NCT02372240

A Study of VLX1570 and Dexamethasone in Myeloma Patients

VLX1570 and Low-Dose Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma: A Clinical and Correlative Phase 1/2 Study

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Vivolux AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2 single arm study to determine the safety and efficacy of VLX1570 IV infusion administered with low dose dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma.

Detailed description

This is a phase 1/2, open label study to determine the safety and efficacy of VLX1570 intravenous (IV) infusion administered with low dose dexamethasone on days 1, 2, 8, 9, 15, 16 of a 28-day cycle in patients with confirmed diagnosis of multiple myeloma with relapsed or relapsed and refractory disease (RRMM). The phase 1 trial design follows an Initial Accelerated Titration design followed by a traditional "3+3" cohort design to establish maximum tolerated dose (MTD) and recommended phase 2 dose (RPTD) for the phase 2 portion of the study. It is anticipated that patients will receive 6 treatment cycles. In the absence of unacceptable toxicity and disease progression, patients have the option of continuing treatment beyond 6 cycles, if the investigator determines that the patient may benefit further from it.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	VLX1570 and dexamethasone

Timeline

• Start date: 2015-04-08
• Primary completion: 2017-05-24
• Completion: 2017-05-24
• First posted: 2015-02-26
• Last updated: 2018-05-11

Locations

1 site across 1 country: United States