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

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Anti-Inflammatory Agents

Analgesics

Cyclophosphamide

Bendamustine Hydrochloride

Bortezomib

Chloroquine

Chloroquine diphosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Amebicides

Antiprotozoal Agents

Antiparasitic Agents

Antimalarials

VELCADE given by intravenous push at 1.3 mg/m\^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.

Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.

Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.

Each cycle is 42 days in length.

Velcade

Michael Grossbard, MD

This pilot phase II trial studies how well giving bortezomib and cyclophosphamide together with chloroquine works in treating patients with relapsed or refractory multiple myeloma.

Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chloroquine may help chemotherapy drugs work better by making cancer cells more sensitive to the drug. Giving bortezomib and cyclophosphamide together with chloroquine may kill more cancer cells.

Chloroquine in Combination With VELCADE and Cyclophosphamide for Relapsed and Refractory Multiple Myeloma

A Phase II, Trial of Chloroquine in Combination With VELCADE and Cyclophosphamide in Patients With Relapsed and Refractory Myeloma

Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria:

CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow PR: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h

Adverse events reported here were at least possibly related to the protocol therapy.

Duration of response is the time from response (CR or PR) until progression of disease or relapse. Responses and progression were evaluated based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006).

Millennium Pharmaceuticals, Inc.

NYU Langone Health

All adverse events were reported regardless of attribution to protocol therapy.

Velcade+Cyclophosphamide+Chloroquine

45-53 years

54-63 years

64-73 years

74-83 years

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Amitabha Mazumder, MD

Response Rate (CR + PR After 2 Cycles)

Fatigue

Hemoglobin

Nasal cavity/paranasal reactions

ANC/AGC

Pain: pleural

Platelets

Number of Participants With Adverse Events of Grade 3 or Higher

Study was terminated prior to collection of this data point.

Percentage of Subjects Who Have Complete Response or Partial Response and Have 2+ or Higher Autophagy

Median Duration of Response of This Regimen

Overall Study

Spots Global Cancer Trial Database for Chloroquine in Combination With VELCADE and Cyclophosphamide for Relapsed and Refractory Multiple Myeloma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial