Relapsed and/or Refractory Multiple MyelomaPhase 1/2NCT00882063
Study To Evaluate Safety and Efficacy of P276-00 in Subjects With Refractory Multiple Myeloma
A Phase 1/2 study testing P276-00 in people with Relapsed and/or Refractory Multiple Myeloma, run by Piramal Enterprises Limited at 5 sites in India.
Trial summary
The purpose of this study is to determine safety of P276-00 in patients with advanced multiple myeloma and whether P276-00 is effective in the treatment of advanced cases of multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed and/or Refractory Multiple Myeloma
- What is being tested?
- P276-00
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesIndia
- Study dates
- Jan 2008to May 2012
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects previously diagnosed with multiple myeloma based either on the standard diagnostic criteria or the International Myeloma Foundation (IMF) diagnostic criteria as defined in Appendix A.
- Subjects must have relapsed and/or relapsed/refractory disease after at least 2 prior lines of therapy as defined in Appendix D.
- Monoclonal protein in the serum of > or = 1 g/dL or monoclonal light chain in the urine protein electrophoresis of > or = 200 mg/ 24 hours, or measurable light chains by free light chain assay of > or = 10 mg/dL, or measurable plasmacytoma.
- Age > or = 18 years at the time of signing the informed consent form
- ECOG performance status < or = 2
- Life expectancy > or = 3 months
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- Subjects must have the following laboratory parameters:
- Hemoglobin > or = 8.0 gm/dL
- Absolute Neutrophil Count (ANC) > or = 1000 cells/mm3
- Platelets count > or = 50,000/mm3
- Serum SGOT/AST <3.0 x institutional upper limits of normal (ULN)
- Serum SGPT/ALT <3.0 x institutional upper limits of normal (ULN)
- Serum creatinine <2.5mg/dL
- Serum total bilirubin <1.5 x institutional upper limits of normal (ULN)
- Woman of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months) with a negative serum pregnancy test. In addition, all sexually active women of childbearing potential and men agreeing to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects having received radiotherapy, immunotherapy, chemotherapy and/or biological agents like G-CSF in the 4 weeks prior to day 1 of study drug administration or have not recovered (grade < or = 1) from adverse effects of such therapy received prior to 4 weeks
- Subjects having received any other investigational agents within 4 weeks prior to the date of enrolment or have not recovered from adverse effects of the investigational agent received prior to 4 weeks.
- History of allergic reactions attributed to compounds of similar chemical composition to P276-00.
- Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months.
- Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years.
- Subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, cardiac ejection fraction < 40%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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- Women who are pregnant or nursing
- Subjects known to be seropositive for the human immunodeficiency virus or any history or evidence from physical examination of HIV infection.
- Subjects requiring the use of concomitant medications that prolong the QT/QTc interval and/or are known to cause Torsades de Pointes (TdP).
- Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Rajiv Gandhi Cancer Institute And Research Centre
Delhi, National Capital Territory of Delhi, 110085
Netaji Subhash Chandra Bose Cancer Research Institute
Kolkata, West Bengal, 700016
Jaslok Hospital & Research Centre
Mumbai, Maharashtra, 400 026
Shatabdi Superspeciality Hospital
Nashik, Maharashtra, 422002
Institute Rotary Cancer Hospital,All India Institute Of Medical Sciences(AIIMS)
New Delhi, New Delhi, 110029
About this study
Official title: An Open Label, Multicenter Phase I/II Study To Evaluate Safety and Efficacy of P276-00 in Subjects With Relapsed and/or Relapsed/Refractory Multiple Myeloma
The purpose of this study is to determine safety of P276-00 in patients with advanced multiple myeloma and whether P276-00 is effective in the treatment of advanced cases of multiple myeloma.
Read the detailed description
This is an open label multicenter study of P276-00 in subjects with Relapsed and/or Relapsed/Refractory Multiple Myeloma. Cohort of 3 subjects will be enrolled at starting dose of P276-00 which is 50 mg/m2/day to be given intravenously from day 1 to day 5 every 21 days. This 21 day administration constitutes one cycle of P276-00. Six such cycles will be administered to the subjects. If the dose is well tolerated then next cohort will be enrolled at higher dose level of P276-00 till maximum tolerated dose is determined. Safety assessment will be repeated at regular interval and efficacy assessment will be repeated during every cycles.After the subject completes 6 cycles, there will be a follow-up visit after 4 weeks (+1 week) of study completion.Subjects who have stable disease or who have responded (MR, PR or CR) after completion of the 6 cycles will be given the option to continue treatment for a maximum of 12 cycles or until they are deemed to have progressive disease.
