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

Doxorubicin

Liposomal doxorubicin

Bortezomib

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Patients will be treated with bortezomib at 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days (cycle).

bortezomib

Dexamethasone tablets will be given at 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days (cycle).

dexamethasone

Patients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m\^2 on Day 4 every 28 days (cycle).

doxorubicin HCl liposome

Johnetta Blakely, MD

The current study is being conducted to evaluate the possibility that a different schedule of bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib dosing for a longer period.

Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma

A Phase II, Open Label Study Evaluating an Alternative Schedule of Velcade/Dexamethasone Plus Doxil in the Treatment of Multiple Myeloma

Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and \<5% plasma cells in bone marrow. PR also required \>=50% SPEP reduction, \>=90% UPEP reduction, and \>=50% reduction in plasma cells in bone marrow. MR also required \>=25% SPEP reduction, \>=50% UPEP reduction, and \> 25% reduction in plasma cells.

Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.

Millennium Pharmaceuticals, Inc.

Accelerated Community Oncology Research Network

Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.

All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.

Treatment Group

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

The study was closed to enrollment when it became clear that enrollment was too slow to complete the planned enrollment target of 45 patients within the time frame allowed. Response rate was unable to be assessed due to missingness of required data.

Vice President of Scientific Affairs

Incidence of Treatment-emergent Peripheral Neuropathy

Time to Progression (TTP)

Number of Participants With Treatment Response

Cycle 1 / Week 1

Cycle 1 / Week 1 Day 4

Cycle 1 / Week 3

Cycle 1 / Week 3 Day 18

Cycle 2 / Week 5

Cycle 2 / Week 5 Day 4

Cycle 2 / Week 7

Cycle 2 / Week 7 Day 18

Cycle 3 / Week 9

Cycle 3 / Week 9 Day 4

Cycle 3 / Week 11

Cycle 3 / Week 11 Day 18

Cycle 4 / Week 13

Cycle 4 / Week 13 Day 4

Cycle 4 / Week 15

Cycle 4 / Week 15 Day 18

Cycle 5 / Week 17

Cycle 5 / Week 17 Day 4

Cycle 5 / Week 19

Cycle 5 / Week 19 Day 18

Cycle 6 / Week 21

Cycle 6 / Week 21 Day 4

Cycle 6 / Week 23

Cycle 6 / Week 23 Day 18

Cycle 7 / Week 25

Cycle 7 / Week 25 Day 4

Cycle 7 / Week 27

Cycle 7 / Week 27 Day 18

Cycle 8 / Week 29

Cycle 8 / Week 29 Day 4

Cycle 8 / Week 31

Cycle 8 / Week 31 Day 18

Cycle 9 / Week 33

Cycle 9 / Week 33 Day 4

Cycle 9 / Week 35

Cycle 10 / Week 37

Cycle 10 / Week 37 Day 4

Cycle 10 / Week 39

Cycle 10 / Week 39 Day 18

Cycle 11 / Week 41

Cycle 11 / Week 41 Day 4

Cycle 11 / Week 43

Cycle 11 / Week 43 Day 18

Note that the sample sized varied at each dose and ranged from 32 patients to 1 patient.

Relative Dose Intensity of Bortezomib

Overall Study

Spots Global Cancer Trial Database for Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial