search
Back to results

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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lenalidomide
Sponsored by
Center for International Blood and Marrow Transplant Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, lenalidomide, Revlimid, Allogeneic Hematopoietic Cell Transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope National Medical Center
  • H. Lee Moffitt Cancer Center & Research Institute
  • University of Minnesota Medical Center
  • Hackensack University Medical Center
  • University of Pennsylvania Hospital Center
  • The University of Texas, M.D. Anderson Cancer Center
  • Fred Hutchinson Cancer Research Center
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenalidomide

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
To measure the overall response and best response rates to lenalidomide maintenance therapy following allogeneic HCT.
To determine time to disease progression and overall survival after lenalidomide.

Full Information

First Posted
February 17, 2009
Last Updated
April 2, 2014
Sponsor
Center for International Blood and Marrow Transplant Research
Collaborators
National Marrow Donor Program, Celgene Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00847639
Brief Title
Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma
Acronym
07-REV
Official Title
Evaluation of Lenalidomide as Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for High-risk Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for International Blood and Marrow Transplant Research
Collaborators
National Marrow Donor Program, Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, lenalidomide, Revlimid, Allogeneic Hematopoietic Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To measure the overall response and best response rates to lenalidomide maintenance therapy following allogeneic HCT.
Time Frame
13 Months
Title
To determine time to disease progression and overall survival after lenalidomide.
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Alsina, MD
Organizational Affiliation
H. Lee Moffitt Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcelo Pasquini, MD
Organizational Affiliation
CIBMTR/ Medical College of Wisconsin
Official's Role
Study Chair
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of Pennsylvania Hospital Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The University of Texas, M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma

We'll reach out to this number within 24 hrs