MyelomaPhase 2NCT02114502
Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma
A Phase 2 study testing Carfilzomib, SAHA and Gemcitabine in people with Myeloma, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if carfilzomib and vorinostat combined with gemcitabine, busulfan, and melphalan with a stem cell transplant will help to control multiple myeloma (MM). Researchers also want to learn about the safety and effectiveness of this combination. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myeloma
- What is being tested?
- Carfilzomib, SAHA and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2018
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Refractory or relapsed myeloma, defined as one or more of the following: 1. Patients with myeloma treated with first-line therapy including lenalidomide, bortezomib or thalidomide, and one or more of the following: a. Less than partial response to first-line therapy. b. Relapse after 1st line therapy. 2. High-risk disease, defined by del(13q) by conventional cytogenetics, or by del(17p), t(4;14), t(14;16), t(14;20) or 1q+ by FISH. 3. Relapse after a prior autologous stem-cell transplantation (ASCT). 4. Plasma cell leukemia. 5. Plasmablastic lymphoma. 6. Soft tissue plasmacytoma.
- Adequate renal function, as defined by serum creatinine </=1.8 mg/dL and/or estimated serum creatinine clearance >/=50 ml/min.
- Adequate hepatic function, as defined by serum glutamate oxaloacetate (SGOT) and/or serum glutamic-pyruvic transaminase (SGPT) </=3 x upper limit of normal; serum bilirubin and alkaline phosphatase </=2 x upper limit of normal, unless proven to be due to disease involvement.
- Adequate pulmonary function with FEV1, FVC and DLCO >/=50% of expected corrected for hemoglobin and/or volume.
- Adequate cardiac function with left ventricular ejection fraction >/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance status <2.
- Negative Beta HCG text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
Who cannot join
- Patients with grade >/= 3 non-hematologic toxicity from previous therapy that has not resolved to </= grade 1.
- Prior whole brain irradiation.
- Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000 copies/mL, or >/= 2,000 IU/mL).
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- Active infection requiring parenteral antibiotics.
- HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts.
- Patients having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment.
- Autologous stem-cell transplant in the previous six months.
About this study
Official title: Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Myeloma
The goal of this clinical research study is to learn if carfilzomib and vorinostat combined with gemcitabine, busulfan, and melphalan with a stem cell transplant will help to control multiple myeloma (MM). Researchers also want to learn about the safety and effectiveness of this combination.
Read the detailed description
Busulfan Test Dose:
Participant will receive a test dose of busulfan by vein over about 60 minutes. This low-level test dose of busulfan is to check how the level of busulfan in participant's blood changes over time. This information will be used to decide the next dose needed to reach the target blood level that matches participant's body size. Participant will most likely receive this as an outpatient during the week before they are admitted to the hospital. If it cannot be given to participant as an outpatient, they will be admitted to the hospital on Day -11 (11 days before participant's stem cells are returned to their body) and the test dose will be given on Day -10.
About 11 samples of blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing of busulfan. PK testing measures the amount of study drug in the body at different time points and will help the study doctor decide what participant's dose of busulfan in this study should be. These blood samples will be drawn at various timepoints before participant receives busulfan and over about the next 11 hours. The blood samples will be repeated again on the first day of high-dose busulfan treatment (Day -8). A temporary heparin lock line will be placed in participant's vein to lower the number of needle sticks needed for these draws. If it is not possible for the PK tests to be performed for technical or scheduling reasons, participant will receive the standard fixed dose of busulfan.
If participant receives the busulfan test dose as an outpatient:
On Days -12, -11, and -10, participant will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.
Participant will be admitted to the hospital on Day -9.
If participant receives the busulfan test dose as an inpatient:
On Days -14, -13, and -12, participant will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.
Participant will be admitted to the hospital on Day -11.
Study Drug Administration (for all participants):
With stem cell transplants, the days before participant receives their stem cells are called minus days. The day participant receives the stem cells is called Day 0. The days after participant receives their stem cells are called plus days.
Beginning on Day -9, participant will swish the liquids caphosol and glutamine in their mouth 4 times a day, for about 2 minutes each time. Participant will swish these liquids every day until they leave the hospital. These drugs are used to help decrease the risk of side effects in the mouth and throat.
On Day -9 through Day -2, participant will receive dexamethasone 2 times a day by vein over about 10 minutes.
