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

Multiple Myeloma Clinical Trial

— 07-REV  

Official title:

Evaluation of Lenalidomide as Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for High-risk Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847639
• Other study ID #: 07-REV
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2009
• Last updated: April 2, 2014
• Start date: February 2009
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Center for International Blood and Marrow Transplant Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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).

Locations

Country	Name	City	State
United States	City of Hope National Medical Center	Duarte	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The University of Texas, M.D. Anderson Cancer Center	Houston	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	University of Pennsylvania Hospital Center	Philadelphia	Pennsylvania
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Center for International Blood and Marrow Transplant Research	Celgene Corporation, National Marrow Donor Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months	Yes
Secondary	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.		13 months	Yes
Secondary	To measure the overall response and best response rates to lenalidomide maintenance therapy following allogeneic HCT.		13 Months	Yes
Secondary	To determine time to disease progression and overall survival after lenalidomide.		13 months	Yes