Clinical Trial: Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 Summary:

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 m
Sponsor: Mayo Clinic

Current Primary Outcome: 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: Progression-free survival rate at 1 year

Current Secondary Outcome:

  • 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:

  • 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


Information By: Mayo Clinic

Dates:
Date Received: October 12, 2008
Date Started: December 2008
Date Completion: May 2017
Last Updated: October 10, 2016
Last Verified: March 2016