Multiple MyelomaNCT05970198
Helical Tomotherapy in Multiple Myeloma
A study testing Total Marrow irradiation，TMI and Autologous hematopoietic stem cell transplantation in people with Multiple Myeloma, run by Fuling Zhou at 1 site in China.
Trial summary
To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Total Marrow irradiation，TMI and Autologous hematopoietic stem cell transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple myeloma patients receiving induction therapy and stem cell mobilization preparation for autologous transplantation;
- Should agree to comply with all contraceptive requirements; 3, ECOG≤2;
- 4. Total bilirubin, ALT and AST <2×UNL (upper limit of normal), BUN < 30 mg/dL; 5. At least 2 x 10^6 CD34+ cells /kg were collected; 6.absolute neutrophil count >1000/uL and a platelet count of >100,000/uL; 7. The expected survival time is more than 3 months; 8. Written informed consent was obtained from the patients or their immediate family members.
Who cannot join
- Any of the following was an exclusion criterion:
- According to the investigator's judgment, patients who cannot tolerate melphalan and radiotherapy;
- Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or seropositive for human immunodeficiency virus (HIV);
- patients with uncontrolled or severe cardiovascular disease
- According to the protocol or the investigator's judgment, the patient has a serious physical or mental illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Zhou Fuling, director, +86-02767813137, zhoufuling@163.com
About this study
Official title: A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma
To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.
Read the detailed description
This study is a single-center, prospective clinical study targeting myeloma patients requiring transplantation, and investigating the efficacy and safety of TBI combined with Mel regimen for transplant pretreatment. Subjects who meet the enrollment criteria were screened to enter the study and receive the corresponding regimen treatment.
- Conditions
- Multiple Myeloma
- Being tested
- Total Marrow irradiation，TMI, Autologous hematopoietic stem cell transplantation
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Marrow irradiation，TMIRadiation
TMI radiation dose On the 5th day (-5 days) before transplantation, an irradiation dose of 8 Gy is given.
TMI uses a 6-18MV linear accelerator, the patient lies on his side in a single irradiation field, covered with a 1 cm thick plexiglass frame, and the radioactive source is 4 meters away from the body surface of the human side. The anterior and anterior positions were alternately irradiated, and the horizontal beam was irradiated in the opposite direction, and the actual irradiation dose was detected by the thermo-optical element of the 2570 roentgen dosimeter scale, and the irradiation dose of all parts of the body was adjusted to make the abdominal irradiation dose difference within 10%, the total dose was 8Gy, divided into 2 times a day, with an interval of 5 hours, and the dose rate was 4.99-6.96cGy/min.
Autologous hematopoietic stem cell transplantationProcedure or surgery
Autologous hematopoietic stem cell transplantation;Porting method melphalan
| Study group | Role | What they receive |
|---|---|---|
| Autologous hematopoietic stem cell transplantation | Active comparator | Porting method melphalan: recommended dose of 70 mg/m2/day with 2 consecutive days (days -2 and -1) intravenous (IV) for more than 30 minutes each prior to autologous hematopoietic stem cell transplantation (ASCT, day 0). Receives: Procedure: Autologous hematopoietic stem cell transplantation |
| Radiotherapy combined with autologous hematopoietic stem cell transplantation | Experimental | TMI radiation dose On the 5th day (-5 days) before transplantation, an irradiation dose of 8 Gy is given.
TMI uses a 6-18MV linear accelerator, the patient lies on his side in a single irradiation field, covered with a 1 cm thick plexiglass frame, and the radioactive source is 4 meters away from the body surface of the human side. The anterior and anterior positions were alternately irradiated, and the horizontal beam was irradiated in the opposite direction, and the actual irradiation dose was detected by the thermo-optical element of the 2570 roentgen dosimeter scale, and the irradiation dose of all parts of the body was adjusted to make the abdominal irradiation dose difference within 10%, the total dose was 8Gy, divided into 2 times a day, with an interval of 5 hours, and the dose rate was 4.99-6.96cGy/min.Porting method melphalan. Receives: Radiation: Total Marrow irradiation，TMI; Procedure: Autologous hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate and above 100 days after transplantation (≥ CR rate)
Complete response rate and above 100 days after transplantation (≥ CR rate)
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
1-year Progression-free Survival rate
1-year Progression-free Survival rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start14 Jun 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuling Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fuling Zhou, Zhongnan Hospital
- Investigators
- Fuling Zhou, Study director, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970198
- Sponsor's protocol ID
- 08
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05970198
- Acronym / sponsor ID
- 08
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Fuling ZhouUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Aug 2023 (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.
To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.
