Multiple MyelomaPhase 1NCT00985959
A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
A Phase 1 study testing JNJ-26866138 0.7 mg/m2, JNJ-26866138 1.0 mg/m2 and JNJ-26866138 1.3 mg/m2 in people with Multiple Myeloma, run by Janssen Pharmaceutical K.K. at 28 sites in Japan.
Trial summary
The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- JNJ-26866138 0.7 mg/m2, JNJ-26866138 1.0 mg/m2 and JNJ-26866138 1.3 mg/m2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 28 sitesJapan
- Study dates
- Jul 2008to Jun 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with symptomatic or nonsecretory multiple myeloma
- Participants who have not received chemotherapy and are not hematopoietic stem cell transplantation candidates
- Participants with a measurable lesion
- Life expectancy greater than or equal to 3 months
Who cannot join
- Previously received treatment for Multiple Myeloma
- Greater than or equal to Grade 2 peripheral neuropathy or neuropathic pain
- Myocardial infarction within 6 months prior to enrollment or uncontrolled angina, severe uncontrolled ventricular arrhythmias, or clinically significant conduction system abnormalities
- Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection
- Active prior malignancy diagnosed within the last 5 years
- Female participant who is pregnant or breast-feeding
- Participant is enrolled in another clinical research study and/or is receiving an investigational agent
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Japan28 sites
Study site
Fukuoka
Study site
Hiroshima
Study site
Hitachi
Study site
Isehara
Study site
Kamogawa
Study site
Kanazawa
Study site
Kawagoe
Study site
Kobe
Study site
Kōtoku
Study site
Kumamoto
Study site
Kurashiki
Study site
Kurume
Study site
Kyoto
Study site
Nagasaki
Study site
Nagoya
Study site
Narita
Study site
Niigata
Study site
Okayama
Study site
Ōsaka-sayama
Study site
Sapporo
Study site
Shibukawa
Study site
Suita
Study site
Tokushima
Study site
Tokyo
Study site
Toyama
Study site
Toyohashi
Study site
Utsunomiya
Study site
Yokohama
About this study
Official title: A Phase I/II Clinical Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion).
Read the detailed description
This is an open-label (both physician and participant know the intervention), non-randomized (participants are not assigned by chance), multi-center study in untreated multiple myeloma participants who were not candidates for hematopoietic stem cell transplant. This study consists of two parts: Phase I and Phase II. In Phase I, a total of 18 participants will be enrolled ie, 6 patients per dose level (0.7, 1.0 and 1.3 mg/m2) to determine the recommended dose of bortezomib. In Phase II, additional 83 participants will be enrolled. Safety evaluations will include assessment of adverse events, clinical laboratory test, specifically hematological toxicities.
- Conditions
- Multiple Myeloma
- Being tested
- JNJ-26866138 0.7 mg/m2, JNJ-26866138 1.0 mg/m2, JNJ-26866138 1.3 mg/m2, Melphalan, Prednisolone
- Keywords
- Multiple myeloma, Hematopoietic stem cell transplant, HSCT, Melphalan, Prednisolone, Bortezomib, JNJ-26866138
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-26866138 0.7 mg/m2Drug
Also called bortezomib
JNJ-26866138 0.7 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles.
JNJ-26866138 1.0 mg/m2Drug
Also called bortezomib
JNJ-26866138 1.0 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles
JNJ-26866138 1.3 mg/m2Drug
Also called bortezomib
Phase I: JNJ-26866138 1.3 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5 to 9 cycles.
MelphalanDrug
Melphalan 9 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
PrednisoloneDrug
Prednisolone 60 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
| Study group | Role | What they receive |
|---|---|---|
| Phase I: JNJ-26866138 0.7 mg/m2 | Experimental | JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Receives: Drug: JNJ-26866138 0.7 mg/m2; Drug: Melphalan; Drug: Prednisolone |
| Phase I: JNJ-26866138 1.0 mg/m2 | Experimental | JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles Receives: Drug: JNJ-26866138 1.0 mg/m2; Drug: Melphalan; Drug: Prednisolone |
| Phase I: JNJ-26866138 1.3 mg/m2 | Experimental | JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles Receives: Drug: JNJ-26866138 1.3 mg/m2; Drug: Melphalan; Drug: Prednisolone |
| Phase II: JNJ-26866138 1.3 mg/m2 | Experimental | JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles Receives: Drug: JNJ-26866138 1.3 mg/m2; Drug: Melphalan; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)
Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1
Measured: 6 weeks
Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II
Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein for at least 2 determinations 6 weeks apart; If present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg for at least 2 determinations 6 weeks apart; ≥50% reduction in the size of soft tissue plasmacytomas for at least 6 weeks; no increase in size or number of lytic bone lesions
Measured: 54 weeks
Secondary outcomes (5)
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I
Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 1/Day 25 (JNJ-26866138 alone)
Measured: Day 25 of Cycle 1
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I
Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 2/Day 4 (combination with melphalan and prednisolone)
Measured: Day 4 of Cycle 2
Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I
Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4
Measured: Day 4 of Cycle 2
Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I
Cmax of Prednisolone at dose of 60 mg/m2 on Cycle 2/Day 4
Measured: Day 4 of Cycle 2
Median Time to First Response - Phase II
Time to first response is the duartion of time required to achieve first response to treatment
Measured: up to 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startJul 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985959
- Sponsor's protocol ID
- CR014776
- Other IDs
- JNJ-26866138-JPN-MM-102
- Status last verified
- Oct 2013
- First submitted
- 18 Sep 2009
- Last updated
- 2 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
- ClinicalTrials.gov ID
- NCT00985959
- Acronym / sponsor ID
- CR014776
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Hematopoietic stem cell transplant, HSCT, Melphalan, Prednisolone, Bortezomib, JNJ-26866138
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Sep 2009 (estimated)
- Results
- Posted 2 Dec 2013
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 in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion).
