Multiple MyelomaPhase 2NCT00651937
Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden
A Phase 2 study testing Melphalan, Stem Cell Infusion and Questionnaires in people with Multiple Myeloma and Primary Amyloidosis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn whether higher doses of stem cells can help to decrease the symptoms that occur after melphalan. Another goal of the study is to see how the dose of infused stem cells affects the levels of certain proteins in your blood. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Multiple Myeloma, Primary Amyloidosis
- What is being tested?
- Melphalan, Stem Cell Infusion and Questionnaires
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multiple myeloma over the age of 60 in any of the following disease categories: a) Primary refractory disease b) Consolidation of a first partial or complete remission. OR
- Patients with primary amyloidosis.
- Zubrod PS of <2 or Karnofsky >/= 70.
- Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) >/= 40%. No symptomatic pulmonary disease.
- Serum bilirubin </= 2 X upper limit of normal, serum glutamate pyruvate transaminase (SGPT) </= 4 X upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites >1L prior to drainage.
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- HIV-negative.
- Patient is not pregnant.
- Patient or guardian able to sign informed consent.
- Have greater than or equal to 10 x 10 e 6 CD34+ cells per kg of autologous stem cells cryopreserved for stem cell transplantation, procured with 5 or fewer apheresis collections.
Who cannot join
- 1) Patients unable to perform MDASI assessments due to language or cultural barriers.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Randomized Phase II Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden in High Risk Patients With Multiple Myeloma or Amyloidosis
The goal of this clinical research study is to learn whether higher doses of stem cells can help to decrease the symptoms that occur after melphalan. Another goal of the study is to see how the dose of infused stem cells affects the levels of certain proteins in your blood. Researchers also want to learn how the dose of stem cells that you receive affects the quality of your life during the weeks after the transplant procedure.
Read the detailed description
Stem cells are found in the bone marrow and bloodstream, and they rebuild blood, bone marrow, and the immune system. This study uses autologous stem cells, which are stem cells collected from your own blood. Melphalan is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die. Granulocyte-colony stimulating factor (G-CSF) is designed to help the bone marrow to make more white blood cells. G-CSF is used in this study to help move your stem cells out of the bone marrow and into the bloodstream. If your doctor decides it is needed, you will also receive chemotherapy to help your blood stem cells move out of your bone marrow and into your blood. This allows the stems cells to be collected. Researchers also want to learn how the dose of infused stem cells affects the levels of certain cytokines in your blood. Cytokines are proteins that can cause symptoms such as fatigue and fever.
Treatment Plan:
If you are found to be eligible to take part in this study, you will need to have a central venous catheter (CVC) placed. A CVC is a flexible sterile tube that will be placed into a large vein that runs under your collarbone. Having the CVC allows blood to be drawn and medications to be given more easily and with less discomfort. You will be asked to sign a separate consent form to have the CVC placed, and the procedure will be more fully explained to you at that time.
If your doctor decides it is needed, you will receive chemotherapy to help your blood stem cells move out of your bone marrow and into your blood. You will be asked to sign a separate consent form for this chemotherapy.
Starting on the day of the stem cell infusion, you will receive G-CSF by injection under your skin. You will have the G-CSF injected once or twice a day for about 10 days. The injections may be given at home, if possible. You will be taught how to inject the G-CSF, or someone who agrees to be responsible for giving you the injections may also be taught.
Once the number of stem cells in your bloodstream is high enough, the stem cells will be collected over the course of 2-5 days. You will be asked to sign a separate consent form for the stem cell collection, and the process will be described in more detail at that time. Not counting the blood that is returned to you, about 32 tablespoons of blood will be drawn for the stem cell collection.
You will keep receiving the daily G-CSF injections on the days that your stem cells are collected. A procedure called apheresis will be used to collect the stem cells. During the apheresis, blood will be collected either through your CVC or from a vein in one arm. The blood will be processed through a machine to remove the stem cells, and then the rest of the blood will be returned to you through your CVC or through a vein in the other arm. The apheresis procedure will last several hours each time. You will be asked to sign a separate consent form for the apheresis procedure. You will have enough stem cells collected so that you will be able to have either 1 transplant with high doses of stem cells or 2 transplants with standard doses of stem cells. Your stem cells will be frozen (cryopreserved) until being given back to you.
