Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Dexamethasone

Bortezomib

Dexamethasone acetate

BB 1101

Pasireotide

Dexamethasone 21-phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

60 mg intramuscularly (IM) on day 1 of each 28 day cycle

SOM230

1.3 mg/m2 intravenously (IV) on days 1, 4, 8, and 11 of each cycle. Bortezomib will be infused by IV push.

20 mg orally on day of and day after bortezomib (Days 1, 2, 4, 5, 8, 9, 11, 12).

The purpose of this study is to determine if adding SOM230 LAR to bortezomib and dexamethasone is better than bortezomib and dexamethasone alone and if it should be investigated further.

SOM230 LAR With Bortezomib and Dexamethasone for Refractory or Relapsed Multiple Myeloma

Phase II Study of SOM230 LAR in Combination With Bortezomib and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma

Responses (CR and PR) and incidence of SD will be tabulated by disease diagnosis. All responses will be reported. Response rate among patients with measurable disease will be summarized by exact binomial confidence intervals.

The progression free survival function will be estimated by means of the product limit (Kaplan-Meier) esitmator with 95% confidence interval. Median PFS will be estimated from the survival function.

Type, incidence severity (NCI-CTCAE grade), timing, relatedness of AE and laboratory abnormalities will be tabulated, with 95% confidence intervals, as appropriate.

Serum bone resorption markers, calcium, MIP-1alpha, TRACP-5b, serum (NTx), and serum C-terminal telopeptide (CTx) will be compared to circulating IGF-1 graphically (by scatterplots) and by Pearson or Spearman correlation coefficients, depending on the graphical assessment.

Serum bone resorption markers will be measured during pretreatment and on day 1 of each cycle. Their change over time will be characterized by estimates derived from a mixed effects ANOVA model.

To analyze whether bortezomib/SOM230 LAR treatment can restore the balance between OCL and osteoblast activity, bone marrow samples will be obtained before treatment and during treatment (day 11 of cycle 2) for OCL formation assays. Mean change over time will be estimated with 95% confidence intervals, and the null hypothesis of no change tested with a paired-comparison t-test

Novartis

University of Pittsburgh

Spots Global Cancer Trial Database for SOM230 LAR With Bortezomib and Dexamethasone for Refractory or Relapsed Multiple Myeloma

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Interventions

Study Description

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