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

Sponsor:	Center for International Blood and Marrow Transplant Research
Collaborators:	National Marrow Donor Program Celgene Corporation
Information provided by (Responsible Party):	Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:	NCT00847639

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: lenalidomide	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of Lenalidomide as Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for High-risk Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Lenalidomide

U.S. FDA Resources

Further study details as provided by Center for International Blood and Marrow Transplant Research:

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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
To measure the overall response and best response rates to lenalidomide maintenance therapy following allogeneic HCT. [ Time Frame: 13 Months ] [ Designated as safety issue: Yes ]
To determine time to disease progression and overall survival after lenalidomide. [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	February 2009
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847639

Locations

United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, Pennsylvania
University of Pennsylvania Hospital Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98195
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Center for International Blood and Marrow Transplant Research

National Marrow Donor Program

Celgene Corporation

Investigators

Principal Investigator:	Melissa Alsina, MD	H. Lee Moffitt Cancer Center
Study Chair:	Marcelo Pasquini, MD	CIBMTR/ Medical College of Wisconsin

More Information

No publications provided

Responsible Party:	Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:	NCT00847639 History of Changes
Other Study ID Numbers:	07-REV
Study First Received:	February 17, 2009
Last Updated:	January 19, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Center for International Blood and Marrow Transplant Research:

Multiple Myeloma
lenalidomide
Revlimid
Allogeneic Hematopoietic Cell Transplantation

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide

Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 24, 2012