About 2 weeks after your stem cells have been collected, you will have chemotherapy with melphalan. The melphalan will be given over 30 minutes through your CVC. Since this treatment destroys the normal bone marrow in addition to the myeloma cells, your blood stem cells must be given back to you. This is because blood stem cells are able to refill the bone marrow. If your doctor thinks it is needed, you may be admitted to the hospital the day before you receive melphalan to receive fluids by vein to hydrate you.
Two (2) days after receiving the melphalan, your previously collected stem cells will be unfrozen and given back to you through your CVC, similar to a blood transfusion. This is called an autologous stem cell transplant. You will be randomly assigned (as in the toss of a coin) to receive either a standard amount of stem cells or an experimental amount of stem cells. You have a 50/50 chance of being assigned to either group. After you receive your stem cells, you will be given G-CSF as an injection under the skin. You will keep having G-CSF injections until your white blood cell count returns to normal.
After your stem cells have been given back to you, it will take about 2 weeks for enough blood cells to be made. During this time, it is possible that you might not be making any blood cells. If this happens, you may need to have several red blood cell and platelet transfusions. You will receive antibiotics if infections occur, and you may need to be given feedings through the CVC.
The entire stem cell transplantation process will be done on an outpatient basis, if possible. Otherwise, you may need to stay in the hospital for up to 3-4 weeks.
After the stem cell transplant is completed, you will need to return to the clinic for follow-up visits at least once a week for a month, or more often if the doctor feels it is necessary. The follow-up visits will include the same tests and procedures as is standard of care. Research blood (about 2-4 teaspoons each time) will also be drawn on Day -2, Day 0, Day +3, Day +5, and Day +7; twice a week during weeks 2 and 3; and then once during week 4 for immune system tests.
Questionnaires and Physical Tests:
At several times during the study, you will be asked to complete a questionnaire about your symptoms and quality of life. Sometimes the questionnaire will be done over the phone with an automated phone system. Rating your symptoms using the telephone system should take less than 5 minutes for each call. The rest of the time questionnaires will be performed on paper and through phone interviews. You will also be asked to perform physical tests, including walking for 6 minutes and getting in and out of a chair.
The research nurse will teach you how to use the telephone system for measuring symptoms and your quality of life. You will perform the physical function tests and complete the symptom questionnaire. You will also have tests of the sensitivity of the nerves in your arms and legs. Blood (about 4-5 tablespoons) will be drawn for routine tests. Completing the questionnaires and tasks at this first visit should take about an hour.
During your hospital stay or clinic visits for the stem cell transplant, you will be asked on Day -2 (2 days before the transplant), Day 0, Day +3, Day +5, and Day +7 after the transplant to fill out a paper questionnaire that measures symptoms. You will also be asked on the same days to complete brief tasks that measure physical function.
During Weeks 2 and 3 you will be asked to fill out the paper questionnaire twice a week and complete the tasks of physical function once a week. During Week 4, you will be asked to fill out the questionnaire once and complete the tasks of physical function once. During Week 4, the sensory testing of the nerves in your arms and legs will also be repeated. On the same day as the physical tests, the research nurse will ask you to practice using the telephone system for measuring symptoms.
After you leave the hospital or clinic, the telephone system will call you at home. The calls will occur 1 time a week from Week 5 through Week 12 after the transplant, then 1 time a month during Months 3, 6, and 12 (+/- 1 month). The telephone system will ask you to rate how strong and tolerable the symptoms are, and how much the symptoms interfere with your daily life.
During the clinic visit that occurs about 90 days after the transplant, you will be asked to complete brief tasks that measure physical function, and you will also have the last test of the nerves in your arms and legs.
You will be on study for about 1 year.
This is an investigational study. Melphalan with autologous stem cell transplantation is FDA-approved for the treatment of myeloma and amyloidosis. The medications and treatment for this study are all commercially available. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Multiple Myeloma, Primary Amyloidosis
- Being tested
- Melphalan, Stem Cell Infusion, Questionnaires, Granulocyte-colony stimulating factor (G-CSF), Apheresis
- Keywords
- Multiple Myeloma, Primary Amyloidosis, Cytokine Modulation, Melphalan, Alkeran, Transplant Induced Symptoms, Stem Cell Infusion, Autologous stem cell transplant, ASCT, Granulocyte-colony stimulating factor, G-CSF, Apheresis
- Medical subject headings
- Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
Also called Alkeran
100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion.
