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Trial record 20 of 896 for:    LENALIDOMIDE

Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma (07-REV)

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ClinicalTrials.gov Identifier: NCT00847639
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : April 4, 2014
Sponsor:
Collaborators:
National Marrow Donor Program
Celgene Corporation
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

Tracking Information
First Submitted Date  ICMJE February 17, 2009
First Posted Date  ICMJE February 19, 2009
Last Update Posted Date April 4, 2014
Study Start Date  ICMJE February 2009
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
To determine tolerability and safety profile of a maximum of 12 cycles or 12 months from first dose (which ever comes first) of lenalidomide maintenance therapy post allogeneic hematopoietic cell transplantation for high risk multiple myeloma. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00847639 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
  • To estimate the incidences of ≥ grade 3 adverse events, graft failure, infections, treatment-related mortality (TRM) and incidence and severity of acute and chronic GVHD after initiation of lenalidomide. [ Time Frame: 13 months ]
  • To measure the overall response and best response rates to lenalidomide maintenance therapy following allogeneic HCT. [ Time Frame: 13 Months ]
  • To determine time to disease progression and overall survival after lenalidomide. [ Time Frame: 13 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma
Official Title  ICMJE Evaluation of Lenalidomide as Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for High-risk Multiple Myeloma
Brief Summary

This is a multi-institution, non-randomized, open label, Phase IIa prospective trial to evaluate the safety and tolerability of maintenance lenalidomide after allogeneic hematopoietic stem cell transplantation (HCT).

Lenalidomide maintenance therapy will start between day 60 and 90 after allogeneic HCT at a starting dose of 10mg PO once daily. Dose escalation and de-escalation will be performed depending on tolerability of lenalidomide. Dose range is 5mg every other day to 5 - 25 mg given daily on days 1-21 of a 28-day cycle for 12 cycles maximum or maximum of 12 months from first dose of study drug.

Patients will be followed until 28 days from completing the 12th planned cycle of lenalidomide maintenance or 12 months from first dose of study drug, which ever comes first, (14 to 15 months after receiving the allograft) or discontinuation of study drug.

Detailed Description Not Provided
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
Intervention  ICMJE Drug: lenalidomide

Lenalidomide maintenance therapy will start within 60 to 90 days after allogeneic HCT at a starting dose of 10mg PO once daily.

Dose escalation and de-escalation are performed depending on tolerability of lenalidomide.

The dose range is 5mg every other day and 5 to 25 mg daily from days 1-21 followed by 7 days of rest for 12 cycles (each cycle 28 days).

Other Name: Revlimid
Study Arms  ICMJE Experimental: Lenalidomide
Lenalidomide maintenance therapy will start within 60 to 180 days after allogeneic HCT at a starting dose of 10mg PO once daily. Dose escalation and de-escalation are performed depending on tolerability of lenalidomide. The dose range is 5mg every other day and 5 to 25 mg daily from days 1-21 followed by 7 days of rest for 12 cycles (each cycle 28 days).
Intervention: 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: February 17, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • One prior allograft from an 8/8 or 7/8 allele matched related or unrelated donor, received 60 to 90 days prior to initiation of lenalidomide
  • Meet the diagnostic criteria of symptomatic myeloma at anytime prior to allogeneic HCT
  • Have high-risk multiple myeloma
  • Received ≤ three (3) prior lines of therapy. Prior therapies may include: combination chemotherapy, monotherapy, lenalidomide and autologous HCT. Localized radiation therapy does not count as a single line of therapy. Previous progression on lenalidomide does not exclude participation in the study.
  • Received a reduced intensity conditioning regimen
  • Received or are receiving a GVHD prophylaxis regimen of a calcineurin inhibitor in combination with either methotrexate, mycophenolate mofetil (MMF) or sirolimus
  • Karnofsky performance score ≥ 80 or ECOG ≤ 2
  • There must be at least 50% donor chimerism and no evidence of falling donor chimerism within 1 month of enrollment
  • Laboratory test results within range, within 14 days prior to initiation of lenalidomide
  • All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

Exclusion Criteria:

  • Disease progression at time of study entry
  • Patients with any grade III-IV GVHD at the time of study entry
  • Patients requiring additional immunosuppressive therapy to control acute GVHD other than corticosteroids and immunosuppressive agents used for prophylaxis.
  • Concomitant use of other investigational agents
  • Patients who have received donor lymphocyte infusions
  • Active CNS malignancy
  • Uncontrolled bacterial, viral, or fungal infections
  • Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ < 5 years from study entry.
  • Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide.
  • Known positive for HIV or active infectious hepatitis.
  • Women who are pregnant or breastfeeding.
  • New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 NCT00847639
Other Study ID Numbers  ICMJE 07-REV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Center for International Blood and Marrow Transplant Research
Study Sponsor  ICMJE Center for International Blood and Marrow Transplant Research
Collaborators  ICMJE
  • National Marrow Donor Program
  • Celgene Corporation
Investigators  ICMJE
Principal Investigator: Melissa Alsina, MD H. Lee Moffitt Cancer Center
Study Chair: Marcelo Pasquini, MD CIBMTR/ Medical College of Wisconsin
PRS Account Center for International Blood and Marrow Transplant Research
Verification Date April 2014

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