Phase 3
N=47
Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01146834 ↗Enrolled (actual)
47
Serious AEs
2.1%
Results posted
Dec 2019
Primary outcome: Primary: Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections. — 11; 0; 14 Participants — p=0.90
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- bortezomib (Velcade) (Drug); cyclophosphamide (Drug); G-CSF (Drug); Plerixafor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections. |
11; 0; 14 | 0.90 |
| SECONDARY Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant |
7; 4; 11; 0; 0 | — |
| SECONDARY Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant |
4; 1; 9; 0; 0 | 0.25 |
Summary
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 Arm D = PLERIXAFOR & G-CSF Arm E = PLERIXAFOR, VELCADE, & G-CSF
Eligibility 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 above 60%
- 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:
- Absolute neutrophil count (ANC) ≥1500 cells/mm3
- Platelets count ≥ 50,000/mm3
- Hemoglobin > 9.0 g/dL
- Serum SGOT/AST 40ml/min
- Serum total bilirubin = 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.
Data sourced from ClinicalTrials.gov (NCT01146834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.