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AzTrials

Multiple MyelomaPhase 1NCT01464112

A Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ 26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Patients With Relapsed Multiple Myeloma

A Phase 1 study testing JNJ-2641585 / VELCADE / Dexamethasone in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability and to establish the maximum tolerated dose of JNJ-26481585 combined with VELCADE and dexamethasone. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Multiple Myeloma
What is being tested?
JNJ-2641585 / VELCADE / Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
3 sitesFrance
Study dates
16 Sep 2011to 19 Nov 2013
Phase
Phase 1
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) Performance status score 0-2
  • Measurable or secretory multiple myeloma
  • Relapse or progression of myeloma following prior systemic antineoplastic therapy
  • Pretreatment clinical laboratory values meeting protocol-specified criteria
  • Left ventricular ejection fraction rate within normal limits

Who cannot join

  • Peripheral neuropathy or neuralgia >=2, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0
  • Diagnosis of primary amyloidosis, plasma cell leukemia, or other similar conditions
  • Diagnosis of Waldenstrom macroglobulinemia with protocol-specified immunoglobulin levels
  • Prior histone-deacetylase inhibitor therapy - More than 3 prior lines of therapy
  • Cardiac risk factors: unstable angina or myocardial infarction within the preceding 12 months, congestive heart failure (New York Heart Association Class II-IV), known presence of dilated, hypertrophic, or restrictive cardiomyopathy
  • Any other cardiac abnormality that, in the opinion of the investigator, medical monitor, or consultant cardiologist, may place the patient at an unacceptably increased risk with study drug
Show all 9Show fewer
  • History of any of the following: sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, atrial fibrillation, cardiac arrest, Mobitz II second degree heart block, or third degree heart block - QTc at Screening > 450 ms in males / > 470 ms in females
  • Family history of short QT syndrome, long QT syndrome
  • Obligate use of a cardiac pacemaker - Use of medications that may cause Torsades de Pointes

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Study site

    Lille

  • Study site

    Nantes

  • Study site

    Tours

Other trials in France

About this study

Official title: A Phase 1b Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Subjects With Relapsed Multiple Myeloma

The purpose of this study is to evaluate the safety and tolerability and to establish the maximum tolerated dose of JNJ-26481585 combined with VELCADE and dexamethasone.

Read the detailed description

This is an open-label (patient and study personnel will know what treatment is being administered), multicenter, dose escalation study. Increasing doses of JNJ-26481585 will be explored in combination with the standard VELCADE/dexamethasone dose. After the maximum tolerated dose (MTD) is determined, up to 24 patients will be entered in a treatment group to receive the MTD (and if deemed necessary a lower dose level) to further assess the safety and activity of this combination. There will be 3 phases in the study: a Screening Phase (from signing of informed consent until immediately before dosing), an open-label Treatment Phase (from the first dose of JNJ-26481585 and VELCADE-dexamethasone until the End of Treatment Visit), and a Posttreatment/Follow-up Phase. Patients who achieve a positive response to treatment at the end of Cycle 1 will continue to receive JNJ-26481585 and VELCADE-dexamethasone for a maximum of 11 cycles (eight 3-week treatment cycles, followed by three 5-week treatment cycles). Patients with progressive disease (PD) or unacceptable toxicity will be withdrawn from treatment. In the Follow-Up Phase, patients whose disease has not progressed or who discontinued treatment for reasons other than PD will be assessed approximately every 6 weeks until PD is recorded or until the start of subsequent therapy. The study will end when all patients have been assessed with PD, or 12 months after the last patient is enrolled, whichever is earlier. Patient safety will be monitored. Drug A, JNJ-26481585, will be taken orally on Days 1, 3, and 5 of each week at doses starting at 6 mg and escalating to 12 mg. Drug B, VELCADE, will be given by subcutaneous injection (under the skin) at a dose of 1.3 mg/m2 on Days 1, 4, 8, and 11 of each 21-day cycle (Cycles 1 to 8) and on Days 1, 8, 15, and 22 of each 35-day cycle (Cycles 9-11). Drug C, dexamethasone, will be taken orally on the day of and after VELCADE at a dose of 20 mg. Dosing may be adjusted, based on tolerability.

