Multiple Myeloma
Conditions
Brief summary
AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma
Interventions
DRUGimexon
Sponsors
AmpliMed Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced myeloma, with measurable disease as defined in the protocol. * Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products. * Able to perform the activities of daily living. * Off prior therapy for at least 2-4 weeks depending on the drug. * Blood counts and blood chemistries in or near normal range. * If female, neither pregnant nor nursing. * Willing to use contraceptives to prevent pregnancy. * No other serious illnesses. * No other active malignancy. * No serious infections. * No current other drug therapy for the myeloma except for steroid therapy under certain circumstances. Biphosphonate therapy is permitted. * Prior radiation is permitted.
Exclusion criteria
* Use of corticosteroids for amyloid disorders, or high dose chronic steroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the maximally tolerated dose of imexon in multiple myeloma patients | — |
| evaluate the toxicity of imexon | — |
| Preliminarily evaluate efficacy in terms of response and progression free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate biomarker responses. | — |
Countries
United States
Outcome results
None listed