Multiple MyelomaPhase 2NCT02703779
Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM)
A Phase 2 study testing Bortezomib, Granulocyte colony-stimulating factor (G-CSF) and Mozobil in people with Multiple Myeloma, run by Siddhartha Ganguly at 1 site in United States.
Trial summary
Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma. 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, Granulocyte colony-stimulating factor (G-CSF) and Mozobil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 8 Apr 2020
- Phase
- Phase 2
- 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
- Subjects must meet all of the inclusion criteria to participate in this study.
- Ability to understand, and the willingness to sign a written Informed Consent Form
- Diagnosis of multiple myeloma undergoing planned autologous stem cell transplantation
- Age ≥ 18 years
- Karnofsky Performance Status (KPS) 70 or above, Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
- Adequate organ and marrow function as defined below:
Show all 17Show fewer
- leukocytes ≥ 3,000/micro Liter (mcL)
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 100,000/mcL
- total bilirubin within normal institutional limits NOTE: For this study, subjects with bilirubin levels > 1.5 Upper Limit of Normal (ULN) are excluded from enrollment in this study.
- Aspartate Aminotransferase (AST) ( Serum Glutamic Oxaloacetic Transaminase [SGOT]) ≤ 2.5 X institutional upper limit of normal
- Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase [SPGT]) ≤ 2.5 X institutional upper limit of normal
- creatinine within normal institutional limits
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.
- A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
Who cannot join
- Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Current or anticipated use of other investigational agents. NOTE the following clarification for this study: Prohibited Concurrent Therapy:
- Participation in clinical trials with other investigational agents that are not included in this trial, within 14 days of the start of this trial until 2 weeks after participant has received the last dose of bortezomib for mobilization.
- Hypersensitivity to bortezomib, boron or mannitol or Granulocyte colony-stimulating factor (G-CSF)
- Subject has received > 6 months of lenalidomide (Revlimid®) therapy prior to stem cell collection
- Subject has known brain metastases. Presence of brain metastases should be excluded from this clinical trial because of poor prognosis and because patients often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Show all 15Show fewer
- Grade 3 or higher peripheral neuropathy
- Bilirubin levels > 1.5 ULN
- Uncontrolled inter-current illness including, but not limited to
- ongoing or active infection
- symptomatic congestive heart failure
- unstable angina pectoris
- cardiac arrhythmia
- psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or nursing: There is a potential for congenital abnormalities and for this regimen to harm nursing infants.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Medical Center
Westwood, Kansas, 66205
About this study
Official title: An Exploratory Trial to Estimate the Proportion of Patients With Tumor Cell Contaminated, Flow Positive Leukapheresis Products Collected With and Without Bortezomib as In-vivo Purging Prior to Autologous Stem Cell Harvest for Multiple Myeloma
Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma.
Read the detailed description
High dose chemotherapy with autologous stem cell transplant has resulted in improved overall survival and is currently considered an effective first line therapy applicable to the majority of patients with multiple myeloma. However disease relapse is inevitable and remains the primary cause of mortality in this cohort.
The purpose of this study is to estimate the proportion of subjects with plasma cell contamination of harvested stem cell product in standard and treatment arms. The study will explore whether or not in-vivo purging of malignant tumor plasma cells will improve progression free survival (PFS) for patients.
The study will consist of two groups:
Group A: Standard of Care (SOC) stem cell collection without in-vivo purging with bortezomib. Granulocyte colony-stimulating factor (G-CSF) and Mozobil used if needed.
Group B: Bortezomib 1.3mg/m^2 will be given subcutaneously (SQ) on days -11 and -8 followed by Granulocyte colony-stimulating factor (G-CSF) on days -4 through -1 prior to stem cell harvest (day 0).
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib, Granulocyte colony-stimulating factor (G-CSF), Mozobil
- Keywords
- Multiple Myeloma, Bortezomib, Autologous, Stem Cell, Purging, In-vivo purging, Ex-vivo purging, Leukapheresis, Contaminated, Stem Cell Harvest, Stem Cell Transplant, Transplantation
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called VELCADE
Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.
