Plasma Cell Leukemia in RemissionPhase 1/2NCT03100877
Melphalan, Total Marrow Irradiation, and Autologous Stem Cell Transplantation in Treating Patients With High-Risk Multiple Myeloma
A Phase 1/2 study testing Autologous Hematopoietic Stem Cell Transplantation, Cyclophosphamide and Filgrastim in people with Plasma Cell Leukemia in Remission and Plasma Cell Myeloma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This phase I/II trial studies the side effects and best dose of melphalan and total marrow irradiation and how well they work with autologous stem cell transplantation in treating patients with high-risk multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plasma Cell Leukemia in Remission, Plasma Cell Myeloma
- What is being tested?
- Autologous Hematopoietic Stem Cell Transplantation, Cyclophosphamide and Filgrastim
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2018to 24 May 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with will be eligible if they are either in partial response, or have stable disease after no more than two attempts of induction therapy
- Patients with high-risk cytogenetics, t(4:14); t(14;16), t(14:20), deletion p17, gain in 1q, are eligible
- Patients with plasma cell leukemia in >= partial remission are eligible
- Patients with non-quantifiable monoclonal proteins are eligible provided they meet other criteria for multiple myeloma and they have evaluable or measurable disease by other (radiographic, magnetic resonance imaging [MRI], computed tomography [CT], lytic measurable lesion on x-ray,) means
- Karnofsky performance status (KPS) >= 70%
- Less than 12 months since diagnosis
Show all 17Show fewer
- No contraindication to the collection of a minimum of 4 x 10^6 CD34+ cells/kg by apheresis
- Bilirubin =< 1.5 mg/dl
- Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 x upper limits of normal
- Creatinine of measured or calculated creatinine clearance of >= 50 cc/min
- Absolute neutrophil count of > 1000/ul
- Platelet count of > 100,000/ul
- Cardiac ejection fraction >= 50% by multi-gated acquisition (MUGA) scan and/or by echocardiogram
- Forced expiratory volume in 1 second (FEV1) > 60% and diffusion capacity of the lung for carbon monoxide (DLCO) > 50% of predicted lower limit
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately; patients must be fully aware of the teratogenic potential of immunomodulatory drugs (ImIDs) and agree to fully comply with the mandated guidelines regarding contraception as stated in the informed consent and the patient warning document attached to the consent form; women of childbearing potential must have a negative pregnancy test performed within 24 hours prior to beginning thalidomide, except for woman who have been postmenopausal for at least 2 years, or underwent hysterectomy; use of effective means of contraceptive should be started at least 2 weeks prior to initiating lenalidomide
- All subjects must have the ability to understand and the willingness to sign a written informed consent; they are to give voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- Patients should have finished their prior systemic therapy or radiation therapy, at least 3 weeks before cyclophosphamide or granulocyte colony-stimulating factor (G-CSF)/plerixafor mobilization, and should have finished dexamethasone at least 7 days prior to Plerixafor priming; administration of bisphosphonates needs to be completed at least 2 weeks before cyclophosphamide priming; bisphosphonates can be resumed or started after day 30
Who cannot join
- 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
- Known hypersensitivity to filgrastim or to Escherichia coli (E. coli) derived proteins
- Inability to lie supine in a full body cast for approximately 30 minutes, the anticipated duration of each treatment session
- Previous radiation therapy to more than 20% of bone marrow containing areas, or to any area exceeding 2000 cGy, is an exclusion
- Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
- No other medical, or psychosocial problems, which in the opinion of the primary physician or principal investigator would place the patient at unacceptably high risk from this treatment regimen
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Phase I-II Single Cycle Melphalan/Total Marrow Irradiation (TMI) and Autologous Stem Cell Transplantation (ASCT) Followed by Maintenance in Patients With High-Risk Myeloma and/or Poor Response to Induction Therapy Within 12 Months of Diagnosis
This phase I/II trial studies the side effects and best dose of melphalan and total marrow irradiation and how well they work with autologous stem cell transplantation in treating patients with high-risk multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Total marrow irradiation is a type of radiation therapy and a form of total body irradiation that may deliver focused radiation to the major marrow sites where cancer cells reside. Giving chemotherapy and total-body irradiation before a peripheral autologous blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the safety and determine the maximum tolerated dose (MTD) of melphalan and fractionated total marrow irradiation (TMI) as conditioning regimen for autologous stem cell transplantation (ASCT) in patients with high-risk or treatment-insensitive multiple myeloma (MM). (Phase I) II. Evaluate the safety of the regimen at each dose level by assessing adverse events: type, frequency, severity, attribution, time course, duration.
