NMP in Relapsed / Refractory Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02468687|
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : May 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: N-methyl-pyrrolidone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open Label Dose Escalation Trial of Orally Administered N-methyl-pyrrolidone (NMP) in Patients With Relapsed or Refractory Myeloma|
|Actual Study Start Date :||August 20, 2015|
|Actual Primary Completion Date :||October 7, 2021|
|Actual Study Completion Date :||October 7, 2021|
NMP dose escalation in accelerated phase and standard phase
NMP will be taken each morning as a single daily dose of oral suspension at a concentration of 50mg/ml on an empty stomach at least 30 minutes prior to food.
Other Name: NMP
- Adverse events to establish the Maximum Tolerated Dose (MTD) [ Time Frame: 28 days ]Each patient will be monitored for adverse events during the first cycle of NMP treatment (28 days) to establish the maximum tolerated dose
- Optimum biological dose (OBD) [ Time Frame: 6 months ]The maximum changes in correlative biomarkers will be tested at the specific time-points. Descriptive statistics will be used to analyse data from correlative studies and summarized in graphical or tabular formats as appropriate.
- Safety of the repeated dosing of NMP by oral administration - possible toxicities [ Time Frame: 6 months ]To assess safety, the numbers and rates (with confidence intervals) of patients experiencing any haematological and non-haematological and specific grade 3+ adverse events experienced at each given dose level and schedule of NMP will be calculated, over the full treatment period and by cycle
- Pharmacokinetic properties of NMP after oral administration [ Time Frame: Predose,0.5,1,2,4,8, 24 hours post dose ]Pick plasma concentrations (Cmax) of NMP
- Response rate measured using IMWG criteria [ Time Frame: 6 months up to 2 years ]Patients will be evaluated for response after every 28 day cycle for the first 6 cycles of treatment and thereafter every 2 months in follow up using the IMWG criteria for multiple myeloma.
- Time to progression from start of treatment [ Time Frame: up to 3.5 years ]Patients will be assessed for disease progression weekly in Cycle 1, then monthly on D1 of each cycle during treatment for the first 6 months and then monthly until disease progression, next anti-cancer treatment or death. Time to progression from start of treatment will be estimated using Kaplan Meier survival curves.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468687
|Peter MacCallum Cancer Centre|
|Melbourne, Victoria, Australia, 3002|
|Principal Investigator:||David Ritchie, Prof||Melbourne Health|