A phase 1b/2 trial to evaluate the safety and efficacy of radium-223 dichloride (BAY 88-8223) in combination with bortezomib and dexamethasone in early relapsed multiple myeloma

Protocol: 
AAAQ7131
Phase: 
I/II

A phase 1b/2 trial to evaluate the safety and efficacy of radium-223 dichloride (BAY 88-8223) in combination with bortezomib and dexamethasone in early relapsed multiple myeloma

The main goals of this study are to evaluate the safety of the combination of the study drug radium-223 dichloride plus bortezomib and dexamethasone and to determine the optimal dose of radium-223 dichloride to be used in combination with bortezomib and dexamethasone. Radium-223 dichloride has been approved in some countries for treatment of patients with prostate cancer with bone metastases, but has not been approved yet in patients with multiple myeloma. Radium-223 dichloride is a radioactive drug, that is administered through the vein and that is taken up by bones after it is injected into the body. It works by giving off radioactivity, which is thought to kill the tumor cells that have spread to the bone. Radium-223 dichloride mainly releases a type of radioactivity that travels a very short distance. As a result, most of the effects of the drug are limited to the bones, which is the main location where multiple myeloma causes lesions.

Are you Eligible? (Inclusion Criteria)

1. Males or females ≥18 years of age
2. Have provided written informed consent. Subjects must be able to
understand and be
willing to sign the written informed consent, expressing their willingness
and ability to comply with protocol-required treatment and assessment
schedule, including follow-up
visits. A signed ICF must be appropriately obtained prior to the conduct of
any
trial-specific procedure.
3. Subject must have documented monoclonal plasma cells as defined by their
institutional standard in the bone marrow >=10% at some point in their
disease history
or presence of a biopsy proven plasmacytoma
4. Subjects must have received at least 1 and not more than 3 previous lines
of treatment
and have had a response to treatment (i.e., achieved a minimal response [MR]
or
better) according to the IMWG uniform response criteria
5. Subject must be non-refractory to bortezomib or another PI, like ixazomib
and
carfilzomib (Refractory is defined: progression of disease while receiving
bortezomib
therapy or within 60 days of ending bortezomib therapy or another proteasome
inhibitor therapy, like ixazomib and carfilzomib)

Specialty Area(s)