III. Evaluate the safety of the regimen at each dose level by assessing complication including: infection, delayed engraftment and secondary malignancy.
IV. To assess complete response (CR) and minimal residual disease (MRD) rates at 100 days post ASCT in a phase II expanded cohort of patients treated at the MTD. (Phase II)
SECONDARY OBJECTIVES:
- To assess the predictive value of high risk features inclusive of fluorescent in situ hybridization (FISH), lactate dehydrogenase (LDH), International Staging System (ISS) stage, gene expression profiling (GEP) for CR and minimal residual disease (MRD) for relapse free survival/progression free survival/overall survival (RFS/PFS/OS) after melphalan TMI (mel/TMI).
II. To assess MRD by positron emission tomography (PET), next generation sequencing (NGS), and flow cytometry after mel/TMI, prior to maintenance and correlation with PFS and OS.
III. To assess in a descriptive fashion PFS and OS following mel/TMI and ASCT. IV. Evaluate changes in fludeoxyglucose F-18 (FDG) PET pre and post TMI/melphalan.
TERTIARY OBJECTIVES:
- Assessment of bone marrow residual damage. II. Assessment of immune recovery dynamics. III. To conduct genetic profiling of myeloma cells. IV. Multimodal imaging for non-invasive assessment of treatment effect on bone and marrow.
OUTLINE: This is a phase I, dose-escalation study of melphalan and TMI followed by a phase II study.
MOBILIZATION AND APHERESIS: Patients receive cyclophosphamide intravenously (IV) over 2 hours. Beginning 24 hours after cyclophosphamide administration, patients receive filgrastim subcutaneously (SC) or IV. Patients also undergo apheresis over 4 hours on day 10.
CONDITIONING REGIMEN: Patients receive palifermin IV on days -8, to -6, undergo TMI on days -5 to -2, and receive melphalan IV over 30 minutes on day -1. Patients then undergo ASCT IV on day 0, receive palifermin IV on days 1-3, and receive filgrastim SC or IV on day 5.
MAINTENANCE THERAPY: Beginning 30 days after ASCT, patients receive lenalidomide orally (PO) daily.
- Being tested
- Autologous Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Filgrastim, Laboratory Biomarker Analysis, Lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery
Also called Autologous Stem Cell Transplantation
Undergo ASCT
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida
Given IV
FilgrastimBiological
Also called Filgrastim XM02, Filgrastim-sndz, G-CSF, Neupogen
Given SC or IV
Laboratory Biomarker AnalysisOther
Correlative studies
LenalidomideDrug
Also called CC-5013, CC5013, CDC 501, Revlimid
Given PO
pheresisProcedure or surgery
Also called leukapheresis, Leukocytopheresis, Therapeutic Leukopheresis, apheresis
Undergo apheresis
MelphalanDrug
Also called Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard
Given IV
PaliferminBiological
Also called Growth Factor, Recombinant Human Keratinocyte, Kepivance, Keratinocyte Growth Factor, Recombinant Human, Recombinant Human Keratinocyte Growth Factor
Given IV
Total Marrow IrradiationRadiation
Undergo TMI
| Study group | Role | What they receive |
|---|---|---|
| Treatment (mel/TMI, ASCT) | Experimental | MOBILIZATION AND APHERESIS: Patients receive cyclophosphamide IV over 2 hours. Beginning 24 hours after cyclophosphamide administration, patients receive filgrastim SC or IV. Patients also undergo apheresis over 4 hours on day 10.
CONDITIONING REGIMEN: Patients receive palifermin IV on days -8, to -6, undergo TMI on days -5 to -2, and receive melphalan IV over 30 minutes on day -1. Patients then undergo ASCT IV on day 0, receive palifermin IV on days 1-3, and receive filgrastim SC or IV on day 5.
