NCT01518465

Dalteparin, Lenalidomide, and Low-Dose Dexamethasone in Treating Patients With Previously Untreated Multiple Myeloma

A Phase 2 Study of Lenalidomide and Low-dose Dexamethasone in Combination With Dalteparin in Previously Untreated Multiple Myeloma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot phase II trial studies how well giving dalteparin, lenalidomide, and low-dose dexamethasone together works in treating patients with previously untreated multiple myeloma. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with lenalidomide and dexamethasone for multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dalteparin, lenalidomide, and dexamethasone together may be an effective treatment for multiple myeloma

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 levels. 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.

Conditions

• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

Interventions

Type	Name	Description
DRUG	dalteparin	Given SC
DRUG	lenalidomide	Given PO
DRUG	dexamethasone	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-01-09
• Primary completion: 2016-12-31
• Completion: 2017-10-31
• First posted: 2012-01-26
• Last updated: 2017-11-29

Locations

1 site across 1 country: United States