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: Patients post first line therapy 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:

  • For patients post induction therapy, any measurable paraprotein in the serum or urine and/or any plasmacytoma present on physical exam or imaging.
  • 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: liposomal doxorubicin
Drug: filgrastim
Drug: Bortezomib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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