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Multiple MyelomaPhase 1NCT01568294

Japanese Phase 1 Study to Evaluate Tolerated Dose, Safety, and Efficacy of Pomalidomide in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

A Phase 1 study testing pomalidomide in people with Multiple Myeloma, run by Celgene at 8 sites in Japan.

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 determine the tolerated dose of pomalidomide and also to evaluate the pharmacokinetics, safety and efficacy of pomalidomide in patients with refractory or relapsed and refractory multiple myeloma. 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?
pomalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
8 sitesJapan
Study dates
1 Apr 2012to 8 Jul 2015
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be ≥ 20 years of age at the time of signing the informed consent document
  • The subject must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Subjects must have documented diagnosis of multiple myeloma and have measurable disease
  • All subjects must have had at least 2 prior lines of anti-myeloma therapy. Induction therapy followed by stem cell transplant and consolidation/maintenance will be considered as one line
  • All subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last anti-myeloma therapy.
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  • Primary refractory: Subjects who have never achieved any response better than progressive disease (PD) to any previous line of anti-myeloma therapy.
  • Relapsed and refractory: Subjects who have relapsed after having achieved at least stable disease (SD) to at least one prior regimen and then developed progressive disease (PD) on or within 60 days of completing their last anti-myeloma therapy.
  • Subjects must have also undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen).
  • All subjects must have received adequate prior alkylator therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.

Who cannot join

  • Pregnant or breastfeeding females
  • Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
  • ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy
  • Patients unable or unwilling to undergo antithrombotic prophylactic treatment will not be eligible to participate in this study
  • Any of the following laboratory abnormalities:
  • Absolute neutrophil count (ANC) < 1,000/µL
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  • Platelet count < 75,000/µL for patients in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/µL for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells
  • Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula
  • Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
  • Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted)
  • Serum glutamic oxaloacetic transaminase (SGOT) /aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT) /alanine aminotransferase (ALT) > 3.0 x upper limit of normal (ULN)
  • Serum total bilirubin > 2.0 mg/dL (34.2 μmol/L); or ≥ 3.0 x upper limit of normal (ULN) for subjects with hereditary benign hyperbilirubinaemia
  • Peripheral neuropathy ≥ Grade 2
  • Patients who received any of the following within the last 14 days of initiation of study treatment:
  • Plasmapheresis
  • Major surgery (kyphoplasty is not considered major surgery)
  • Radiation therapy
  • Use of any anti-myeloma drug therapy

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Japan8 sites

  • Kyusyu University Hospital

    Fukuoka, 812-8582

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193

  • Kameda General Hospital

    Kamogawa, 296-1602

  • Saitama Medical Center, Saitama Medical University

    Kawagoe, Saitama, 350-8550

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama Medical Center

    Okayama, 701-1192

  • National Cancer Center Hospital

    Tyuuou, Tokyo, 104-0045

Other trials in Japan

About this study

Official title: A Phase 1, Multicenter, Open-label, Dose-escalation Study in Japan to Determine the Tolerated Dose and to Evaluate the Safety, Efficacy, and Pharmacokinetics of Pomalidomide Alone or in Combination With Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

The purpose of this study is to determine the tolerated dose of pomalidomide and also to evaluate the pharmacokinetics, safety and efficacy of pomalidomide in patients with refractory or relapsed and refractory multiple myeloma.

Being tested
pomalidomide
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pomalidomideDrug

    2 mg or 4mg oral pomalidomide once per day on Days 1-21 of a 28-day cycle

Study groups in NCT01568294
Study groupRoleWhat they receive
pomalidomideExperimentalPatients will receive pomalidomide orally on Days 1-21 of each 28-day cycle until when/if a discontinuation criterion, e.g., disease progression, development of an unacceptable toxicity, voluntary withdrawal, or pomalidomide is in market for the target indication.
Receives: Drug: pomalidomide

What is being measured

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

  1. Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events

    Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events

    Measured: Up to 28 Days

Secondary outcomes (11)

  1. Maximum observed plasma concentration (Cmax)

    Maximum observed plasma concentration (Cmax)

    Measured: Up to 28 days

  2. Time to maximum observed plasma concentration (tmax)

    Time to maximum observed plasma concentration (tmax)

    Measured: Up 28 days

  3. Area under the plasma concentration-time curve (AUC0-t)

    Area under the plasma concentration-time curve (AUC0-t)

    Measured: Up to 28 days

  4. Apparent total plasma clearance (CL/F)

    Apparent total plasma clearance (CL/F)

    Measured: Up to 28 days

  5. Apparent total volume of distribution (Vz/F)

    Apparent total volume of distribution (Vz/F)

    Measured: Up to 28 days

  6. Estimate of the terminal elimination half-life in plasma (t1/2)

    Estimate of the terminal elimination half-life in plasma (t1/2)

    Measured: Up to 28 days

  7. Safety (the number of participants with adverse events, incidence, severity, causality)

    Safety (the number of participants with adverse events, incidence, severity, causality)

    Measured: Up to 2 years

  8. Progression-free survival

    Progression-free survival

    Measured: Up to 28 days

  9. Myeloma response

    Myeloma response

    Measured: Up to 28 days

  10. Time to Response

    Time to Response

    Measured: Up to 28 days

  11. Duration of Response

    Duration of Response

    Measured: Up to 28 days

Timeline

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

  1. First posted2 Apr 2012 (estimated)
  2. Study start1 Apr 2012
  3. Primary completion8 Jul 2015
  4. Study completion8 Jul 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01568294
Sponsor's protocol ID
CC-4047-MM-004
Status last verified
Nov 2019
First submitted
29 Mar 2012
Last updated
12 Nov 2019
Results posted
No
Data monitoring committee
No

Publications

  • Matsue K, Iwasaki H, Chou T, Tobinai K, Sunami K, Ogawa Y, Kurihara M, Midorikawa S, Zaki M, Doerr T, Iida S. Pomalidomide alone or in combination with dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma. Cancer Sci. 2015 Nov;106(11):1561-7. doi: 10.1111/cas.12772. Epub 2015 Nov 4.

    PubMed 26292221

  • Mark TM, Forsberg PA, Rossi AC, Pearse RN, Pekle KA, Perry A, Boyer A, Tegnestam L, Jayabalan D, Coleman M, Niesvizky R. Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. Blood Adv. 2019 Feb 26;3(4):603-611. doi: 10.1182/bloodadvances.2018028027.

    PubMed 30792190

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pomalidomide in people with Multiple Myeloma, run by Celgene at 8 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 11 inclusion and 18 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 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

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?

Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events (time frame: Up to 28 Days). 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 NCT01568294, which also lists 2 linked publications.

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 12 Nov 2019.

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