On Day -8 through Day -2, participant will take vorinostat by mouth, with food.
On Day -8, participant will receive gemcitabine by vein over about 4 hours.
On Days -8, -7, -6, and -5, participant will receive busulfan by vein over about 3 hours.
On Days -7 and -6, participant will receive carfilzomib by vein over about 2-10 minutes.
On Day -3, participant will receive gemcitabine by vein over about 4 hours and melphalan by vein over 30 minutes.
On Day -2, participant will receive carfilzomib by vein over about 2-10 minutes and melphalan by vein over about 30 minutes.
On Day -1, participant will receive carfilzomib by vein over about 2-10 minutes.
On Day 0, participant will receive their stem cells by vein over about 30-60 minutes.
Participant will receive 3 more doses of palifermin by vein over about 15-30 seconds on Days 0, +1 and +2.
As part of standard care, participant will receive G-CSF (filgrastim) as an injection just under their skin 1 time a day starting on Day +5 until their blood cell levels return to normal.
Study Tests:
About 1 month, 100 days, 6 months, 1 year, and then about every 3-6 months for at least 2 years after the transplant:
- Participant will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests, to learn how the transplant has taken, and to check the status of the disease.
About 100 days after the transplant, participant will have a bone marrow biopsy and aspiration to check the status of the disease. To collect a bone marrow biopsy and aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone and bone marrow is withdrawn through a large needle. This will be repeated once a year or earlier, if participant's doctor thinks it is needed.
Once a year, participant will have x-rays of all the bones in their body to check the status of the disease.
The study staff will also stay in contact with participant's local doctor to find out if the disease comes back and to check how they are doing.
Length of Treatment:
As part of standard care, participant will remain in the hospital for about 3-4 weeks after the transplant. After participant is released from the hospital, they will continue as an outpatient in the Houston area to be monitored for infections and transplant-related complications.
Participant will be taken off study about 2 years after the transplant. Participant may be taken off study early if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
If for any reason participant wants to leave the study early, they must talk to the study doctor. It may be life-threatening to leave the study after participant has started to receive the study drugs but before they receive the stem cell transplant because their blood cell counts will be dangerously low.
This is an investigational study. Carfilzomib and melphalan are FDA approved for the treatment of MM. Vorinostat is FDA approved for the treatment of cutaneous lymphoma. Busulfan is FDA approved for the treatment of leukemia. Gemcitabine is FDA approved for the treatment of lymphoma, breast cancer, and lung cancer. The use of these study drugs in combination is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 75 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Myeloma
- Being tested
- Carfilzomib, SAHA, Gemcitabine, Busulfan, Melphalan
- Keywords
- Myeloma, Multiple myeloma, MM, Refractory, Relapsed, Stem Cell Transplant, SCT, Carfilzomib, SAHA, Vorinostat, Suberoylanilide Hydroxamic Acid, MSK-390, Zolinza, Gemcitabine, Gemcitabine Hydrochloride, Gemzar, Busulfan, Busulfex, Myleran, Palifermin
- Medical subject headings
- Neoplasms, Plasma Cell, Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarfilzomibDrug
27 mg/m2 by vein on Days -7 and -6, then on Days -2 and -1
SAHADrug
Also called Vorinostat, Suberoylanilide Hydroxamic Acid, MSK-390, Zolinza
1,000 mg by mouth on Days -8 to -3.
GemcitabineDrug
Also called Gemcitabine Hydrochloride, Gemzar
Loading dose of 75 mg/m2 followed by continuous infusion of the remaining dose of 1875 mg/m2 by vein on Days -8 and -3.
BusulfanDrug
Also called Busulfex, Myleran
Test dose of 32 mg/m2 by vein on Day -10 if inpatient, on Day -12 if outpatient, then AUC of 4,000 microMol.min on Days -8 to -5.
MelphalanDrug
Also called Alkeran
60 mg/m2 by vein on Days -3 and -2.
Stem Cell Transplant (SCT)Procedure or surgery
Stem cell transplant on Day 0.
PaliferminDrug
Also called Kepivance
60 microgram/kg by vein on Days -12 to -10 and Days 0, +1 and +2.
DexamethasoneDrug
Also called Decadron
8 mg by vein twice a day from Day -9 PM to Day -2 PM.
