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

Phase 2
18 Years
70 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

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

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

- 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

- 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.

Type of Study:


Study Design:

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

Outcome 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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Melissa Alsina, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • lenalidomide
  • Revlimid
  • Allogeneic Hematopoietic Cell Transplantation
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Medical College of WisconsinMilwaukee, Wisconsin  53226
Hackensack University Medical CenterHackensack, New Jersey  07601
City of Hope National Medical CenterLos Angeles, California  91010
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
University of Minnesota Medical CenterMinneapolis, Minnesota  55455
The University of Texas, M.D. Anderson Cancer CenterHouston, Texas  77030
University of Pennsylvania Hospital CenterPhiladelphia, Pennsylvania  19104