Trial intelligence / Profile preview

Dalteparin with Lenalidomide and Dexamethasone in Previously Untreated Multiple Myeloma

NCT01518465Phase 2

Key facts

Status: Terminated
Start: Jan 2012
Primary completion: Dec 2016
Countries: 1
Sponsor: University of Southern California
Modality: Recombinant Proteins and Enzymes

Drugs: dalteparin
Conditions: multiple myeloma (MM)

Overview

Phase 2, randomised, open-label trial of dalteparin in multiple myeloma (MM) (2 arms), sponsored by University of Southern California. Primary endpoint: Number of patients who experienced grade 4 hemorrhage up to 2 years. Started Jan 2012; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

Prophylactic Dalteparin
Dalteparin 5000 IU SC + Lenalidomide + Dexamethasone
Therapeutic Dalteparin
Dalteparin 200 IU/kg SC + Lenalidomide + Dexamethasone

Who it enrols

Patients with previously untreated active multiple myeloma, ECOG < 2, and adequate organ function. Excludes patients with prior chemotherapy for MM, active serious infections, or HIV.

Endpoints

Primary

Number of patients who experienced grade 4 hemorrhageUp to 2 years

Secondary

Overall Response RateUp to 2 years
Time to ProgressionUp to 2 years
Toxicities observed at each dose levelUp to 2 years
Serum biomarkers of multiple myeloma and thrombosisUp to 2 years

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