A Phase 2 Study of Lenalidomide and Low-dose Dexamethasone in Combination With Dalteparin in Previously Untreated Multiple Myeloma
I. To select a dose of Dalteparin to be used with Lenalidomide and low-dose dexamethasone in
future trials for patients with previously untreated multiple myeloma (MM), based on
toxicity, selected biomarkers (M-spike, interleukin [IL]-6) related to response and other
markers of coagulation.
I. To evaluate overall response rate (ORR = complete response [CR] + partial response [PR]),
and time to progression (TTP) for this regimen at each of the two Dalteparin doses.
II. To evaluate the safety profile of this regimen in untreated MM patients, at each of the
two Dalteparin doses.
III. To study the effect of Dalteparin alone, and in combination with
lenalidomide/dexamethasone on serum biomarkers of multiple myeloma (MM) and thrombosis.
IV. To explore possible associations between the ORR and incidence of venous thromboembolism
(VTE) with serial syndecan-1, IL-6, tyrosine aminotransferase (TAT), D-dimer, P-selectin
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive a
prophylactic dose of dalteparin subcutaneously (SC) on days 1-28; lenalidomide orally (PO)
on days 1-21; and low-dose dexamethasone PO on days 1, 8, 15, and 22.
ARM II: Patients receive a therapeutic dose of dalteparin SC on days 1-21 and lenalidomide
PO and low-dose dexamethasone PO as in Arm I.
In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity. Patients with residual responding disease may receive
2 additional courses. After completion of study treatment, patients are followed up every
3 months for up to 2 years.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients who experienced grade 4 hemorrhage regardless of attribution, or grade 3 hemorrhage that is possibly, probably, or definitely attributable to dalteparin (Arm II)
Up to 2 years
USC/Norris Comprehensive Cancer Center
United States: Federal Government
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