MAINTENANCE THERAPY: Beginning 30 days after ASCT, patients receive lenalidomide PO daily. Receives: Procedure: Autologous Hematopoietic Stem Cell Transplantation; Drug: Cyclophosphamide; Biological: Filgrastim; Other: Laboratory Biomarker Analysis; Drug: Lenalidomide; Procedure: pheresis; Drug: Melphalan; Biological: Palifermin; Radiation: Total Marrow Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) post-Autologous Stem Cell Transplantation (ASCT) (Phase II)
Will be summarized both by pooling across dose levels and by dose level.
Measured: Up to 3 years
Maximum Tolerated Dose (MTD) of mel/TMI (Phase I)
Toxicity information recorded will include the type, severity, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startJan 2018 (estimated)
- Primary completion24 May 2020 (estimated)
- Study completion24 May 2020 (estimated)
Why it stopped: Feasibility Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell Leukemia in RemissionStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- George Somlo, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100877
- Sponsor's protocol ID
- 16464
- Other IDs
- NCI-2017-00512, 16464
- Status last verified
- Dec 2017
- First submitted
- 29 Mar 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- 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 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Single Cycle Melphalan/Total Marrow Irradiation (TMI) and Autologous Stem Cell Transplantation (ASCT) Followed by Maintenance in Patients With High-Risk Myeloma and/or Poor Response to Induction Therapy Within 12 Months of Diagnosis
- ClinicalTrials.gov ID
- NCT03100877
- Acronym / sponsor ID
- 16464
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility Issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2018 (estimated)
- Primary completion
- 24 May 2020 (estimated)
- Study completion
- 24 May 2020 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies the side effects and best dose of melphalan and total marrow irradiation and how well they work with autologous stem cell transplantation in treating patients with high-risk multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Total marrow irradiation is a type of radiation therapy and a form of total body irradiation that may deliver focused radiation to the major marrow sites where cancer cells reside. Giving chemotherapy and total-body irradiation before a peripheral autologous blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
Detailed description
PRIMARY OBJECTIVES:
- To assess the safety and determine the maximum tolerated dose (MTD) of melphalan and fractionated total marrow irradiation (TMI) as conditioning regimen for autologous stem cell transplantation (ASCT) in patients with high-risk or treatment-insensitive multiple myeloma (MM). (Phase I) II. Evaluate the safety of the regimen at each dose level by assessing adverse events: type, frequency, severity, attribution, time course, duration.
III. Evaluate the safety of the regimen at each dose level by assessing complication including: infection, delayed engraftment and secondary malignancy.
IV. To assess complete response (CR) and minimal residual disease (MRD) rates at 100 days post ASCT in a phase II expanded cohort of patients treated at the MTD. (Phase II)
SECONDARY OBJECTIVES:
- To assess the predictive value of high risk features inclusive of fluorescent in situ hybridization (FISH), lactate dehydrogenase (LDH), International Staging System (ISS) stage, gene expression profiling (GEP) for CR and minimal residual disease (MRD) for relapse free survival/progression free survival/overall survival (RFS/PFS/OS) after melphalan TMI (mel/TMI).
II. To assess MRD by positron emission tomography (PET), next generation sequencing (NGS), and flow cytometry after mel/TMI, prior to maintenance and correlation with PFS and OS.
III. To assess in a descriptive fashion PFS and OS following mel/TMI and ASCT. IV. Evaluate changes in fludeoxyglucose F-18 (FDG) PET pre and post TMI/melphalan.
TERTIARY OBJECTIVES:
- Assessment of bone marrow residual damage. II. Assessment of immune recovery dynamics. III. To conduct genetic profiling of myeloma cells. IV. Multimodal imaging for non-invasive assessment of treatment effect on bone and marrow.
OUTLINE: This is a phase I, dose-escalation study of melphalan and TMI followed by a phase II study.
MOBILIZATION AND APHERESIS: Patients receive cyclophosphamide intravenously (IV) over 2 hours. Beginning 24 hours after cyclophosphamide administration, patients receive filgrastim subcutaneously (SC) or IV. Patients also undergo apheresis over 4 hours on day 10.
CONDITIONING REGIMEN: Patients receive palifermin IV on days -8, to -6, undergo TMI on days -5 to -2, and receive melphalan IV over 30 minutes on day -1. Patients then undergo ASCT IV on day 0, receive palifermin IV on days 1-3, and receive filgrastim SC or IV on day 5.
