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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00849251
Other study ID # 6817
Secondary ID NCI-2009-01665
Status Terminated
Phase Phase 1/Phase 2
First received February 20, 2009
Last updated September 17, 2015
Start date November 2008
Est. completion date June 2015

Study information

Verified date September 2015
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving pegylated liposomal doxorubicin hydrochloride together with bortezomib, cyclophosphamide, and dexamethasone may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects of giving pegylated liposomal doxorubicin hydrochloride together with bortezomib, cyclophosphamide, and dexamethasone and to see how well it works in treating patients with multiple myeloma


Description:

PRIMARY OBJECTIVES:

I. To determine efficacy of this novel combination in newly diagnosed patients with multiple myeloma.

SECONDARY OBJECTIVES:

I. To determine the toxicity of this novel combination regimen in previously treated patients and newly diagnosed patients with multiple myeloma.

OUTLINE:

Patients receive cyclophosphamide intravenously (IV) or orally (PO) over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of treatment, patients are followed up every 3 months.


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date June 2015
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Cohort 1: Relapsed, refractory patients with multiple myeloma who have failed at least one prior regimen not including dexamethasone alone

- Cohort 2: Newly diagnosed patients with previously untreated multiple myeloma; prior dexamethasone permitted; not to exceed 320 mg

- Diagnosis of multiple myeloma with quantifiable monoclonal protein or light chain identified by serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), or serum free light chain assay

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Absolute neutrophil count >= 1.5

- Platelet count >= 75,000 unless slightly lower due to disease with the approval of the principal investigator (PI)

- Serum creatinine =< 2.0 mg/dL

- Serum bilirubin =< 1.2

- Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x upper limit of normal (ULN)

- Alkaline phosphatase =< 2.5 x ULN

- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

- Left ventricular ejection fraction greater than or equal to 50% by multi gated acquisition scan (MUGA)

- Female subjects must be post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study; female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment

- Male patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment

Exclusion Criteria:

- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol

- Use of other anticancer therapy within 15 days or before study entry; the patient must have recovered from all acute non-hematological toxicities from any previous therapy

- Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment, despite appropriate antibiotics or other treatment; for cardiac dysfunction, myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities

- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection) on antiviral, antibiotic and antifungal treatment

- Patient has >= Grade 2 peripheral neuropathy within 14 days before enrollment

- Patient has hypersensitivity to bortezomib, boron or mannitol

- Pregnant or lactating patients

- Cumulative dose of doxorubicin of 400 mg/m^2 or greater, or if this level would be exceeded during the current study

- Any significant concurrent illness, condition, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results

- Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy including the following:

- Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed;

- Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed;

- Prior autologous stem cell transplant (Cohort 2 only);

- Prior allogeneic stem cell transplant;

- Patient has received other investigational drugs within 14 days before enrollment

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
cyclophosphamide
Given IV or PO
pegylated liposomal doxorubicin hydrochloride
Given IV
bortezomib
Given IV
dexamethasone
Given IV or PO

Locations

Country Name City State
United States Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose of this combination of drugs as assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (cohort 1) If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Before each drug dose Yes
Primary Response rate (complete remission [CR] or near CR) (cohort II) At the beginning of each course No
See also
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Terminated NCT02020941 - Carfilzomib in Treating Patients With Multiple Myeloma in First Relapse or Refractory to First-Line Therapy Phase 2
Completed NCT01775553 - Study of High Dose Carfilzomib in Multiple Myeloma Patients Who Have Progressed On Standard Dose Carfilzomib Phase 2
Completed NCT01212952 - Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Phase 1/Phase 2
Completed NCT01233921 - Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer N/A
Terminated NCT01078441 - Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant Phase 2
Completed NCT00514137 - Sunitinib in Treating Patients With Relapsed Multiple Myeloma Phase 2
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Completed NCT00047203 - Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma Phase 2
Active, not recruiting NCT03731832 - Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma Phase 2
Completed NCT00003196 - Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma N/A
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Recruiting NCT04302324 - A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab Phase 2
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Completed NCT00118170 - Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin's Lymphoma With or Without Impaired Liver or Kidney Function Phase 1
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