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Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in Multiple Myeloma

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status and phase

Completed
Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Bortezomib
Drug: filgrastim
Drug: liposomal doxorubicin
Drug: dexamethasone
Drug: cyclophoshamide

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00148317
0504007841

Details and patient eligibility

About

PRIMARY STUDY OBJECTIVES

  • To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients:

    1. Patients post first line therapy
    2. Patients with relapsed/refractory disease who are bortezomib-naïve
  • To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma.

SECONDARY STUDY OBJECTIVES

  • To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect > 10 x 106 CD34+ cells/kg in < 7 collections (for both subsets of multiple myeloma patients).
  • To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients).

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject must voluntarily sign and understand written informed consent.

  • Confirmed diagnosis of multiple myeloma as specified by the SWOG criteria and is detailed in Appendix I.

  • Measurable disease as defined the following:

    1. For patients post induction therapy, any measurable paraprotein in the serum or urine and/or any plasmacytoma present on physical exam or imaging.
    2. For patients with relapsed/refractory disease, > 0.5 g/dL serum monoclonal protein, > 0.1 g/dL serum free light chains, > 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
  • Age > or = than 18 years at the time of signing the informed consent form.

  • Karnofsky performance status> or =70% (>60% if due to bony involvement of myeloma).

  • Group A (post-induction therapy)- patients who have received only one prior treatment regimen (eg VAD, Thal/Dex, BLT-D, MP, BiRD, or DVd) with at least 20 patients having received a Revlimid based regimen or Group B(>1st line of therapy)- patients with relapsed/refractory multiple myeloma who have received two or more prior treatment regimens .

  • If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study and must use effective contraception throughout the course of the study.

  • Life expectancy > 12 weeks.

  • Absolute neutrophil count (ANC)> or = 1500 cells/mm3 (> or = 1000 for patients with bone marrow biopsy displaying > 50% involvement by myeloma)

  • Platelets count > or = 50,000/mm3 (> or = 30,000 for patients with bone marrow biopsy displaying > 50% involvement by myeloma)

  • Hemoglobin > 9.0 g/dL

  • Serum SGOT/AST <3.0 x upper limits of normal (ULN)

  • Serum SGPT/ALT <3.0 x upper limits of normal (ULN)

  • Serum creatinine < 2.5 mg/dL or creatinine clearance > 40ml/min

  • Serum total bilirubin < 1.5 x ULN

  • Patients must have a MUGA scan with LVEF >50%

Exclusion criteria

  • Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan.
  • Prior treatment with bortezomib.
  • Peripheral neuropathy of > Grade 2 as defined by CTCAE Version 3.0 (see Appendix II)
  • History of allergic reactions to compounds containing mannitol, bortezomib, conventional formulation of doxorubicin HCL or the components of DOXIL.
  • Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5 years.
  • NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, serious uncontrolled cardiac arrhythmia or myocardial infarction within 6 months.
  • Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Known HIV or hepatitis A, B, or C positivity
  • Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
  • Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, active uncontrolled infection, and/or acute chronic liver disease (i.e., hepatitis, cirrhosis).
  • No prior anti-myeloma therapy within 2 weeks of treatment initiation.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

Treatment Arm
Experimental group
Treatment:
Drug: cyclophoshamide
Drug: dexamethasone
Drug: filgrastim
Drug: liposomal doxorubicin
Drug: Bortezomib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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