract )
MC0884 ( Other Identifier: Mayo Clinic Cancer Center )
08-002093 ( Other Identifier: Mayo Clinic IRB )
NCI-2009-01201 ( Registry Identifier: NCI CTRP )
RV-MM-PI-367 ( Other Identifier: Celgene Protocol )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Shaji K. Kumar, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date June 2018

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