Detailed description
This is an open-label (both physician and participant know the intervention), non-randomized (participants are not assigned by chance), multi-center study in untreated multiple myeloma participants who were not candidates for hematopoietic stem cell transplant. This study consists of two parts: Phase I and Phase II. In Phase I, a total of 18 participants will be enrolled ie, 6 patients per dose level (0.7, 1.0 and 1.3 mg/m2) to determine the recommended dose of bortezomib. In Phase II, additional 83 participants will be enrolled. Safety evaluations will include assessment of adverse events, clinical laboratory test, specifically hematological toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I: JNJ-26866138 0.7 mg/m2 | Experimental | Drug: JNJ-26866138 0.7 mg/m2, Drug: Melphalan, Drug: PrednisoloneJNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. |
| Phase I: JNJ-26866138 1.0 mg/m2 | Experimental | Drug: JNJ-26866138 1.0 mg/m2, Drug: Melphalan, Drug: PrednisoloneJNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles |
| Phase I: JNJ-26866138 1.3 mg/m2 | Experimental | Drug: JNJ-26866138 1.3 mg/m2, Drug: Melphalan, Drug: PrednisoloneJNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles |
| Phase II: JNJ-26866138 1.3 mg/m2 | Experimental | Drug: JNJ-26866138 1.3 mg/m2, Drug: Melphalan, Drug: PrednisoloneJNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants diagnosed with symptomatic or nonsecretory multiple myeloma
- Participants who have not received chemotherapy and are not hematopoietic stem cell transplantation candidates
- Participants with a measurable lesion
- Life expectancy greater than or equal to 3 months
Key exclusion criteria (7 listed)
- Previously received treatment for Multiple Myeloma
- Greater than or equal to Grade 2 peripheral neuropathy or neuropathic pain
- Myocardial infarction within 6 months prior to enrollment or uncontrolled angina, severe uncontrolled ventricular arrhythmias, or clinically significant conduction system abnormalities
- Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection
- Active prior malignancy diagnosed within the last 5 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 |
|---|---|---|
| JNJ-26866138 0.7 mg/m2Also: bortezomibJNJ-26866138 0.7 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. | Drug | Phase I: JNJ-26866138 0.7 mg/m2 |
| JNJ-26866138 1.0 mg/m2Also: bortezomibJNJ-26866138 1.0 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles | Drug | Phase I: JNJ-26866138 1.0 mg/m2 |
| JNJ-26866138 1.3 mg/m2Also: bortezomibPhase I: JNJ-26866138 1.3 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5 to 9 cycles. | Drug | Phase I: JNJ-26866138 1.3 mg/m2, Phase II: JNJ-26866138 1.3 mg/m2 |
| MelphalanMelphalan 9 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles | Drug | Phase I: JNJ-26866138 0.7 mg/m2, Phase I: JNJ-26866138 1.0 mg/m2, Phase I: JNJ-26866138 1.3 mg/m2, Phase II: JNJ-26866138 1.3 mg/m2 |
| PrednisolonePrednisolone 60 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles | Drug | Phase I: JNJ-26866138 0.7 mg/m2, Phase I: JNJ-26866138 1.0 mg/m2, Phase I: JNJ-26866138 1.3 mg/m2, Phase II: JNJ-26866138 1.3 mg/m2 |
Primary outcome
Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)
Time frame: 6 weeks
Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1
Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II
Time frame: 54 weeks
Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein for at least 2 determinations 6 weeks apart; If present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg for at least 2 determinations 6 weeks apart; ≥50% reduction in the size of soft tissue plasmacytomas for at least 6 weeks; no increase in size or number of lytic bone lesions
5 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I
Time frame: Day 25 of Cycle 1
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I
Time frame: Day 4 of Cycle 2
Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I
Time frame: Day 4 of Cycle 2
Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I
Time frame: Day 4 of Cycle 2
Median Time to First Response - Phase II
Time frame: up to 54 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Janssen Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-26866138 0.7 mg/m2, JNJ-26866138 1.0 mg/m2 and JNJ-26866138 1.3 mg/m2 in people with Multiple Myeloma, run by Janssen Pharmaceutical K.K. at 28 sites in Japan.
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 4 inclusion and 7 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 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Japan. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 Dec 2013.