Detailed description
This study is a single-center, prospective clinical study targeting myeloma patients requiring transplantation, and investigating the efficacy and safety of TBI combined with Mel regimen for transplant pretreatment. Subjects who meet the enrollment criteria were screened to enter the study and receive the corresponding regimen treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous hematopoietic stem cell transplantation | Active comparator | Procedure: Autologous hematopoietic stem cell transplantationPorting method melphalan: recommended dose of 70 mg/m2/day with 2 consecutive days (days -2 and -1) intravenous (IV) for more than 30 minutes each prior to autologous hematopoietic stem cell transplantation (ASCT, day 0). |
| Radiotherapy combined with autologous hematopoietic stem cell transplantation | Experimental | Radiation: Total Marrow irradiation，TMI, Procedure: Autologous hematopoietic stem cell transplantationTMI radiation dose On the 5th day (-5 days) before transplantation, an irradiation dose of 8 Gy is given. TMI uses a 6-18MV linear accelerator, the patient lies on his side in a single irradiation field, covered with a 1 cm thick plexiglass frame, and the radioactive source is 4 meters away from the body surface of the human side. The anterior and anterior positions were alternately irradiated, and the horizontal beam was irradiated in the opposite direction, and the actual irradiation dose was detected by the thermo-optical element of the 2570 roentgen dosimeter scale, and the irradiation dose of all parts of the body was adjusted to make the abdominal irradiation dose difference within 10%, the total dose was 8Gy, divided into 2 times a day, with an interval of 5 hours, and the dose rate was 4.99-6.96cGy/min.Porting method melphalan. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Multiple myeloma patients receiving induction therapy and stem cell mobilization preparation for autologous transplantation;
- Should agree to comply with all contraceptive requirements; 3, ECOG≤2;
- 4. Total bilirubin, ALT and AST <2×UNL (upper limit of normal), BUN < 30 mg/dL; 5. At least 2 x 10^6 CD34+ cells /kg were collected; 6.absolute neutrophil count >1000/uL and a platelet count of >100,000/uL; 7. The expected survival time is more than 3 months; 8. Written informed consent was obtained from the patients or their immediate family members.
Key exclusion criteria (5 listed)
- According to the investigator's judgment, patients who cannot tolerate melphalan and radiotherapy;
- Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or seropositive for human immunodeficiency virus (HIV);
- patients with uncontrolled or severe cardiovascular disease
- According to the protocol or the investigator's judgment, the patient has a serious physical or mental illness
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 |
|---|---|---|
| Total Marrow irradiation，TMITMI radiation dose On the 5th day (-5 days) before transplantation, an irradiation dose of 8 Gy is given. TMI uses a 6-18MV linear accelerator, the patient lies on his side in a single irradiation field, covered with a 1 cm thick plexiglass frame, and the radioactive source is 4 meters away from the body surface of the human side. The anterior and anterior positions were alternately irradiated, and the horizontal beam was irradiated in the opposite direction, and the actual irradiation dose was detected by the thermo-optical element of the 2570 roentgen dosimeter scale, and the irradiation dose of all parts of the body was adjusted to make the abdominal irradiation dose difference within 10%, the total dose was 8Gy, divided into 2 times a day, with an interval of 5 hours, and the dose rate was 4.99-6.96cGy/min. | Radiation | Radiotherapy combined with autologous hematopoietic stem cell transplantation |
| Autologous hematopoietic stem cell transplantationAutologous hematopoietic stem cell transplantation;Porting method melphalan | Procedure or surgery | Autologous hematopoietic stem cell transplantation, Radiotherapy combined with autologous hematopoietic stem cell transplantation |
Primary outcome
Complete response rate and above 100 days after transplantation (≥ CR rate)
Time frame: through study completion, an average of 1 year
Complete response rate and above 100 days after transplantation (≥ CR rate)
1 secondary outcome
1-year Progression-free Survival rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Recruiting
HEME Home Transfusion Program
Leukemia, Myeloma
RecruitingPhase 2
Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse
Recurrent Multiple Myeloma, Refractory Multiple Myeloma
Not yet recruitingPhase 2
Elranatamab With Mezigdomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma Refractory, Multiple Myeloma in Relapse
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
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.
Fuling Zhou study director
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Marrow irradiation，TMI and Autologous hematopoietic stem cell transplantation in people with Multiple Myeloma, run by Fuling Zhou at 1 site in China.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 Aug 2023. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuling Zhou (+86-02767813137, zhoufuling@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate and above 100 days after transplantation (≥ CR rate) (time frame: through study completion, an average of 1 year). 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 1 Aug 2023.