Multiple MyelomaPhase 3NCT01146834
Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma
A Phase 3 study testing bortezomib (Velcade), cyclophosphamide and G-CSF in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- bortezomib (Velcade), cyclophosphamide and G-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2011to 4 Feb 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
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- 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 <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
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University
Atlanta, Georgia, 30322
New York University Cancer Institute
New York, New York, 10016
Columbia Presbyterian Medical Center):
New York, New York, 10032
Memorial Sloan-Kettering Cancer Center):
New York, New York, 10065
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: A Prospective Randomized Trial Comparing Three Different Peripheral Stem Cell Mobilization Regimens in Patients With Symptomatic Multiple Myeloma or Lymphoma
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
Read the 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
- Percentage of patients able to collect >6 x 106 CD34+ cells/kg in < 2 collections.
Secondary Endpoints
- Engrafting: Neutrophil recovery (ANC >0.5 of <12 days), Plt recovery (>20K untransfused <20 days)) after mel 200 based transplant.
- Toxicities
- Conditions
- Multiple Myeloma
- Being tested
- bortezomib (Velcade), cyclophosphamide, G-CSF, Plerixafor
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomib (Velcade)Drug
Also called Velcade
1.3 mg/m2 IVP on days 1, 4, 8 and 11
cyclophosphamideDrug
Also called Cytoxan
2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSFDrug
Also called Filgrastim, Neupogen
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 and start on Day 1 for Arm D)
PlerixaforDrug
Also called Mozobil
plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF | Experimental | 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. Receives: Drug: bortezomib (Velcade); Drug: cyclophosphamide; Drug: G-CSF |
| Arm B: VELCADE & G-CSF | Experimental | 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 Receives: Drug: bortezomib (Velcade); Drug: G-CSF |
| Arm C: CYCLOPHOSPHAMIDE & G-CSF | Experimental | 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. Receives: Drug: cyclophosphamide; Drug: G-CSF |
| Arm D: PLERIXAFOR & G-CSF | Experimental | G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status. Receives: Drug: G-CSF; Drug: Plerixafor |
| Arm E: PLERIXAFOR, VELCADE, & G-CSF | Experimental | Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.
Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status. Receives: Drug: bortezomib (Velcade); Drug: G-CSF; Drug: Plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.
The primary endpoint in all five 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). Note that no patients were enrolled Arm D and Arm E.
Measured: 36 months
Secondary outcomes (2)
Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant
Number of patients who achieved neutrophil recovery after Melphalan 200 based transplant in 20 days or fewer. Neutrophil recovery is defined as an absolute neutrophil count of greater than 0.5 k/uL for three consecutive days.
Measured: 20 days post-transplant
Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant
Number of patients who achieved platelet recovery after Melphalan 200 based transplant in 20 days or fewer. Platelet recovery is defined as a platelet count of greater than 20,000, untransfused, for three consecutive days.
Measured: 20 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMar 2011
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Ruben Niesvizky, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146834
- Sponsor's protocol ID
- 1005011049
- Other IDs
- X05324
- Status last verified
- Dec 2019
- First submitted
- 16 Jun 2010
- Last updated
- 27 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Three Different Peripheral Stem Cell Mobilization Regimens in Patients With Symptomatic Multiple Myeloma or Lymphoma
- ClinicalTrials.gov ID
- NCT01146834
- Acronym / sponsor ID
- 1005011049
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Mar 2011 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 17 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Percentage of patients able to collect >6 x 106 CD34+ cells/kg in < 2 collections.
Secondary Endpoints
- Engrafting: Neutrophil recovery (ANC >0.5 of <12 days), Plt recovery (>20K untransfused <20 days)) after mel 200 based transplant.
- Toxicities
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF | Experimental | Drug: bortezomib (Velcade), Drug: cyclophosphamide, Drug: G-CSFVELCADE 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. |
| Arm B: VELCADE & G-CSF | Experimental | Drug: bortezomib (Velcade), Drug: G-CSFVELCADE 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 |
| Arm C: CYCLOPHOSPHAMIDE & G-CSF | Experimental | Drug: cyclophosphamide, Drug: G-CSFHigh-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. |
| Arm D: PLERIXAFOR & G-CSF | Experimental | Drug: G-CSF, Drug: PlerixaforG-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status. |
| Arm E: PLERIXAFOR, VELCADE, & G-CSF | Experimental | Drug: bortezomib (Velcade), Drug: G-CSF, Drug: PlerixaforBortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomib (Velcade)Also: Velcade1.3 mg/m2 IVP on days 1, 4, 8 and 11 | Drug | Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF, Arm B: VELCADE & G-CSF, Arm E: PLERIXAFOR, VELCADE, & G-CSF |
| cyclophosphamideAlso: Cytoxan2.0 g/m2 (day 4 for Arm A and day 1 for Arm C) | Drug | Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF, Arm C: CYCLOPHOSPHAMIDE & G-CSF |
| G-CSFAlso: Filgrastim, Neupogengiven for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) | Drug | 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 |
| PlerixaforAlso: Mozobilplerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E) | Drug | Arm D: PLERIXAFOR & G-CSF, Arm E: PLERIXAFOR, VELCADE, & G-CSF |
Primary outcome
Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.
Time frame: 36 months
The primary endpoint in all five 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). Note that no patients were enrolled Arm D and Arm E.
2 secondary outcomes
Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant
Time frame: 20 days post-transplant
Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant
Time frame: 20 days post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Niesvizky, MD principal investigator
Weill Medical College of Cornell University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bortezomib (Velcade), cyclophosphamide and G-CSF in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019.