Clinical trial NCT00847639: Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma
Official title: Evaluation of Lenalidomide as Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for High-risk Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
lenalidomide
Revlimid
Allogeneic Hematopoietic Cell Transplantation
Lead sponsor: Center for International Blood and Marrow Transplant Research
Sponsor class: NETWORK
Collaborators: name: National Marrow Donor Program
name: Celgene Corporation
First posted: 2009-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 13 months
measure: To measure the overall response and best response rates to lenalidomide maintenance therapy following allogeneic HCT.
timeFrame: 13 Months
measure: To determine time to disease progression and overall survival after lenalidomide.
timeFrame: 13 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital Center
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas, M.D. Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: H. Lee Moffitt Cancer Center
name: Melissa Alsina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIBMTR/ Medical College of Wisconsin
name: Marcelo Pasquini, MD
role: STUDY_CHAIR
References: