A Phase II Study of Dexamethasone (DECADRON®), Thalidomide (THALOMID®), and Lenalidomide (REVLIMID®) for Subjects With Relapsed or Refractory Multiple Myeloma
This phase II study is a treatment program for patients with relapsed or refractory multiple
myeloma who have had prior treatment with both thalidomide and lenalidomide in separate
regimens each used as a single agent or in combination with corticosteroids. Up to 45
patients will be enrolled. Patients who sign informed consent form and RevAssist® and
S.T.E.P.S® patient agreement form and fulfill all eligibility criteria will be enrolled.
- Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.
- Thalidomide will be given 50mg daily on days 1-7, thereafter 100mg daily on days 8-28
of the first 28-day cycle. Thalidomide will then be given at 100mg/daily for days 1-28
of each subsequent cycle.
- Lenalidomide will be given 25mg daily for days 1-21 of each 28 day cycle.
- Prophylactic medications, such as medications for thrombosis risk, will be given.
After completing 4 cycles:
- Patients who demonstrate disease progression at any time will be taken off study.
- Patients who achieve a resolution of monoclonal gammopathy as detected on serum
immunofixation or achieve a plateau of disease (no change in M-spike as detected on
serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance
- Patients who continue to respond without achieving either a plateau or a CR will
continue on induction therapy until plateau for >2 cycles or CR in the absence of
untoward toxicity. These patients will be then transitioned to maintenance therapy.
Maintenance therapy will consist of:
- Dexamethasone 20mg weekly days 1, 8, 15, 22 out of a 28 day cycle)
- Lenalidomide 25 mg/daily days 1 - 21 out of a 28 day cycle. 15mg/daily on days 1-21 of
a 28 day cycle of lenalidomide will be given to patients with a creatinine clearance of
- Patients who finished induction therapy with DexTR at a reduced dose of
lenalidomide will start maintenance therapy at the same dose of lenalidomide on
which they ended induction therapy. For patients with a creatinine clearance of <
40cc / minute, the lenalidomide dose will be the lower of their last induction
therapy dose or 15mg daily on days 1 - 21 out of a 28 day cycle.
Serial clinic visits and laboratory measurements will be performed to monitor for treatment
response. Those patients who demonstrate progression of disease at any point during DexTR
therapy will be taken off study.
At the end of every cycle (which may coincide with day 1 of the new cycle), response and
toxicity will be evaluated. During cycle 1, patients will have lab work done weekly (CBC
with differential and blood electrolytes). All patients will remain on study until disease
progression or side effects become excessive. Patients who achieve a stable plateau and are
on maintenance therapy as defined above may be taken off study if eligible to proceed to
high dose chemotherapy and autologous stem cell transplantation.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
effect of drug combination on multiple myeloma
duration of study
Ruben Niesvizky, MD
Weill Medical College of Cornell University
United States: Institutional Review Board
|Weill Medical College of Cornell University||New York, New York 10021|