Stem Cell InfusionProcedure or surgery
Also called Autologous Stem Cell Transplant, ASCT
Stem Cell Infusion is Day 0.
Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0
High Dose (Arm 2) = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0.
QuestionnairesBehavioural
Also called Survey, Automated Phone Interview, M.D. Anderson Symptom Inventory, MDASI
Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
Granulocyte-colony stimulating factor (G-CSF)Drug
5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days.
ApheresisProcedure or surgery
Collection of stem cells from blood collected either through CVC or from a vein in one arm.
| Study group | Role | What they receive |
|---|---|---|
| Standard Dose | Active comparator | Melphalan + Stem Cell Infusion (Standard Dose): Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10^6 cluster of differentiation 34 (CD34)/kg on Day 0. Melphalan 100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires. Receives: Drug: Melphalan; Procedure: Stem Cell Infusion; Behavioral: Questionnaires; Drug: Granulocyte-colony stimulating factor (G-CSF); Procedure: Apheresis |
| High Dose | Active comparator | Melphalan + Stem Cell Infusion (High Dose): High Dose (Arm 2) = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0. Melphalan 100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires. Receives: Drug: Melphalan; Procedure: Stem Cell Infusion; Behavioral: Questionnaires; Drug: Granulocyte-colony stimulating factor (G-CSF); Procedure: Apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Symptom Severity Burden as Measured by MDASI Scores
MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive symptoms on 0 to 10 numeric scales from "not present" (score of 0) to "as bad as you can imagine" (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from "did not interfere" (Score of 0) to interfered completely (score of 10).
Measured: The first 7 days post-transplant.
Mean Symptom Severity Burden as Measured by MDASI Scores
MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive on 0 to 10 numeric scales from "not present" (score of 0) to "as bad as you can imagine" (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from "did not interfere" (Score of 0) to interfered completely (score of 10)
Measured: 28 day course of ASCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2016
- Study completionJan 2016
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Shah, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651937
- Sponsor's protocol ID
- 2005-0601
- Other IDs
- NCI-2012-01687
- Status last verified
- Jan 2020
- First submitted
- 31 Mar 2008
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden in High Risk Patients With Multiple Myeloma or Amyloidosis
- ClinicalTrials.gov ID
- NCT00651937
- Acronym / sponsor ID
- 2005-0601
- Conditions
- Multiple Myeloma, Primary Amyloidosis
- Keywords
- Multiple Myeloma, Primary Amyloidosis, Cytokine Modulation, Melphalan, Alkeran, Transplant Induced Symptoms, Stem Cell Infusion, Autologous stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Posted 14 Jan 2020
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 whether higher doses of stem cells can help to decrease the symptoms that occur after melphalan. Another goal of the study is to see how the dose of infused stem cells affects the levels of certain proteins in your blood. Researchers also want to learn how the dose of stem cells that you receive affects the quality of your life during the weeks after the transplant procedure.
Detailed description
Stem cells are found in the bone marrow and bloodstream, and they rebuild blood, bone marrow, and the immune system. This study uses autologous stem cells, which are stem cells collected from your own blood. Melphalan is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die. Granulocyte-colony stimulating factor (G-CSF) is designed to help the bone marrow to make more white blood cells. G-CSF is used in this study to help move your stem cells out of the bone marrow and into the bloodstream. If your doctor decides it is needed, you will also receive chemotherapy to help your blood stem cells move out of your bone marrow and into your blood. This allows the stems cells to be collected. Researchers also want to learn how the dose of infused stem cells affects the levels of certain cytokines in your blood. Cytokines are proteins that can cause symptoms such as fatigue and fever.
Treatment Plan:
If you are found to be eligible to take part in this study, you will need to have a central venous catheter (CVC) placed. A CVC is a flexible sterile tube that will be placed into a large vein that runs under your collarbone. Having the CVC allows blood to be drawn and medications to be given more easily and with less discomfort. You will be asked to sign a separate consent form to have the CVC placed, and the procedure will be more fully explained to you at that time.
