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The links after "Participants" show which SWOG institutions are eligible to participate in this study.

The orange "Where is This Study Open?" tab at the bottom of the page shows the institutions whose Institutional Review Boards (IRBs) have approved the protocol so that it can be opened at that institution. Clicking on the Institution Name will show the points of contact for information about this study at that institution.

S0115 - Phase II

Status Notes: This study will be permanently closed effective 11:59 p.m. on November 1, 2010.

A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m2) And Autologous Peripheral Blood Stem Cell Supported Transplantation (SCT) For Patients with AL Amyloidosis or High Risk (greater than or equal to Age 70 or Poor Renal Function)Patients With Multiple Myeloma(A BMT Study)
Treatment: Cyclophosphamide, Dexamethasone, Filgrastim, Melphalan, Mesna, Thalidomide

Research Committee: Myeloma

Study Coordinator(s): Vaishali Sanchorawala, M.D., David C. Seldin, M.D.,Ph.D.

Participants: Members, CCOP, Medical Oncologists, Limited Institutions: BMT Members

Eligibility Criteria: Pts must have been diagnosed with Stage II or III multiple myeloma (MM) within one year prior to registration. Pts with IgM peaks are not eligible except if the patient has criteria to support the diagnosis of multiple myeloma such as bony lesions, myeloma kidney-cast nephropathy, the absence of adenopathy (unless plasma cell infiltration). Pts with MGUS, indolent or smoldering myeloma are not eligible. AND / OR Pts must have a histological diagnosis of primary systemic (AL) amyloidosis AND/OR Light Chain Deposition Disease (LCDD) as per protocol. Pts with severe cardiac involvement are not eligible as per protocol. Pts with senile, secondary, localized, dialysis-related or familial amyloidosis are not eligible. Necessary baseline studies to determine eligibility must be obtained within 28 days prior to registration. X-rays, scans, and bone marrow biopsy must be completed within 42 days prior to registration. All pts must be greater than or equal to 18 years old. Pts with MM only must be greater than or equal to 70 years old or greater than or equal to 18 years old for those meeting criteria for poor renal function, as defined in the protocol. Renal function assessment must be completed within 28 days prior to registration. Dialysis is not an exclusion. Prior tx for MM or AL or LCDD is allowed. Prior cumulative melphalan dose must be less than 200 mg. Prior and current bisphosphonates therapy is allowed. Pts must have recovered from all treatment related toxicities prior to registration. Pts who have previously been treated with either thalidomide or dexamethasone and who have not responded or who have progressed per the protocol on either of these agents are considered refractory and are not eligible. Zubrod PS of 0-2. Pts must have an ANC greater than or equal to 1,000/µl and platelet count greater than or equal to 100,000/µl obtained within 28 days prior to registration. Pts must have a bilirubin and SGOT or SGPT less than or equal to 2.5 x the IULN, obtained within 28 days prior to registration. Pts must have a LVEF by ECHO or MUGA greater than 45% performed within 42 days prior to registration. Pts with recent (less than 6 months) myocardial infarction, congestive heart failure or arrhythmia refractory to medical therapy are not eligible. AL pts with severe cardiac involvement as per the protocol are not eligible. Pts must have a systolic bp greater than 90 mm Hg in a lying position within 42 days prior to registration. There must be no plans for pts to receive concomitant RT, hormonal therapy, or other chemotherapy while on this protocol. Pts must have a negative HIV test within 6 months of registration. Institutions must have IRB approval of S0309, the myeloma repository protocol. Pts must be offered participation in S0309. No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical 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. Pts must not be pregnant or nursing. Pts of reproductive potential must have agreed to use an effective contraceptive method. MM pts must be fully aware of the teratogenic potential of thalidomde and agree to fully comply with the guidelines regarding contraception in the informed consent and the pt warning letter attached to the consent form. Pts must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program. Pts must have evidence of financial coverage for tandem transplant (exception: Medicare pts must have evidence of financial coverage for only the first transplant). Institutions are strongly urged to submit a local prestudy cytogenetics and FISH analaysis report for any patients with myeloma. Stem cell collection must be planned to be performed at a Southwest Oncology Group approved BMT facility. The designated Southwest Oncology Group approved transplant facility must have been notified of the potential patient and the BMT institution name provided at the time of registration.

Activation Date: 1/1/2004

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