CaphosolDrug
30 mL oral rinse four times a day from Day -9 until discharge.
GlutamineDrug
Also called Enterex, Glutapak-10, NutreStore, Resource
15 g four times a day, swished, gargled and spit on Day -9 until discharge.
PyridoxineDrug
100 mg by vein or mouth three times a day from Day -1.
| Study group | Role | What they receive |
|---|---|---|
| Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT | Experimental | Busulfan test dose of 32 mg/m2 by vein on Day -10 if inpatient, on Day -12 if outpatient, then AUC of 4,000 microMol.min on Days -8 to -5. Palifermin 60 microgram/kg by vein on Days -12 to -10 and Days 0, +1 and +2. SAHA 1,000 mg by mouth on Days -8 to -3. Gemcitabine loading dose of 75 mg/m2 followed by continuous infusion of the remaining dose of 1875 mg/m2 by vein on Days -8 and -3. Carfilzomib 27 mg/m2 by vein on Days -7 and -6, then on Days -2 and -1. SAHA 1,000 mg by mouth on Days -7 to -3. Melphalan 60 mg/m2 by vein on Days -3 and -2. Stem cell transplant on Day 0. Dexamethasone 8 mg by vein twice a day from Day -9 PM to Day -2 PM. Caphosol oral rinses 30 mL four times a day from Day -9 until discharge. Oral glutamine 15 g four times a day, swished, gargled and spit on Day -9 until discharge. Pyridoxine 100 mg by vein or mouth three times a day from Day -1. Receives: Drug: Carfilzomib; Drug: SAHA; Drug: Gemcitabine; Drug: Busulfan; Drug: Melphalan; Procedure: Stem Cell Transplant (SCT); Drug: Palifermin; Drug: Dexamethasone; Drug: Caphosol; Drug: Glutamine; Drug: Pyridoxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission (CR) Rate
Complete remission (CR) rate defined as percentage of number of complete responses in total number of patients treated.
Measured: 100 days
Secondary outcomes (1)
Response Rates (RR)
Response rates (CR; CR/VGPR; RR) reported along with corresponding 95% confidence intervals. Logistic regression used to model the association between response rates and prognostic factors. Overall survival (OS) and progression free survival (PFS) estimated by the Kaplan-Meier method. Comparison of time to event endpoints by subgroups made using the log-rank test. Cox proportional hazards regression employed for univariate and multivariate analysis on time-to-event outcomes.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yago Nieto, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114502
- Sponsor's protocol ID
- 2013-0892
- Status last verified
- Jul 2014
- First submitted
- 11 Apr 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Myeloma
- ClinicalTrials.gov ID
- NCT02114502
- Acronym / sponsor ID
- 2013-0892
- Conditions
- Myeloma
- Keywords
- Myeloma, Multiple myeloma, MM, Refractory, Relapsed, Stem Cell Transplant, SCT, Carfilzomib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2018 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- 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.
The goal of this clinical research study is to learn if carfilzomib and vorinostat combined with gemcitabine, busulfan, and melphalan with a stem cell transplant will help to control multiple myeloma (MM). Researchers also want to learn about the safety and effectiveness of this combination.
Detailed description
Busulfan Test Dose:
Participant will receive a test dose of busulfan by vein over about 60 minutes. This low-level test dose of busulfan is to check how the level of busulfan in participant's blood changes over time. This information will be used to decide the next dose needed to reach the target blood level that matches participant's body size. Participant will most likely receive this as an outpatient during the week before they are admitted to the hospital. If it cannot be given to participant as an outpatient, they will be admitted to the hospital on Day -11 (11 days before participant's stem cells are returned to their body) and the test dose will be given on Day -10.
About 11 samples of blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing of busulfan. PK testing measures the amount of study drug in the body at different time points and will help the study doctor decide what participant's dose of busulfan in this study should be. These blood samples will be drawn at various timepoints before participant receives busulfan and over about the next 11 hours. The blood samples will be repeated again on the first day of high-dose busulfan treatment (Day -8). A temporary heparin lock line will be placed in participant's vein to lower the number of needle sticks needed for these draws. If it is not possible for the PK tests to be performed for technical or scheduling reasons, participant will receive the standard fixed dose of busulfan.
