West Cancer Center

MULTIPLE MYELOMA: Relapsed/Refractory: >/=3rd line: "TH-CR-408"

A phase 1/2 open-label study to assess the safety, tolerability and preliminary efficacy of TH-302, a hypoxia-activated pro-drug, and dexamethasone with or without bortezomib in subjects with relapsed/refractory multiple myeloma

Title

Threshold TH-CR-408

Study Title

Site Link

NCT01522872

Malignancy

Multiple Myeloma, Plasma Cell Myeloma

Stage

N/A

Disease Setting

Relapsed/Refractory

Line Of Therapy

>/=3rd

Investigational Agent

TH-302

Drug Class

hypoxia activated pro-drug

Michael Martin, MD

Sponsor

Threshold Pharmaceuticals

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01522872?term=TH-CR-408&rank=1

Key Eligibility Criteria Details

Relapsed/refractory myeloma with at least 2 prior therapies
Measurable disease by M-protein, FLC, or plasmacytoma
ECOG PS 0-2
Acceptable renal, marrow, hepatic, cardiac fxn
No non-secretory disease
No POEMS syndrome or amyloidosis
No plasma cell leukemia or Waldenstroms
No symptomatic CNS disease
No recent high dose steroid use_

Objective

Primary- safety/tolerability: Secondary- ORR, PFS, PK, relationship of response to marrow hypoxia

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Dosing Frequency

TH-302 at decided dose, bortezomib 1.3 mg/m2

Control Agents

N/A

Study Protocol

Randomized