SWOG clinical trial number
S0340

A Prospective Observational Study of Patients with Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan

Closed
Phase
Accrual
2%
Abbreviated Title
Solitary Plasmacytoma
Activated
04/15/2005
Closed
02/15/2007
Participants
NCORP, Members, Medical Oncologists, Radiation Oncologists, Pathologists

Research committees

Myeloma

Eligibility Criteria Expand/Collapse

Pts must have tissue biopsy proven solitary bone plasmacytoma or extraosseous solitary plasmacytoma. Pts must have no lytic lesions on skeletal survey other than single lesion associated with solitary plasmacytoma within 28 days prior to registration. Skeletal surveys must be planned to be submitted for central review prior to registration; however, completion of central review is not required prior to registration. Pts must have bone marrow plasmacytosis of less than 10% within 28 days prior to registration. Pts must have low serum and/or urine M-protein per the protocol guidelines within 14 days prior to registration. Pts must have adequate organ function per the protocol guidelines within 14 days prior to registration. All MRIs conducted for this study must be performed on MRI machine(s) with magnetic strength greater than or equal to 1 Tesla. Pts must not have received any prior therapy for myeloma except surgery or localized radiation. Prior high dose steroids are not allowed except to relieve neurological compromise. Pts must be greater than or equal to 18 years of age at the time of registration. Zubrod PS 0-2. Pts must be registered on S0309. No other prior malignancy is allowed except for the following: adequately treated basal cell or sqamous cell skin cancer, in situ cervical cancer, in situ breast cancer, adequately treated Stage I or II cancer from which the pt is currently in complete remission, or any other cancer from which the pt has been disease-free for 5 years. Institutions must have IRB approval of S0334. Pts must be offered participation in S0334.