If participant receives the busulfan test dose as an outpatient:
On Days -12, -11, and -10, participant will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.
Participant will be admitted to the hospital on Day -9.
If participant receives the busulfan test dose as an inpatient:
On Days -14, -13, and -12, participant will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.
Participant will be admitted to the hospital on Day -11.
Study Drug Administration (for all participants):
With stem cell transplants, the days before participant receives their stem cells are called minus days. The day participant receives the stem cells is called Day 0. The days after participant receives their stem cells are called plus days.
Beginning on Day -9, participant will swish the liquids caphosol and glutamine in their mouth 4 times a day, for about 2 minutes each time. Participant will swish these liquids every day until they leave the hospital. These drugs are used to help decrease the risk of side effects in the mouth and throat.
On Day -9 through Day -2, participant will receive dexamethasone 2 times a day by vein over about 10 minutes.
On Day -8 through Day -2, participant will take vorinostat by mouth, with food.
On Day -8, participant will receive gemcitabine by vein over about 4 hours.
On Days -8, -7, -6, and -5, participant will receive busulfan by vein over about 3 hours.
On Days -7 and -6, participant will receive carfilzomib by vein over about 2-10 minutes.
On Day -3, participant will receive gemcitabine by vein over about 4 hours and melphalan by vein over 30 minutes.
On Day -2, participant will receive carfilzomib by vein over about 2-10 minutes and melphalan by vein over about 30 minutes.
On Day -1, participant will receive carfilzomib by vein over about 2-10 minutes.
On Day 0, participant will receive their stem cells by vein over about 30-60 minutes.
Participant will receive 3 more doses of palifermin by vein over about 15-30 seconds on Days 0, +1 and +2.
As part of standard care, participant will receive G-CSF (filgrastim) as an injection just under their skin 1 time a day starting on Day +5 until their blood cell levels return to normal.
Study Tests:
About 1 month, 100 days, 6 months, 1 year, and then about every 3-6 months for at least 2 years after the transplant:
- Participant will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests, to learn how the transplant has taken, and to check the status of the disease.
About 100 days after the transplant, participant will have a bone marrow biopsy and aspiration to check the status of the disease. To collect a bone marrow biopsy and aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone and bone marrow is withdrawn through a large needle. This will be repeated once a year or earlier, if participant's doctor thinks it is needed.
Once a year, participant will have x-rays of all the bones in their body to check the status of the disease.
The study staff will also stay in contact with participant's local doctor to find out if the disease comes back and to check how they are doing.
Length of Treatment:
As part of standard care, participant will remain in the hospital for about 3-4 weeks after the transplant. After participant is released from the hospital, they will continue as an outpatient in the Houston area to be monitored for infections and transplant-related complications.
Participant will be taken off study about 2 years after the transplant. Participant may be taken off study early if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
If for any reason participant wants to leave the study early, they must talk to the study doctor. It may be life-threatening to leave the study after participant has started to receive the study drugs but before they receive the stem cell transplant because their blood cell counts will be dangerously low.
This is an investigational study. Carfilzomib and melphalan are FDA approved for the treatment of MM. Vorinostat is FDA approved for the treatment of cutaneous lymphoma. Busulfan is FDA approved for the treatment of leukemia. Gemcitabine is FDA approved for the treatment of lymphoma, breast cancer, and lung cancer. The use of these study drugs in combination is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 75 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT | Experimental | Drug: Carfilzomib, Drug: SAHA, Drug: Gemcitabine, Drug: Busulfan, Drug: Melphalan, Procedure: Stem Cell Transplant (SCT), Drug: Palifermin, Drug: Dexamethasone, Drug: Caphosol, Drug: Glutamine, Drug: PyridoxineBusulfan test dose of 32 mg/m2 by vein on Day -10 if inpatient, on Day -12 if outpatient, then AUC of 4,000 microMol.min on Days -8 to -5. Palifermin 60 microgram/kg by vein on Days -12 to -10 and Days 0, +1 and +2. SAHA 1,000 mg by mouth on Days -8 to -3. Gemcitabine loading dose of 75 mg/m2 followed by continuous infusion of the remaining dose of 1875 mg/m2 by vein on Days -8 and -3. Carfilzomib 27 mg/m2 by vein on Days -7 and -6, then on Days -2 and -1. SAHA 1,000 mg by mouth on Days -7 to -3. Melphalan 60 mg/m2 by vein on Days -3 and -2. Stem cell transplant on Day 0. Dexamethasone 8 mg by vein twice a day from Day -9 PM to Day -2 PM. Caphosol oral rinses 30 mL four times a day from Day -9 until discharge. Oral glutamine 15 g four times a day, swished, gargled and spit on Day -9 until discharge. Pyridoxine 100 mg by vein or mouth three times a day from Day -1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 65 years
- Refractory or relapsed myeloma, defined as one or more of the following: 1. Patients with myeloma treated with first-line therapy including lenalidomide, bortezomib or thalidomide, and one or more of the following: a. Less than partial response to first-line therapy. b. Relapse after 1st line therapy. 2. High-risk disease, defined by del(13q) by conventional cytogenetics, or by del(17p), t(4;14), t(14;16), t(14;20) or 1q+ by FISH. 3. Relapse after a prior autologous stem-cell transplantation (ASCT). 4. Plasma cell leukemia. 5. Plasmablastic lymphoma. 6. Soft tissue plasmacytoma.
