Multiple MyelomaMMNCT01572688
Safety and Efficacy Study of High Dose Melphalan to Treat Multiple Myeloma
A study testing Melphalan in people with Multiple Myeloma, run by Shandong Lanjin Pharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of melphalan for injection for autologous stem cell transplant in multiple myeloma Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Melphalan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Jun 2014
- Phase
- Interventional
- 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
- Patients with greater or equal to 18 years, with a upper age limit of 65 years are eligible.
- Multiple myeloma patients, symptoms conform to diagnosis of multiple myeloma of IMWG2003/WHO2008 criteria.
- Patients with responsive disease after induction therapy not more than 6 courses of treatment
- A complete response
- A very good partial response
- A partial response
Show all 14Show fewer
- At least 4 weeks long from last cytotoxic treatment(exclude Bortezomib, thalidomide, dexamethasone);
- Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 Patient has an absolute neutrophil count of ≥1.5×109/L and platelet count≥80×109/L;
- Calculated creatinine clearance >50ml/min by Cockcroft-Gault formula or collect urine within 24 hours.
- Patient with a total bilirubin ≤1.5 times of normal upper limit, AST,ALT≤2.5times of normal upper limit;
- Cardio-pulmonary function is adequate to conduct autologous stem cell transplant.
- Ratio of body weight and ideal body weight <175%;
- All patients should have a life expectancy of more than 12 weeks
- Signed informed consent form voluntarily
Who cannot join
- CD34 positive hematopoietic stem cell collected <2.0×106/kg
- Patients have a psychiatric history
- Female subject is pregnant or breast-feeding
- Patients are hypersensitive to this trial product or other alkylating agents
- Participate of other clinical trials within the past 4 weeks Active CNS lesions
- Concomitant of active infection or positive of HIV antibody
Show all 11Show fewer
- Concomitant of other un-healed malignancy
- Left ventricular ejection fraction≤50%
- Patients with serious thrombosis
- Any severe concomitant disease that will expose study subjects to unacceptable risks.
- Patients not suitable to enroll by investigators considerations.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hematologic Hospital of Chinese Academy of Medical Sciences
Tianjin
Lu G Qiu, +86-022-23909172
Jian J Yu, Master, +8615336402751, yujj@lanjin.cn
About this study
Official title: A Multicenter, Single Arm, Open Label Study of Autologous Stem Cell Transplantation With High Dose Melphalan in Patients With Multiple Myeloma
The purpose of the study is to evaluate the safety and effectiveness of melphalan for injection for autologous stem cell transplant in multiple myeloma
- Conditions
- Multiple Myeloma
- Being tested
- Melphalan
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
powder for injection, 200mg/m2, uses after reconstituted within 24 hours
| Study group | Role | What they receive |
|---|---|---|
| autologous stem cell transplant | Experimental | Not described Receives: Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year Progression Free Survival
Plan to enroll all trial subjects within 8 months and follow up 1 year for each subject after enrollment
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Lanjin Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, master, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572688
- Sponsor's protocol ID
- RG0276
- Acronym
- MM
- Status last verified
- Apr 2012
- First submitted
- 4 Apr 2012
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single Arm, Open Label Study of Autologous Stem Cell Transplantation With High Dose Melphalan in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01572688
- Acronym / sponsor ID
- MM / RG0276
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong Lanjin Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 6 Apr 2012 (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 purpose of the study is to evaluate the safety and effectiveness of melphalan for injection for autologous stem cell transplant in multiple myeloma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous stem cell transplant | Experimental | Drug: Melphalan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with greater or equal to 18 years, with a upper age limit of 65 years are eligible.
- Multiple myeloma patients, symptoms conform to diagnosis of multiple myeloma of IMWG2003/WHO2008 criteria.
- Patients with responsive disease after induction therapy not more than 6 courses of treatment
- A complete response
- A very good partial response
Key exclusion criteria (11 listed)
- CD34 positive hematopoietic stem cell collected <2.0×106/kg
- Patients have a psychiatric history
- Female subject is pregnant or breast-feeding
- Patients are hypersensitive to this trial product or other alkylating agents
- Participate of other clinical trials within the past 4 weeks Active CNS lesions
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 |
|---|---|---|
| Melphalanpowder for injection, 200mg/m2, uses after reconstituted within 24 hours | Drug | autologous stem cell transplant |
Primary outcome
1 year Progression Free Survival
Time frame: 20 months
Plan to enroll all trial subjects within 8 months and follow up 1 year for each subject after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Lugui Qiu, master principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melphalan in people with Multiple Myeloma, run by Shandong Lanjin Pharmaceuticals Co.,Ltd 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 14 inclusion and 11 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 2 Aug 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year Progression Free Survival (time frame: 20 months). 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 2 Aug 2012.