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Multiple MyelomaPhase 1NCT01497093

Study to Determine the Maximum Tolerated Dose for the Combination of Pomalidomide, Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

A Phase 1 study testing Pomalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Celgene at 6 sites in United States.

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 maximum tolerated dose (MTD) of pomalidomide in combination with bortezomib and low-dose dexamethasone in subjects with relapsed or refractory multiple myeloma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Pomalidomide, Bortezomib and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
6 sitesUnited States
Study dates
15 Feb 2012to 23 Jul 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be ≥ 18 years at the time of signing the informed consent form.
  • Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours).
  • Subjects must have had at least 1 but no greater than 4 prior anti-myeloma therapies.
  • Subjects must have received at least 2 consecutive cycles of prior treatment with lenalidomide and must be refractory to their last lenalidomide-containing regimen (either as a single agent or in combination).
  • Subjects must have received at least 2 consecutive cycles of prior treatment with a proteasome inhibitor-containing regimen, but must not be refractory to bortezomib (either as a single agent or in combination).
  • Subjects must have documented progression during or after their last anti-myeloma therapy.
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.

Who cannot join

  • Subjects who are refractory to bortezomib either as single agent or in combination.
  • Subjects with peripheral neuropathy ≥ Grade 2
  • Subjects with non-secretory multiple myeloma
  • Subjects with any of the following laboratory abnormalities:
  • Absolute neutrophil count (ANC) < 1,000/µL
  • Platelet count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/ µL for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells
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  • 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 Transaminase, serum glutamic pyruvic (SGPT)/ alanine aminotransferase (ALT) > 3.0 x upper limit of normal (ULN)
  • Serum total bilirubin > 1.5 x ULN
  • Subjects with prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years. Except the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative.
  • Subjects with previous therapy with Pomalidomide
  • Subjects with hypersensitivity to thalidomide, lenalidomide, bortezomib, boron, mannitol, or dexamethasone
  • Subjects with ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy
  • Subjects who had 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, Any anti-myeloma drug therapy
  • Subjects who have received any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
  • Pregnant or breastfeeding females
  • Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception.
  • Subjects with known Human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B, or C

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115-6084

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

Other trials in United States

About this study

Official title: A Phase 1, Multicenter, Open Label, Dose-escalation Study to Determine the Maximum Tolerated Dose for the Combination of Pomalidomide (POM), Bortezomib (BTZ) and Low-Dose Dexamethasone (LDDEX) in Subjects With Relapsed or Refractory Multiple Myeloma (MM)

The purpose of this study is to determine the maximum tolerated dose (MTD) of pomalidomide in combination with bortezomib and low-dose dexamethasone in subjects with relapsed or refractory multiple myeloma

Read the detailed description

A 3 + 3 design will be utilized to determine the MTD for POM + IV BTZ + LD-DEX combination treatment in a 21-day treatment cycle. DLT will be assessed to determine MTD during the first treatment cycle. Once the MTD is determined or the maximum planned dose (MPD) is reached without reaching MTD for POM + IV BTZ + LD-DEX, a cohort of 6 additional subjects will be treated at this MTD/MPD level to further confirm the safety and assess preliminary efficacy. An additional cohort of subjects will be enrolled to explore the safety for the combination of POM + BTZ + LD-DEX when using SQ BTZ. Subject in this cohort will receive POM + BTZ + LD-DEX at the MTD/MPD level per the MTD determination part of the study, except, the BTZ will be administered subcutaneously (SQ) instead of intravenously (IV). In, Protocol Amendment #4, the number of subject enrolled to be enrolled into the exploratory SQ BTZ cohort was increased from 6 to 12.

Keywords
Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Relapsed and Refractory Multiple Myeloma, Refractory Myeloma, Resistant Multiple Myeloma, Treatment-resistant Multiple Myeloma, Pomalidomide, Lenalidomide-resistant
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell, Recurrence

What participants receive

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

  • PomalidomideDrug

    Also called CC-4047, Oral Pomalidomide

    Pomalidomide 1, 2, 3, or 4 mg will be taken orally on Days 1-14 of a 21-day cycle

  • BortezomibDrug

    Also called Velcade

    Bortezomib 1 or 1.3 mg/m2 will be administered intravenously or subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression

  • DexamethasoneDrug

    Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old] will be taken orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression

Study groups in NCT01497093
Study groupRoleWhat they receive
Pomalidomide/Bortezomib/DexamethasoneExperimental1, 2, 3 or 4 mg of pomalidomide will be taken orally on Days 1-14 of a 21-day cycle along with 1 or 1.3 mg/m2 of bortezomib administered intravenously or subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression, and dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression
Receives: Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone

What is being measured

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

  1. Maximum Tolerated Dose

    To determine the maximum tolerated dose (MTD)

    Measured: Up to 2 years

Secondary outcomes (5)

  1. Adverse events

    Number of participants with adverse events (AEs)

    Measured: Up to 7 years

  2. Overall Survival

    Number of patients alive

    Measured: Up to 7 years

  3. Response Rate

    Overall response rate based on the International Myeloma Working Group (IMWG) Uniform response criteria

    Measured: Up to 7 years

  4. Duration of response

    Time from the initial documented response to confirmed disease progression

    Measured: Up to 7 years

  5. Time to response

    Time from enrollment to the first documented response

    Measured: Up to 7 years

Timeline

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

  1. First posted22 Dec 2011 (estimated)
  2. Study start15 Feb 2012
  3. Primary completion23 Jul 2019
  4. Study completion23 Jul 2019

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01497093
Sponsor's protocol ID
CC-4047-MM-005
Status last verified
Apr 2020
First submitted
20 Dec 2011
Last updated
7 Apr 2020
Results posted
No
Data monitoring committee
No

Publications

  • Richardson PG, Hofmeister CC, Raje NS, Siegel DS, Lonial S, Laubach J, Efebera YA, Vesole DH, Nooka AK, Rosenblatt J, Doss D, Zaki MH, Bensmaine A, Herring J, Li Y, Watkins L, Chen MS, Anderson KC. Pomalidomide, bortezomib and low-dose dexamethasone in lenalidomide-refractory and proteasome inhibitor-exposed myeloma. Leukemia. 2017 Dec;31(12):2695-2701. doi: 10.1038/leu.2017.173. Epub 2017 Jun 2.

    PubMed 28642620

  • Pelligra CG, Parikh K, Guo S, Chandler C, Mouro J, Abouzaid S, Ailawadhi S. Cost-effectiveness of Pomalidomide, Carfilzomib, and Daratumumab for the Treatment of Patients with Heavily Pretreated Relapsed-refractory Multiple Myeloma in the United States. Clin Ther. 2017 Oct;39(10):1986-2005.e5. doi: 10.1016/j.clinthera.2017.08.010. Epub 2017 Sep 28.

    PubMed 28967482

  • Moreau P, Dimopoulos MA, Richardson PG, Siegel DS, Cavo M, Corradini P, Weisel K, Delforge M, O'Gorman P, Song K, Chen C, Bahlis N, Oriol A, Hansson M, Kaiser M, Anttila P, Raymakers R, Joao C, Cook G, Sternas L, Biyukov T, Slaughter A, Hong K, Herring J, Yu X, Zaki M, San-Miguel J. Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.

    PubMed 28504846

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pomalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Celgene at 6 sites in United States.

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 7 inclusion and 20 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 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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?

Maximum Tolerated Dose (time frame: Up to 2 years). 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 NCT01497093, which also lists 3 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 7 Apr 2020.

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