AzTrials
AzTrials

Multiple MyelomaPhase 2NCT01159574

Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma

A Phase 2 study testing dexamethasone, clarithromycin and Pomalidomide in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

This study is intended to investigate the combination of the combination of dexamethasone (Decadron®), Clarithromycin (Biaxin®), and pomalidomide (CC-4047®) [ClaPd] in multiple myeloma patients who have relapsed or refractory disease who have failed prior treatment with lenalidomide when used alone or in combination… 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?
dexamethasone, clarithromycin and Pomalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteUnited States
Study dates
Aug 2010to 5 May 2015
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must voluntarily sign and understand written informed consent.
  • Age > 18 years at the time of signing the consent form.
  • Histologically confirmed MM
  • Relapsed or refractory myeloma, progression of disease either after prior therapy or lack of response to currently used therapy.
  • Relapsed or progressive disease after at least 3 prior therapeutic treatments or regimens for multiple myeloma.
  • Must have been previously treated with lenalidomide and has been determined to be refractory, resistant, or relapsed.
Show all 13Show fewer
  • Measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
  • Karnofsky performance status ≥70% (>60% if due to bony involvement of myeloma
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and thalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy. See Appendix V: Pomalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. †A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). †
  • 1ife expectancy ≥ 3 months
  • Subjects must meet the following laboratory parameters:
  • Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Platelets count ≥ 50,000/mm3 (75 x 109/L) Serum SGOT/AST ≤ 2.0 x upper limits of normal Serum SGPT/ALT <3.0 x upper limits of normal (ULN) Serum creatinine ≤ 2.5 x upper limits of normal Serum total bilirubin ≤ 1.5 x upper limits of normal

Who cannot join

  • Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine).
  • Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 5 years.
  • Myocardial infarction within 6 months prior to enrollment, or NYHA(New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Known HIV infection
  • Known hepatitis B or hepatitis C infection.
  • Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
Show all 17Show fewer
  • Any coexisting medical problem or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial.
  • Known hypersensitivity to thalidomide or lenalidomide.
  • History of thromboembolic event within the past 6 months prior to enrollment.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or breast feeding females.
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Use of any other experimental drug or therapy within 14 days of baseline.
  • Known hypersensitivity to thalidomide or lenalidomide.
  • The development of erythema nodorum if characterized by a desquamating rash while taking thalidomide, CC-4047 or similar drugs.
  • Any prior use of CC-4047.
  • Concurrent use of other anti-cancer agents or treatments.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Cornell Medical College

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase II Study of Dexamethasone (DECADRON®), Clarithromycin (BIAXIN®), and Pomalidomide (CC-4047®) for Subjects With Relapsed or Refractory Multiple Myeloma

This study is intended to investigate the combination of the combination of dexamethasone (Decadron®), Clarithromycin (Biaxin®), and pomalidomide (CC-4047®) [ClaPd] in multiple myeloma patients who have relapsed or refractory disease who have failed prior treatment with lenalidomide when used alone or in combination with corticosteroids. Primary endpoint will be response rate to treatment. Secondary endpoints will include toxicity of the combination, time to maximum response, and time to disease progression

Read the detailed description

This phase II study is a treatment program for patients with relapsed or refractory multiple myeloma who have had prior treatment with lenalidomide. Up to 54 patients will be enrolled. Patients who sign informed consent form and fulfill all eligibility criteria will be enrolled.

ClaPd therapy:

Dexamethasone (40mg ) on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.

Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle.

Serial clinic visits and laboratory measurements will be performed to monitor for treatment response. Those patients who demonstrate progression of disease at any point during ClaPd therapy will be taken off study.

At the end of every cycle (which may coincide with day 1 of the new cycle), response and toxicity will be evaluated. During cycle 1, patients will have labwork done weekly (CBC with differential and blood electrolytes). All patients will remain on study until disease progression or side effects become excessive. Patients who achieve a stable plateau may be taken off study if eligible to proceed to high dose chemotherapy and autologous stem cell transplantation.

Medical subject headings
Multiple Myeloma

What participants receive

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

  • dexamethasoneDrug

    Also called Decadron

    40mg will be given on days 1, 8, 15, 22 of a 28-day cycle

  • clarithromycinDrug

    Also called Biaxin

    orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle

  • PomalidomideDrug

    Also called CC-4047

    orally 4mg daily for days 1-21 of each 28 day cycle

Study groups in NCT01159574
Study groupRoleWhat they receive
all patientsExperimentalClaPd therapy: Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle. Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
Receives: Drug: dexamethasone; Drug: clarithromycin; Drug: Pomalidomide

What is being measured

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

  1. Overall Response Rate

    Best response rate was recorded for all patients, using the IMWG criteria.

    Measured: from baseline to cycle with maximum response, which was achieved on average after 2 cycles

Secondary outcomes (2)

  1. Time to Maximum Response, Expressed as Number of Cycles of Treatment to Maximum Response

    Measured: From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days

  2. Time to Disease Progression (Progression Free Survival)

    Measured: From start of treatment, to date of disease progression

Timeline

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

  1. First posted9 Jul 2010 (estimated)
  2. Study startAug 2010
  3. Primary completion5 May 2015
  4. Study completion5 May 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01159574
Sponsor's protocol ID
1004011012
Other IDs
PO-MM-PI-0023
Status last verified
May 2019
First submitted
16 Jun 2010
Last updated
11 Jun 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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 2 study testing dexamethasone, clarithromycin and Pomalidomide in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 1 site 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 13 inclusion and 17 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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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?

Yes. Results are posted in the registry (first posted 12 Apr 2017). 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?

Overall Response Rate (time frame: from baseline to cycle with maximum response, which was achieved on average after 2 cycles). 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 NCT01159574, 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 11 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in