Granulocyte colony-stimulating factor (G-CSF)Drug
Also called NEUPOGEN, filgrastim, filgrastim-sndz, Zarxio
Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.
MozobilDrug
Also called plerixafor
Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
| Study group | Role | What they receive |
|---|---|---|
| Stem cell collection without in-vivo purging with Bortezomib | Active comparator | Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).
NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Receives: Drug: Granulocyte colony-stimulating factor (G-CSF); Drug: Mozobil |
| Stem cell collection with in-vivo purging with Bortezomib | Experimental | Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.
There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Receives: Drug: Bortezomib; Drug: Granulocyte colony-stimulating factor (G-CSF); Drug: Mozobil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiparametric Flow Cytometry - Minimum Residual Disease
Estimate the proportion of subjects with plasma cell contamination (defined as >0.01% and at least 100 cellular events) of harvested stem cell product by multi parametric flow cytometry (MFC) from patients with myeloma undergoing autologous stem cell collection 1) by standard of care mobilization using Granulocyte colony-stimulating factor (G-CSF) with or without Mozobil and 2) after two doses of bortezomib as in vivo purging plus standard of care using G-CSF with or without Mozobil.
Measured: Day 0 for all subjects (Day 0 is the day of stem cell collection)
Secondary outcomes (2)
Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment
Estimate the proportion of subjects who have a successful collection of stem cells (> 2 million Cluster of Differentiation 34 (CD34) cells/Kg of body weight) for autologous transplant in both treatment groups.
Measured: Within the first 30 days after stem cell collection
Cluster of Differentiation 34 (CD34) Enumeration
Estimate the percentage of Cluster of Differentiation 34 (CD34) positive cells in circulating peripheral blood as a measure of mobilization on the days of collection.
Measured: Within the first 30 days after stem cell collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion4 Oct 2019
- Study completion8 Apr 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siddhartha Ganguly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Siddhartha Ganguly, University of Kansas Medical Center
- Investigators
- Siddhartha Ganguly, MD, Principal investigator, The University of Kansas - Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703779
- Sponsor's protocol ID
- 2015-IIT-BMT-MM-AutoSCT
- Status last verified
- May 2021
- First submitted
- 18 Feb 2016
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rawstron AC, Orfao A, Beksac M, Bezdickova L, Brooimans RA, Bumbea H, Dalva K, Fuhler G, Gratama J, Hose D, Kovarova L, Lioznov M, Mateo G, Morilla R, Mylin AK, Omede P, Pellat-Deceunynck C, Perez Andres M, Petrucci M, Ruggeri M, Rymkiewicz G, Schmitz A, Schreder M, Seynaeve C, Spacek M, de Tute RM, Van Valckenborgh E, Weston-Bell N, Owen RG, San Miguel JF, Sonneveld P, Johnsen HE; European Myeloma Network. Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders. Haematologica. 2008 Mar;93(3):431-8. doi: 10.3324/haematol.11080. Epub 2008 Feb 11.
PubMed 18268286
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Trial to Estimate the Proportion of Patients With Tumor Cell Contaminated, Flow Positive Leukapheresis Products Collected With and Without Bortezomib as In-vivo Purging Prior to Autologous Stem Cell Harvest for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02703779
- Acronym / sponsor ID
- 2015-IIT-BMT-MM-AutoSCT
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Bortezomib, Autologous, Stem Cell, Purging, In-vivo purging, Ex-vivo purging, Leukapheresis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Siddhartha GangulyUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma.
Detailed description
High dose chemotherapy with autologous stem cell transplant has resulted in improved overall survival and is currently considered an effective first line therapy applicable to the majority of patients with multiple myeloma. However disease relapse is inevitable and remains the primary cause of mortality in this cohort.
The purpose of this study is to estimate the proportion of subjects with plasma cell contamination of harvested stem cell product in standard and treatment arms. The study will explore whether or not in-vivo purging of malignant tumor plasma cells will improve progression free survival (PFS) for patients.
The study will consist of two groups:
Group A: Standard of Care (SOC) stem cell collection without in-vivo purging with bortezomib. Granulocyte colony-stimulating factor (G-CSF) and Mozobil used if needed.