If your doctor decides it is needed, you will receive chemotherapy to help your blood stem cells move out of your bone marrow and into your blood. You will be asked to sign a separate consent form for this chemotherapy.
Starting on the day of the stem cell infusion, you will receive G-CSF by injection under your skin. You will have the G-CSF injected once or twice a day for about 10 days. The injections may be given at home, if possible. You will be taught how to inject the G-CSF, or someone who agrees to be responsible for giving you the injections may also be taught.
Once the number of stem cells in your bloodstream is high enough, the stem cells will be collected over the course of 2-5 days. You will be asked to sign a separate consent form for the stem cell collection, and the process will be described in more detail at that time. Not counting the blood that is returned to you, about 32 tablespoons of blood will be drawn for the stem cell collection.
You will keep receiving the daily G-CSF injections on the days that your stem cells are collected. A procedure called apheresis will be used to collect the stem cells. During the apheresis, blood will be collected either through your CVC or from a vein in one arm. The blood will be processed through a machine to remove the stem cells, and then the rest of the blood will be returned to you through your CVC or through a vein in the other arm. The apheresis procedure will last several hours each time. You will be asked to sign a separate consent form for the apheresis procedure. You will have enough stem cells collected so that you will be able to have either 1 transplant with high doses of stem cells or 2 transplants with standard doses of stem cells. Your stem cells will be frozen (cryopreserved) until being given back to you.
About 2 weeks after your stem cells have been collected, you will have chemotherapy with melphalan. The melphalan will be given over 30 minutes through your CVC. Since this treatment destroys the normal bone marrow in addition to the myeloma cells, your blood stem cells must be given back to you. This is because blood stem cells are able to refill the bone marrow. If your doctor thinks it is needed, you may be admitted to the hospital the day before you receive melphalan to receive fluids by vein to hydrate you.
Two (2) days after receiving the melphalan, your previously collected stem cells will be unfrozen and given back to you through your CVC, similar to a blood transfusion. This is called an autologous stem cell transplant. You will be randomly assigned (as in the toss of a coin) to receive either a standard amount of stem cells or an experimental amount of stem cells. You have a 50/50 chance of being assigned to either group. After you receive your stem cells, you will be given G-CSF as an injection under the skin. You will keep having G-CSF injections until your white blood cell count returns to normal.
After your stem cells have been given back to you, it will take about 2 weeks for enough blood cells to be made. During this time, it is possible that you might not be making any blood cells. If this happens, you may need to have several red blood cell and platelet transfusions. You will receive antibiotics if infections occur, and you may need to be given feedings through the CVC.
The entire stem cell transplantation process will be done on an outpatient basis, if possible. Otherwise, you may need to stay in the hospital for up to 3-4 weeks.
After the stem cell transplant is completed, you will need to return to the clinic for follow-up visits at least once a week for a month, or more often if the doctor feels it is necessary. The follow-up visits will include the same tests and procedures as is standard of care. Research blood (about 2-4 teaspoons each time) will also be drawn on Day -2, Day 0, Day +3, Day +5, and Day +7; twice a week during weeks 2 and 3; and then once during week 4 for immune system tests.
Questionnaires and Physical Tests:
At several times during the study, you will be asked to complete a questionnaire about your symptoms and quality of life. Sometimes the questionnaire will be done over the phone with an automated phone system. Rating your symptoms using the telephone system should take less than 5 minutes for each call. The rest of the time questionnaires will be performed on paper and through phone interviews. You will also be asked to perform physical tests, including walking for 6 minutes and getting in and out of a chair.
The research nurse will teach you how to use the telephone system for measuring symptoms and your quality of life. You will perform the physical function tests and complete the symptom questionnaire. You will also have tests of the sensitivity of the nerves in your arms and legs. Blood (about 4-5 tablespoons) will be drawn for routine tests. Completing the questionnaires and tasks at this first visit should take about an hour.
During your hospital stay or clinic visits for the stem cell transplant, you will be asked on Day -2 (2 days before the transplant), Day 0, Day +3, Day +5, and Day +7 after the transplant to fill out a paper questionnaire that measures symptoms. You will also be asked on the same days to complete brief tasks that measure physical function.
