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

NCT ID: NCT00847639

Last Updated: 2014-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2014-03-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

lenalidomide

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Revlimid

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Marrow Donor Program

OTHER

Sponsor Role: collaborator

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Center for International Blood and Marrow Transplant Research

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Alsina, MD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center

Marcelo Pasquini, MD

Role: STUDY_CHAIR

CIBMTR/ Medical College of Wisconsin

Locations

City of Hope National Medical Center

Duarte, California, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

University of Pennsylvania Hospital Center

Philadelphia, Pennsylvania, United States

The University of Texas, M.D. Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

07-REV

Identifier Type: -

Identifier Source: org_study_id