Group B: Bortezomib 1.3mg/m^2 will be given subcutaneously (SQ) on days -11 and -8 followed by Granulocyte colony-stimulating factor (G-CSF) on days -4 through -1 prior to stem cell harvest (day 0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem cell collection without in-vivo purging with Bortezomib | Active comparator | Drug: Granulocyte colony-stimulating factor (G-CSF), Drug: MozobilStandard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B |
| Stem cell collection with in-vivo purging with Bortezomib | Experimental | Drug: Bortezomib, Drug: Granulocyte colony-stimulating factor (G-CSF), Drug: MozobilBortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects must meet all of the inclusion criteria to participate in this study.
- Ability to understand, and the willingness to sign a written Informed Consent Form
- Diagnosis of multiple myeloma undergoing planned autologous stem cell transplantation
- Age ≥ 18 years
- Karnofsky Performance Status (KPS) 70 or above, Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
Key exclusion criteria (15 listed)
- Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Current or anticipated use of other investigational agents. NOTE the following clarification for this study: Prohibited Concurrent Therapy:
- Participation in clinical trials with other investigational agents that are not included in this trial, within 14 days of the start of this trial until 2 weeks after participant has received the last dose of bortezomib for mobilization.
- Hypersensitivity to bortezomib, boron or mannitol or Granulocyte colony-stimulating factor (G-CSF)
- Subject has received > 6 months of lenalidomide (Revlimid®) therapy prior to stem cell collection
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 |
|---|---|---|
| BortezomibAlso: VELCADEBortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. | Drug | Stem cell collection with in-vivo purging with Bortezomib |
| Granulocyte colony-stimulating factor (G-CSF)Also: NEUPOGEN, filgrastim, filgrastim-sndz, ZarxioGranulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. | Drug | Stem cell collection with in-vivo purging with Bortezomib, Stem cell collection without in-vivo purging with Bortezomib |
| MozobilAlso: plerixaforMozobil will be given to all participants by injection under the skin only if needed per Investigator. | Drug | Stem cell collection with in-vivo purging with Bortezomib, Stem cell collection without in-vivo purging with Bortezomib |
Primary outcome
Multiparametric Flow Cytometry - Minimum Residual Disease
Time frame: Day 0 for all subjects (Day 0 is the day of stem cell collection)
Estimate the proportion of subjects with plasma cell contamination (defined as >0.01% and at least 100 cellular events) of harvested stem cell product by multi parametric flow cytometry (MFC) from patients with myeloma undergoing autologous stem cell collection 1) by standard of care mobilization using Granulocyte colony-stimulating factor (G-CSF) with or without Mozobil and 2) after two doses of bortezomib as in vivo purging plus standard of care using G-CSF with or without Mozobil.
2 secondary outcomes
Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment
Time frame: Within the first 30 days after stem cell collection
Cluster of Differentiation 34 (CD34) Enumeration
Time frame: Within the first 30 days after stem cell collection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18268286Rawstron AC, Orfao A, Beksac M, Bezdickova L, Brooimans RA, Bumbea H, Dalva K, Fuhler G, Gratama J, Hose D, Kovarova L, Lioznov M, Mateo G, Morilla R, Mylin AK, Omede P, Pellat-Deceunynck C, Perez Andres M, Petrucci M, Ruggeri M, Rymkiewicz G, Schmitz A, Schreder M, Seynaeve C, Spacek M, de Tute RM, Van Valckenborgh E, Weston-Bell N, Owen RG, San Miguel JF, Sonneveld P, Johnsen HE; European Myeloma Network. Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders. Haematologica. 2008 Mar;93(3):431-8. doi: 10.3324/haematol.11080. Epub 2008 Feb 11.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Siddhartha Ganguly, MD principal investigator
The University of Kansas - Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib, Granulocyte colony-stimulating factor (G-CSF) and Mozobil in people with Multiple Myeloma, run by Siddhartha Ganguly at 1 site 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 15 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 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 18 Jun 2021). 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?
Multiparametric Flow Cytometry - Minimum Residual Disease (time frame: Day 0 for all subjects (Day 0 is the day of stem cell collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02703779, which also lists 1 linked publication.
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 18 Jun 2021.