Each tablet will contain 27 mg of 98% pure genistein + 500mg Calcium + 200 IU Vit. D3. Subjects will receive 2 tablets per day 6 days/week for all the duration of the study.
Once a week subjects will receive a tablet containing only 500mg Calcium + 200 IU Vit. D3.

Each tablet will contain 500mg Calcium + 200 IU Vit. D3. Subjects will receive 2 tablets per day 6 days/week for all the duration of the study.
Once a week subjects will take one tablet containing 70mg alendronate.

Osteoporosis, Steroid Induced

Only female XX patients will be included, to avoid interactions with other steroid drugs.

Genistein aglycone

Alendronate Oral Tablet

500mg Calcium + 200 IU Vitamin D3 bid in tablets

Calcium + vitamin D3 tablet

University of Messina

University Hospital

Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

Metabolic, Endocrine, and Central Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

BMD of lumbar spine and femoral will be measured by DEXA (dual energy x-ray absorptiometry)

Xrays of the lumbar spine (T4-L4) will be taken to evaluate the presence of fractures

pQCT (peripheral quantitative computed tomography) will be used for bone quality evaluation

bone turnover markers will be evaluated on peripheral blood

Markers of cardiovascular risk will be evaluated on peripheral blood

Glycaemia and blood lipids will be evaluated on peripheral blood

European Quality of Life Questionnaire will be administered to subjects

skin elasticity will be tested in subjects taking glucocorticoids

markers of thyroid function will be evaluated on peripheral blood

markers of inflammation will be evaluated on peripheral blood

Estrogen receptor polymorphisms will be evaluated on white blood cells

Francesco Squadrito

Full Professor of Pharmacology

Ministry of Health, Italy

Drugs will be labelled as "A" and "B" and so will be the groups. Patients and doctors involved will not be aware of the treatment.

Myeloma

100 mg QD continuously (from day 1 to day 28)

dasatinib

0,18 mg/Kg/day from day 1 to day 4 for 6 cycles

melphalan

1,5 mg/Kg/day from day 1 to day 4 for 6 cycles

prednisone

Mario Boccadoro

Dasatinib in Combination With Melphalan and Prednisone to Treat Relapsed and Refractory Multiple Myeloma Patients

A Multicenter, Open-label, Phase Ii Study of Dasatinib in Combination With Melphalan and Prednisone (D-MP) in Advanced, Relapsed / Refractory Multiple Myeloma Patients

Evaluation of tumor status will be conducted at screening and anti-tumor treatment efficacy will be assessed at every cycle according to the International Uniform Criteria for Response in MM.
Safety and tolerability are a co-primary endpoint: incidence of grade 3-4 toxicities will support the decision to move to stage 2, together with PR rate once all the patients accrued to the first stage are evaluable.

Prof. Mario Boccadoro

Fondazione Neoplasie Sangue Onlus

Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.

Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.

Dasatinib

Sex: Female, Male

Region of Enrollment

Stage I: Hemoglobin (Hb) > 10g/dL, normal calcium, normal or single plasmacytoma or osteoporosis, Serum paraprotein level < 5 g/dL if IgG, < 3 g/dL if IgA, Urinary light chain excretion < 4 g/24h Stage 2: Not fufilling criteria of Stage I or III Stage III: Hb < 8.5g/dL, calcium > 12 mg/dL, 3 or more lytic bone lesions, Serum paraprotein > 7g/dL if IgG, > 5 g/dL if IgA, Urinary light chain excretion > 12g/24h
Stages I, II, and III can be divided into A or B depending on serum creatinine:
A: serum creatinine < 2 mg/dL (< 177 μmol/L) B: serum creatinine > 2 mg/dL (> 177 μmol/L)

Durie-Salmon Stage

Prior therapies

Beta 2 microglobulin at study entry

Disease status at study entry

Paraprotein

Cytogenetics

CR requires all of the following:
Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune response reconstitution does not exclude CR.
< 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow.
No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response).
Disappearance of soft tissue plasmacytoma
PR requires all of the following:
50% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks.
-Reduction in 24 hr urinary light chain excretion by either > 90% or to < 200 mg, maintained for a minimum of 6 weeks.
50% reduction in the size of soft tissue plas

Dasatinib 70 mg BID

In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.

Dasatinib 100 mg BID

Response Rate [Complete Response (CR) and Partial Response (PR)]

Time to response is measured from the start of treatment until the first date that criteria are met for complete response or partial response.

Time to Response

Toxicities were graded using the NCI Common Toxicity Criteria v3.0.

Safety and Tolerability of Dasatinib (Grade III-IV Toxicities)

Duration of response is measured from the first date that criteria are met for complete response or partial response until the first date that criteria for relapse or progressive disease are met.

Duration of Response

EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.

Event-free Survival (EFS) for Participants With Plateau Phase Disease

Event-free Survival (EFS) for Participants With Relapsed Disease

Overall Study

Ravi Vij, M.D.

Relapsed, Refractory or Plateau Phase Multiple Myeloma

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

bone resorption/tyrosine

Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

Dasatinib in Combination With Melphalan and Prednisone to Treat Relapsed and Refractory Multiple Myeloma Patients

A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma

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