Being tested
JNJ-2641585 / VELCADE / Dexamethasone
Keywords
Multiple myeloma that has relapsed or is progressive following prior therapy, Relapsed Multiple Myeloma, JNJ 26481585, VELCADE, Bortezomib, Dexamethasone
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-2641585 / VELCADE / DexamethasoneDrug

    JNJ-26481585: type=range, unit=mg, number=6 to 12, form=capsules, route=oral use, on Days 1, 3, and 5 of each week. VELCADE: type=exact, unit=mg/m2, number=1.3, form=powder for solution for injection, route=subcutaneous use, on Days 1, 4, 8, and 11 of each 21-day cycle (Cycles 1 to 8) and on Days 1, 8, 15, and 22 of each 35-day cycle (Cycles 9-11). Dexamethasone: type=exact, unit=mg, number=20, form=tablets, route=oral use, on the day of and after VELCADE.

Study groups in NCT01464112
Study groupRoleWhat they receive
001ExperimentalNot described
Receives: Drug: JNJ-2641585 / VELCADE / Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the dose-limiting toxicity and set the MTD for the combination of JNJ-26481585 and VELCADE-dexamethasone

    Based on the safety analysis of all cohorts using the patients-treated population

    Measured: Maximum of 18 months

Secondary outcomes (14)

  1. Adverse events

    As a measure of safety

    Measured: Maximum of 18 months

  2. Clinical laboratory tests

    As a measure of safety

    Measured: Maximum of 18 months

  3. Overall response rate

    Measured: Maximum of 18 months

  4. Duration of response

    Measured: Maximum of 18 months

  5. Profile of pharmacokinetics evaluations for JNJ-26481585

    Cmax, Area Under Curve, Tmax

    Measured: Maximum of 18 months

  6. Profile of pharmacokinetics evaluations for VELCADE

    Cmax, Area Under Curve, Tmax

    Measured: Maximum of 18 months

  7. Bone cell morphology

    Measured: Maximum of 18 months

  8. Pulse

    Measured: Maximum of 18 months

  9. Heart rate

    Measured: Maximum of 18 months

  10. Blood pressure

    Measured: Maximum of 18 months

  11. Body temperature

    Measured: Maximum of 18 months

  12. Height

    Measured: Maximum of 18 months

  13. Weight

    Measured: Maximum of 18 months

  14. Body surface area

    Measured: Maximum of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2011 (estimated)
  2. Study start16 Sep 2011
  3. Primary completion19 Nov 2013
  4. Study completion19 Nov 2013

Resources

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
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01464112
Sponsor's protocol ID
CR018661
Other IDs
26481585MMY1001, 2011-001001-27
Status last verified
Jan 2020
First submitted
30 Aug 2011
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes

Publications

  • Moreau P, Facon T, Touzeau C, Benboubker L, Delain M, Badamo-Dotzis J, Phelps C, Doty C, Smit H, Fourneau N, Forslund A, Hellemans P, Leleu X. Quisinostat, bortezomib, and dexamethasone combination therapy for relapsed multiple myeloma. Leuk Lymphoma. 2016 Jul;57(7):1546-59. doi: 10.3109/10428194.2015.1117611. Epub 2016 Jan 12.

    PubMed 26758913

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-2641585 / VELCADE / Dexamethasone in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 3 sites in France.

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 9 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 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. 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?

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?

Determine the dose-limiting toxicity and set the MTD for the combination of JNJ-26481585 and VELCADE-dexamethasone (time frame: Maximum of 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01464112, which also lists 1 linked publication.

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 22 Jan 2020.

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