- Adequate renal function, as defined by serum creatinine </=1.8 mg/dL and/or estimated serum creatinine clearance >/=50 ml/min.
- Adequate hepatic function, as defined by serum glutamate oxaloacetate (SGOT) and/or serum glutamic-pyruvic transaminase (SGPT) </=3 x upper limit of normal; serum bilirubin and alkaline phosphatase </=2 x upper limit of normal, unless proven to be due to disease involvement.
- Adequate pulmonary function with FEV1, FVC and DLCO >/=50% of expected corrected for hemoglobin and/or volume.
Key exclusion criteria (8 listed)
- Patients with grade >/= 3 non-hematologic toxicity from previous therapy that has not resolved to </= grade 1.
- Prior whole brain irradiation.
- Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000 copies/mL, or >/= 2,000 IU/mL).
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- Active infection requiring parenteral antibiotics.
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 |
|---|---|---|
| Carfilzomib27 mg/m2 by vein on Days -7 and -6, then on Days -2 and -1 | Drug | Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT |
| SAHAAlso: Vorinostat, Suberoylanilide Hydroxamic Acid, MSK-390, Zolinza1,000 mg by mouth on Days -8 to -3. | Drug | Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT |
| GemcitabineAlso: Gemcitabine Hydrochloride, GemzarLoading dose of 75 mg/m2 followed by continuous infusion of the remaining dose of 1875 mg/m2 by vein on Days -8 and -3. | Drug | Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT |
| BusulfanAlso: Busulfex, MyleranTest dose of 32 mg/m2 by vein on Day -10 if inpatient, on Day -12 if outpatient, then AUC of 4,000 microMol.min on Days -8 to -5. | Drug | Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT |
| MelphalanAlso: Alkeran60 mg/m2 by vein on Days -3 and -2. | Drug | Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT |
| Stem Cell Transplant (SCT)Stem cell transplant on Day 0. | Procedure or surgery | Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT |
| PaliferminAlso: Kepivance60 microgram/kg by vein on Days -12 to -10 and Days 0, +1 and +2. | Drug | Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT |
| DexamethasoneAlso: Decadron8 mg by vein twice a day from Day -9 PM to Day -2 PM. | Drug | Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT |
| Caphosol30 mL oral rinse four times a day from Day -9 until discharge. | Drug | Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT |
| GlutamineAlso: Enterex, Glutapak-10, NutreStore, Resource15 g four times a day, swished, gargled and spit on Day -9 until discharge. | Drug | Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT |
| Pyridoxine100 mg by vein or mouth three times a day from Day -1. | Drug | Carfilzomib/SAHA + Gem/Bu/Mel + Auto Stem Cell Transplant SCT |
Primary outcome
Complete Remission (CR) Rate
Time frame: 100 days
Complete remission (CR) rate defined as percentage of number of complete responses in total number of patients treated.
1 secondary outcome
Response Rates (RR)
Time frame: 100 days
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 11 Jul 2014.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Yago Nieto, MD,PHD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carfilzomib, SAHA and Gemcitabine in people with Myeloma, run by M.D. Anderson Cancer Center.
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 8 inclusion and 8 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 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Remission (CR) Rate (time frame: 100 days). 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 11 Jul 2014.