Newly Diagnosed Multiple MyelomaPhase 2/3NCT06324266
Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation
A Phase 2/3 study testing Cyclophosphamide and Lenalidomide in people with Newly Diagnosed Multiple Myeloma, run by Jinling Hospital, China at 1 site in China.
Trial summary
The investigators will conduct randomized and controlled clinical studies in order to preliminarily explore the efficacy and safety of low-dose cyclophosphamide and lenalidomide in maintenance therapy for MM that is not suitable for transplantation in the standard-risk group. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma
- What is being tested?
- Cyclophosphamide and Lenalidomide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2023to 31 Dec 2025
- Phase
- Phase 2/3
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After induction and consolidation therapy (8 courses of chemotherapy), MM patients in the standard-risk group who were initially unsuitable for transplantation achieved a therapeutic effect of VGPR or above;
- Secretory MM with measurable indicators;
- Age ≥ 18 years old, gender unlimited;
- No obvious dysfunction of heart, lungs, etc. (≤ Grade I);
- General KPS ≥ 70% (excluding those caused by pathological fractures and bone pain).
Who cannot join
- Cytogenetic high-risk patients;
- Recurrent or refractory MM;
- Using autologous hematopoietic stem cell transplantation as a consolidation therapy;
- The therapeutic effect did not reach VGPR or above before enrollment;
- Asymptomatic MM;
- No measurable indicators;
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- KPS<50%(excluding those caused by pathological fractures）；
- Dysfunction of heart, lungs, etc. (> Grade I);
- Unable to cooperate in observing adverse reactions and therapeutic effects;
- Pregnancy, breastfeeding, or refusal of contraception by women;
- There is drug abuse and medical, psychological, or social conditions that may interfere with patients participating in research or evaluating research results;
- Any unstable or potentially endangering patient safety and compliance with the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu
Zhao Qian, 18251835035, 540598707@qq.com
About this study
Official title: Study on the Efficacy and Safety of Low-dose Cyclophosphamide as Maintenance Therapy for Multiple Myeloma Unsuitable for Transplantation
The investigators will conduct randomized and controlled clinical studies in order to preliminarily explore the efficacy and safety of low-dose cyclophosphamide and lenalidomide in maintenance therapy for MM that is not suitable for transplantation in the standard-risk group.
Read the detailed description
The investigators will conduct randomized and controlled clinical studies to preliminarily explore the efficacy and safety of low-dose cyclophosphamide in maintenance therapy for MM that is not suitable for transplantation in the standard -risk group. Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy will use cyclophosphamide or lenalidomide as maintain therapy for 2 years.
- Conditions
- Newly Diagnosed Multiple Myeloma
- Being tested
- Cyclophosphamide, Lenalidomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called CTX
Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy and are not suitable transplantation, are maintained with Cyclophosphamide monotherapy for 2 years.
LenalidomideDrug
Also called Len
Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy and are not suitable transplantation, are maintained with Lenalidomide monotherapy for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| arm CTX | Experimental | Cyclophosphamide monotherapy: CTX, 0.1g×7days，1/every other week, 28 days per course of treatment,total two years Receives: Drug: Cyclophosphamide |
| arm Len | Placebo comparator | Lenalidomide monotherapy:Len,10mg/day×21days， 28 days per course of treatment,total two years Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS1
Progression-free Survival 1
Measured: 3 years
Secondary outcomes (2)
Incidence of Efficacy as assessed by IMWG
Efficacy assessed by IMWG
Measured: 3 years
Incidence of Safety as assessed by CTCAE 4.0
Safety assessed by CTCAE 4.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start16 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Li, Jinling Hospital, China
- Investigators
- Li Feng, Doctor, Principal investigator, Department of Hematology of Jinling Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324266
- Sponsor's protocol ID
- 2023NZKY-044-02
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Low-dose Cyclophosphamide as Maintenance Therapy for Multiple Myeloma Unsuitable for Transplantation
- ClinicalTrials.gov ID
- NCT06324266
- Acronym / sponsor ID
- 2023NZKY-044-02
- Conditions
- Newly Diagnosed Multiple Myeloma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 16 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Mar 2024 (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.
The investigators will conduct randomized and controlled clinical studies in order to preliminarily explore the efficacy and safety of low-dose cyclophosphamide and lenalidomide in maintenance therapy for MM that is not suitable for transplantation in the standard-risk group.
Detailed description
The investigators will conduct randomized and controlled clinical studies to preliminarily explore the efficacy and safety of low-dose cyclophosphamide in maintenance therapy for MM that is not suitable for transplantation in the standard -risk group. Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy will use cyclophosphamide or lenalidomide as maintain therapy for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm CTX | Experimental | Drug: CyclophosphamideCyclophosphamide monotherapy: CTX, 0.1g×7days，1/every other week, 28 days per course of treatment,total two years |
| arm Len | Placebo comparator | Drug: LenalidomideLenalidomide monotherapy:Len,10mg/day×21days， 28 days per course of treatment,total two years |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- After induction and consolidation therapy (8 courses of chemotherapy), MM patients in the standard-risk group who were initially unsuitable for transplantation achieved a therapeutic effect of VGPR or above;
- Secretory MM with measurable indicators;
- Age ≥ 18 years old, gender unlimited;
- No obvious dysfunction of heart, lungs, etc. (≤ Grade I);
- General KPS ≥ 70% (excluding those caused by pathological fractures and bone pain).
Key exclusion criteria (12 listed)
- Cytogenetic high-risk patients;
- Recurrent or refractory MM;
- Using autologous hematopoietic stem cell transplantation as a consolidation therapy;
- The therapeutic effect did not reach VGPR or above before enrollment;
- Asymptomatic MM;
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 |
|---|---|---|
| CyclophosphamideAlso: CTXStandard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy and are not suitable transplantation, are maintained with Cyclophosphamide monotherapy for 2 years. | Drug | arm CTX |
| LenalidomideAlso: LenStandard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy and are not suitable transplantation, are maintained with Lenalidomide monotherapy for 2 years. | Drug | arm Len |
Primary outcome
PFS1
Time frame: 3 years
Progression-free Survival 1
2 secondary outcomes
Incidence of Efficacy as assessed by IMWG
Time frame: 3 years
Incidence of Safety as assessed by CTCAE 4.0
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Li Feng, Doctor principal investigator
Department of Hematology of Jinling Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cyclophosphamide and Lenalidomide in people with Newly Diagnosed Multiple Myeloma, run by Jinling Hospital, China 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Qian (18251835035, 540598707@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS1 (time frame: 3 years). 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 21 Mar 2024.