MAINTENANCE THERAPY: Beginning 30 days after ASCT, patients receive lenalidomide orally (PO) daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (mel/TMI, ASCT) | Experimental | Procedure: Autologous Hematopoietic Stem Cell Transplantation, Drug: Cyclophosphamide, Biological: Filgrastim, Other: Laboratory Biomarker Analysis, Drug: Lenalidomide, Procedure: pheresis, Drug: Melphalan, Biological: Palifermin, Radiation: Total Marrow IrradiationMOBILIZATION AND APHERESIS: Patients receive cyclophosphamide IV over 2 hours. Beginning 24 hours after cyclophosphamide administration, patients receive filgrastim SC or IV. Patients also undergo apheresis over 4 hours on day 10. CONDITIONING REGIMEN: Patients receive palifermin IV on days -8, to -6, undergo TMI on days -5 to -2, and receive melphalan IV over 30 minutes on day -1. Patients then undergo ASCT IV on day 0, receive palifermin IV on days 1-3, and receive filgrastim SC or IV on day 5. MAINTENANCE THERAPY: Beginning 30 days after ASCT, patients receive lenalidomide PO daily. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with will be eligible if they are either in partial response, or have stable disease after no more than two attempts of induction therapy
- Patients with high-risk cytogenetics, t(4:14); t(14;16), t(14:20), deletion p17, gain in 1q, are eligible
- Patients with plasma cell leukemia in >= partial remission are eligible
- Patients with non-quantifiable monoclonal proteins are eligible provided they meet other criteria for multiple myeloma and they have evaluable or measurable disease by other (radiographic, magnetic resonance imaging [MRI], computed tomography [CT], lytic measurable lesion on x-ray,) means
- Karnofsky performance status (KPS) >= 70%
Key exclusion criteria (6 listed)
- 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
- Known hypersensitivity to filgrastim or to Escherichia coli (E. coli) derived proteins
- Inability to lie supine in a full body cast for approximately 30 minutes, the anticipated duration of each treatment session
- Previous radiation therapy to more than 20% of bone marrow containing areas, or to any area exceeding 2000 cGy, is an exclusion
- Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
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 |
|---|---|---|
| Autologous Hematopoietic Stem Cell TransplantationAlso: Autologous Stem Cell TransplantationUndergo ASCT | Procedure or surgery | Treatment (mel/TMI, ASCT) |
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, CiclofosfamidaGiven IV | Drug | Treatment (mel/TMI, ASCT) |
| FilgrastimAlso: Filgrastim XM02, Filgrastim-sndz, G-CSF, NeupogenGiven SC or IV | Biological | Treatment (mel/TMI, ASCT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (mel/TMI, ASCT) |
| LenalidomideAlso: CC-5013, CC5013, CDC 501, RevlimidGiven PO | Drug | Treatment (mel/TMI, ASCT) |
| pheresisAlso: leukapheresis, Leukocytopheresis, Therapeutic Leukopheresis, apheresisUndergo apheresis | Procedure or surgery | Treatment (mel/TMI, ASCT) |
| MelphalanAlso: Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine MustardGiven IV | Drug | Treatment (mel/TMI, ASCT) |
| PaliferminAlso: Growth Factor, Recombinant Human Keratinocyte, Kepivance, Keratinocyte Growth Factor, Recombinant Human, Recombinant Human Keratinocyte Growth FactorGiven IV | Biological | Treatment (mel/TMI, ASCT) |
| Total Marrow IrradiationUndergo TMI | Radiation | Treatment (mel/TMI, ASCT) |
Primary outcome
Complete Response (CR) post-Autologous Stem Cell Transplantation (ASCT) (Phase II)
Time frame: Up to 3 years
Will be summarized both by pooling across dose levels and by dose level.
Maximum Tolerated Dose (MTD) of mel/TMI (Phase I)
Time frame: Up to 3 years
Toxicity information recorded will include the type, severity, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
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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.
George Somlo, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Hematopoietic Stem Cell Transplantation, Cyclophosphamide and Filgrastim in people with Plasma Cell Leukemia in Remission and Plasma Cell Myeloma, run by City of Hope Medical Center 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 6 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: withdrawn, as of the sponsor's last update on 13 Dec 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Complete Response (CR) post-Autologous Stem Cell Transplantation (ASCT) (Phase II) (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 13 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.