- Being tested
- P276-00
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P276-00Drug
Subjects will be enrolled at different dose levels of P276-00 to determine maximum tolerated dose of P276-00.Starting dose level of P276-00 is 50 mg/m2/day to be administered intravenously in 200 ml of 5% dextrose (D5W) over a period of 30 min from day 1 to day 5 every 21 days. This constitutes one cycle of P276-00. Six such cycles will be administered to subjects.
| Study group | Role | What they receive |
|---|---|---|
| P276-00 | Experimental | Starting dose level of P276-00 is 50 mg/m2/day. The drug will be administered intravenously in 200 ml of 5% dextrose (D5W) over a period of 30 min. Subjects will be enrolled at different dose levels of P276-00 to determine maximum tolerated dose of P276-00. Receives: Drug: P276-00 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose of P276-00 in subjects with relapsed and/or relapsed/refractory Multiple Myeloma
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startJan 2008
- Primary completionNov 2009
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or Refractory 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Enterprises Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Himanshu Parikh, M.D., Study director, Vice President- Clinical Research (R & D), Nicholas Piramal Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882063
- Sponsor's protocol ID
- P276-00/15/07
- Status last verified
- Nov 2012
- First submitted
- 15 Apr 2009
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Phase I/II Study To Evaluate Safety and Efficacy of P276-00 in Subjects With Relapsed and/or Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00882063
- Acronym / sponsor ID
- P276-00/15/07
- Keywords
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Piramal Enterprises LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Apr 2009 (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 this study is to determine safety of P276-00 in patients with advanced multiple myeloma and whether P276-00 is effective in the treatment of advanced cases of multiple myeloma.
Detailed description
This is an open label multicenter study of P276-00 in subjects with Relapsed and/or Relapsed/Refractory Multiple Myeloma. Cohort of 3 subjects will be enrolled at starting dose of P276-00 which is 50 mg/m2/day to be given intravenously from day 1 to day 5 every 21 days. This 21 day administration constitutes one cycle of P276-00. Six such cycles will be administered to the subjects. If the dose is well tolerated then next cohort will be enrolled at higher dose level of P276-00 till maximum tolerated dose is determined. Safety assessment will be repeated at regular interval and efficacy assessment will be repeated during every cycles.After the subject completes 6 cycles, there will be a follow-up visit after 4 weeks (+1 week) of study completion.Subjects who have stable disease or who have responded (MR, PR or CR) after completion of the 6 cycles will be given the option to continue treatment for a maximum of 12 cycles or until they are deemed to have progressive disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P276-00 | Experimental | Drug: P276-00Starting dose level of P276-00 is 50 mg/m2/day. The drug will be administered intravenously in 200 ml of 5% dextrose (D5W) over a period of 30 min. Subjects will be enrolled at different dose levels of P276-00 to determine maximum tolerated dose of P276-00. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects previously diagnosed with multiple myeloma based either on the standard diagnostic criteria or the International Myeloma Foundation (IMF) diagnostic criteria as defined in Appendix A.
- Subjects must have relapsed and/or relapsed/refractory disease after at least 2 prior lines of therapy as defined in Appendix D.
- Monoclonal protein in the serum of > or = 1 g/dL or monoclonal light chain in the urine protein electrophoresis of > or = 200 mg/ 24 hours, or measurable light chains by free light chain assay of > or = 10 mg/dL, or measurable plasmacytoma.
- Age > or = 18 years at the time of signing the informed consent form
- ECOG performance status < or = 2
Key exclusion criteria (10 listed)
- Subjects having received radiotherapy, immunotherapy, chemotherapy and/or biological agents like G-CSF in the 4 weeks prior to day 1 of study drug administration or have not recovered (grade < or = 1) from adverse effects of such therapy received prior to 4 weeks
- Subjects having received any other investigational agents within 4 weeks prior to the date of enrolment or have not recovered from adverse effects of the investigational agent received prior to 4 weeks.
- History of allergic reactions attributed to compounds of similar chemical composition to P276-00.
- Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months.
- Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years.
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 |
|---|---|---|
| P276-00Subjects will be enrolled at different dose levels of P276-00 to determine maximum tolerated dose of P276-00.Starting dose level of P276-00 is 50 mg/m2/day to be administered intravenously in 200 ml of 5% dextrose (D5W) over a period of 30 min from day 1 to day 5 every 21 days. This constitutes one cycle of P276-00. Six such cycles will be administered to subjects. | Drug | P276-00 |
Primary outcome
To determine the maximum tolerated dose of P276-00 in subjects with relapsed and/or relapsed/refractory Multiple Myeloma
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
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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.
Himanshu Parikh, M.D. study director
Vice President- Clinical Research (R & D), Nicholas Piramal Research Centre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing P276-00 in people with Relapsed and/or Refractory Multiple Myeloma, run by Piramal Enterprises Limited at 5 sites in India.
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 16 inclusion and 10 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 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the maximum tolerated dose of P276-00 in subjects with relapsed and/or relapsed/refractory Multiple Myeloma (time frame: 18 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 21 Nov 2012.