During Weeks 2 and 3 you will be asked to fill out the paper questionnaire twice a week and complete the tasks of physical function once a week. During Week 4, you will be asked to fill out the questionnaire once and complete the tasks of physical function once. During Week 4, the sensory testing of the nerves in your arms and legs will also be repeated. On the same day as the physical tests, the research nurse will ask you to practice using the telephone system for measuring symptoms.
After you leave the hospital or clinic, the telephone system will call you at home. The calls will occur 1 time a week from Week 5 through Week 12 after the transplant, then 1 time a month during Months 3, 6, and 12 (+/- 1 month). The telephone system will ask you to rate how strong and tolerable the symptoms are, and how much the symptoms interfere with your daily life.
During the clinic visit that occurs about 90 days after the transplant, you will be asked to complete brief tasks that measure physical function, and you will also have the last test of the nerves in your arms and legs.
You will be on study for about 1 year.
This is an investigational study. Melphalan with autologous stem cell transplantation is FDA-approved for the treatment of myeloma and amyloidosis. The medications and treatment for this study are all commercially available. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dose | Active comparator | Drug: Melphalan, Procedure: Stem Cell Infusion, Behavioral: Questionnaires, Drug: Granulocyte-colony stimulating factor (G-CSF), Procedure: ApheresisMelphalan + Stem Cell Infusion (Standard Dose): Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10^6 cluster of differentiation 34 (CD34)/kg on Day 0. Melphalan 100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires. |
| High Dose | Active comparator | Drug: Melphalan, Procedure: Stem Cell Infusion, Behavioral: Questionnaires, Drug: Granulocyte-colony stimulating factor (G-CSF), Procedure: ApheresisMelphalan + Stem Cell Infusion (High Dose): High Dose (Arm 2) = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0. Melphalan 100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with multiple myeloma over the age of 60 in any of the following disease categories: a) Primary refractory disease b) Consolidation of a first partial or complete remission. OR
- Patients with primary amyloidosis.
- Zubrod PS of <2 or Karnofsky >/= 70.
- Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) >/= 40%. No symptomatic pulmonary disease.
Key exclusion criteria (1 listed)
- 1) Patients unable to perform MDASI assessments due to language or cultural barriers.
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 |
|---|---|---|
| MelphalanAlso: Alkeran100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. | Drug | High Dose, Standard Dose |
| Stem Cell InfusionAlso: Autologous Stem Cell Transplant, ASCTStem Cell Infusion is Day 0. Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0 High Dose (Arm 2) = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0. | Procedure or surgery | High Dose, Standard Dose |
| QuestionnairesAlso: Survey, Automated Phone Interview, M.D. Anderson Symptom Inventory, MDASIBeginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires. | Behavioural | High Dose, Standard Dose |
| Granulocyte-colony stimulating factor (G-CSF)5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. | Drug | High Dose, Standard Dose |
| ApheresisCollection of stem cells from blood collected either through CVC or from a vein in one arm. | Procedure or surgery | High Dose, Standard Dose |
Primary outcome
Mean Symptom Severity Burden as Measured by MDASI Scores
Time frame: The first 7 days post-transplant.
MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive symptoms on 0 to 10 numeric scales from "not present" (score of 0) to "as bad as you can imagine" (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from "did not interfere" (Score of 0) to interfered completely (score of 10).
Mean Symptom Severity Burden as Measured by MDASI Scores
Time frame: 28 day course of ASCT
MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive on 0 to 10 numeric scales from "not present" (score of 0) to "as bad as you can imagine" (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from "did not interfere" (Score of 0) to interfered completely (score of 10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Nina Shah, MD principal investigator
M.D. Anderson 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 Melphalan, Stem Cell Infusion and Questionnaires in people with Multiple Myeloma and Primary Amyloidosis, run by M.D. Anderson Cancer 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 10 inclusion and 1 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 14 Jan 2020. 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 14 Jan 2020). 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?
Mean Symptom Severity Burden as Measured by MDASI Scores (time frame: The first 7 days post-transplant.). 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 14 Jan 2020.