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A Prospective Randomized Trial Comparing Three Different Peripheral Stem Cell Mobilization Regimens in Patients With Symptomatic Multiple Myeloma

Phase 3
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

A Prospective Randomized Trial Comparing Three Different Peripheral Stem Cell Mobilization Regimens in Patients With Symptomatic Multiple Myeloma


• 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


• 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

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.

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Description:

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).

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Ruben Niesvizky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Institutional Review Board

Study ID:




Start Date:

March 2011

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Weill Cornell Medical CollegeNew York, New York  10021