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Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01146834
First received: June 16, 2010
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

This phase III randomized trial compares three different peripheral stem cell mobilization regimens for patients with multiple myeloma who have received primary induction therapy or other therapies. Up to 180 patients will be enrolled. Patients eligible for treatment will be randomized to one of the three following mobilization regimens:

Arm A = VELCADE, CYCLOPHOSPHAMIDE, G-CSF Arm B = VELCADE & G-CSF Arm C = CYCLOPHOSPHAMIDE & G-CSF


Condition Intervention Phase
Multiple Myeloma
Drug: bortezomib (Velcade)
Drug: cyclophosphamide
Drug: G-CSF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Comparing Three Different Peripheral Stem Cell Mobilization Regimens in Patients With Symptomatic Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Percentage of patients able to collect >6 x 106 CD34+ cells/kg in < 2 collections. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    The primary endpoint in all three treatment arms is the percentage of patients who are able to achieve greater than 6 x 106 CD34+ stems cells/kg harvested (defined as effectiveness).


Estimated Enrollment: 180
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
Drug: bortezomib (Velcade)
1.3 mg/m2 IVP on days 1, 4, 8 and 11
Other Name: Velcade
Drug: cyclophosphamide
2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
Other Name: Cytoxan
Drug: G-CSF
given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C)
Other Names:
  • Filgrastim
  • Neupogen
Experimental: Arm B
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
Drug: bortezomib (Velcade)
1.3 mg/m2 IVP on days 1, 4, 8 and 11
Other Name: Velcade
Drug: G-CSF
given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C)
Other Names:
  • Filgrastim
  • Neupogen
Experimental: Arm C
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
Drug: cyclophosphamide
2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
Other Name: Cytoxan
Drug: G-CSF
given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C)
Other Names:
  • Filgrastim
  • Neupogen

Detailed Description:

PRIMARY STUDY OBJECTIVES

• To compare the efficacy of the following peripheral stem cell mobilization regimens for MM: i. High dose cyclophosphamide, VELCADE, and G-CSF ii. VELCADE and G-CSF iii. High dose cyclophosphamide and G-CSF

SECONDARY STUDY OBJECTIVES

• To evaluate biomarkers as surrogate markers of mobilization in each arm To evaluate changes in tumor mass as defined by standard response parameters. To evaluate the safety of each of the arms.

This phase III randomized trial compares three different peripheral stem cell mobilization regimens for patients with multiple myeloma who have received primary induction therapy

Primary Endpoints

a) Percentage of patients able to collect >6 x 106 CD34+ cells/kg in < 2 collections.

Secondary Endpoints

  1. Engrafting: Neutrophil recovery (ANC >0.5 of <12 days), Plt recovery (>20K untransfused <20 days)) after mel 200 based transplant.
  2. Toxicities
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntary written informed consent
  • Confirmed diagnosis of multiple myeloma
  • Age > than 18 years at the time of signing the informed consent form.
  • Karnofsky performance status > = 70%
  • Patients must be within 30 days of completing induction therapy.
  • Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control .
  • Male subject agrees to use an acceptable method for contraception for the duration of the study.
  • Life expectancy > 12 weeks.
  • Subjects must have a MUGA scan or echo with LVEF >50%
  • Subjects must meet the following laboratory parameters:

    1. Absolute neutrophil count (ANC) ≥1500 cells/mm3
    2. Platelets count ≥ 50,000/mm3
    3. Hemoglobin > 9.0 g/dL
    4. Serum SGOT/AST <3.0 x upper limits of normal (ULN)
    5. Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
    6. Serum creatinine < 2.5 mg/dL or creatinine clearance > 40ml/min
    7. Serum total bilirubin < 1.5 x ULN

Exclusion Criteria:

  • Patients with (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.
  • History of allergic reactions to compounds containing boron, mannitol, VELCADE
  • 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 > = 5 years.
  • NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, severe uncontrolled cardiac arrhythmia, electrocardiographic evidence of acute ischemia, active conduction system abnormalities or myocardial infarction within 6 months prior to enrollment. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  • 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---ONLY IF ACTIVE
  • 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
  • Patient has > = Grade 2 peripheral neuropathy within 14 days before enrollment.
  • Patient has received other investigational drugs with 14 days before enrollment
  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146834

Contacts
Contact: Ruben Niesvizky, MD 646-962-2070 run9001@med.cornell.edu
Contact: Manan Shah 212-746-5970 mas2146@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Ruben Niesvizky, MD    646-962-2070    run9001@med.cornell.edu   
Principal Investigator: Ruben Niesvizky, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Ruben Niesvizky, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Dr. Ruben Niesvizky, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT01146834     History of Changes
Other Study ID Numbers: 1005011049, X05324
Study First Received: June 16, 2010
Last Updated: March 24, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bortezomib
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014