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Multiple Myeloma in RelapsePhase 2NCT02176213

Study of Pomalidomide, Cyclophosphamide, Dexamethasone in Relapsed/Refractory Multiple Myeloma

A Phase 2 study testing Pomalidomide, Cyclophosphamide and Dexamethasone in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Ajai Chari 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
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Trial summary

This study is being done to learn more about the drug, pomalidomide and to gather data on its safety and side effects when used in combination with commercially available cyclophosphamide and dexamethasone. This combination is considered experimental and has not been approved by the FDA. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pomalidomide, Cyclophosphamide and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Jun 2014to 7 May 2019
Phase
Phase 2
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

  • Disease related:
  • Patients must have a history of symptomatic multiple myeloma according to the IMWG criteria
  • Patients must have received at least two prior lines of therapy and also must be refractory to lenalidomide.
  • Patient has relapsed or relapsed/refractory MM.
  • Patients must currently have measurable disease, as defined as:
  • Serum M-protein ≥ 0.5 g/dL
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  • Urine M-protein ≥ 200 mg/24 hours
  • Serum free light chain assay: involved FLC level ≥ 10 mg/dl provided serum FLC ratio is abnormal
  • If no monoclonal protein is detected, then > 30% monoclonal bone marrow plasma cells
  • Demographic:
  • Male or female adults ≥ 18 years old
  • Able to sign informed consent and to comply with the protocol
  • Life expectancy > 12 weeks
  • ECOG performance status ≤ 2
  • All study participants must be registered into the mandatory POMALYST REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program.
  • Laboratory
  • ANC ≥ 1000/µL
  • Platelets ≥ 50,000/µL (Patients with plasma cells 50% of bone marrow nucleated cells, and platelets ≥ 30,000/µL will be permitted regardless of the baseline ANC)
  • Cr < 3
  • AST ≤ 2.5 x ULN
  • ALT ≤ 2.5 x ULN
  • Serum Bilirubin ≤ 1.5 x ULN (except patients with Gilbert's syndrome who must have a total bilirubin of <3 time ULN)
  • Other
  • Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control at least 28 days before taking pomalidomide.

Who cannot join

  • Previous treatment with pomalidomide
  • Patients who received chemotherapy or radiation therapy to 30% of marrow-bearing bone within ≤ 2 weeks or experimental agent/therapy within 4 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies
  • Known hypersensitivity to thalidomide or lenalidomide
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or similar drugs
  • Other concurrent severe and/or uncontrolled medical conditions including abnormal laboratory values that could cause unacceptable safety risks or compromise compliance with the protocol
  • Patients for whom prophylactic anticoagulation therapy is not an option unless due to thrombocytopenia
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  • Patients who received allogenic stem cell transplantation < 12 months prior to entering the study or show evidence of active graft-versus-host disease that requires immunosuppressive therapy
  • Patients with existing peripheral neuropathy grade > 2
  • Patients with an active malignancy requiring treatment in the next 12 months (except for basal or squamous cell carcinoma, or in situ cancer of the cervix or breast, and asymptomatic prostate cancer)
  • Patients with known positivity for HIV or active hepatitis B or C
  • Corticosteroid therapies of > 20 mg/day prednisone, > 4 mg/day dexamethasone, > 80 mg/day hydrocortisone, or equivalent. Oral, inhaled, or topical steroids are allowed during study as long as it does not exceed 80 mg/day hydrocortisone.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: A Phase II Study of Pomalidomide, Daily Low Dose Oral Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma

This study is being done to learn more about the drug, pomalidomide and to gather data on its safety and side effects when used in combination with commercially available cyclophosphamide and dexamethasone. This combination is considered experimental and has not been approved by the FDA.

Pomalidomide is a third generation immunomodulatory (IMiDs) agent, which is a more potent version of thalidomide and lenalidomide drugs that have been approved by the United States Food and Drug Administration [FDA] for the treatment of MM. In February 2013, pomalidomide was also approved by the FDA for patients with MM who have had more than 2 types of therapy.

Pomalidomide is taken orally as capsules, and cyclophosphamide and dexamethasone are also taken orally as tablets in this study. Cyclophosphamide and dexamethasone are commercially available and are often used in combination with other drugs to treat Multiple Myeloma. Preliminary data from both the laboratory and patient studies suggest that this combination of drugs is more effective than pomalidomide and dexamethasone alone. However, the regimen being used in this study, which consists of daily cyclophosphamide, also permits support of low blood counts with either injections or transfusions as needed.

Read the detailed description

This is an open label, single center, phase II study of a combination of pomalidomide, daily low dose oral cyclophosphamide, and dexamethasone in patients with relapsed/refractory multiple myeloma. The three oral drugs will be given in 28-day cycles: Pomalidomide 4 mg daily x 21 days; cyclophosphamide 50 mg BID x 21 days; and dexamethasone 40 mg weekly x 3 (20 mg weekly if the patient aged ≥ 75 years old). Subjects meeting eligibility criteria with ANC < 1000/µL and platelet count < 50,000/µL will start at dose level -1 of both pomalidomide (3 mg daily) and cyclophosphamide (50 mg daily). G-CSF and platelet transfusion support is permitted if needed.

Dose reduction for hematologic toxicity will begin with cyclophosphamide and then subsequently alternate with pomalidomide until a subject cannot tolerate dose level -2 of both agents - in which case subject would come off study. If subject has 2 or more concurrent toxicities that are potentially attributable to both agents (e.g. hematologic toxicity) then dose modification guidelines will be followed with dose reduction being done sequentially with one agent at a time, unless in the opinion of the investigator, both agents required concurrent dose reduction.

Keywords
Relapsed, Refractory, Multiple Myeloma, Pomalidomide, Cyclophosphamide, Dexamethasone
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

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

  • PomalidomideDrug

    Also called pomalyst

    4 mg PO x 21 days

  • CyclophosphamideDrug

    Also called cytoxan

    low dose cyclophosphamide 50 mg PO BID x 21 days

  • DexamethasoneDrug

    dexamethasone 40 mg PO weekly (or 20 mg if ≥ 75 years old).

Study groups in NCT02176213
Study groupRoleWhat they receive
Pomalidomide, Cyclophosphamide, DexamethasoneExperimentalThree oral drugs will be given in 28-day cycles: Pomalidomide 4 mg daily x 21 days; cyclophosphamide 50 mg BID x 21 days; and dexamethasone 40 mg weekly x 3 (20 mg weekly if the patient aged ≥ 75 years old)
Receives: Drug: Pomalidomide; Drug: Cyclophosphamide; Drug: Dexamethasone

What is being measured

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

  1. Best overall response rate (ORR)

    disease response

    Measured: up to 24 months

Secondary outcomes (9)

  1. Stringent complete response (sCR)

    Measured: up to 24 months

  2. Complete response (CR)

    Measured: up to 24 months

  3. Very good partial response (VGPR)

    Measured: up to 24 months

  4. Partial response (PR)

    Measured: up to 24 months

  5. Time to progression (TTP)

    TTP is defined as beginning with the time the first dose of PCD regimen is administered until disease progression on PCD regimen.

    Measured: up to 24 months

  6. Duration of response (DOR)

    DOR is defined as the time from first evidence of PR or better to confirmation of disease progression.

    Measured: up to 24 months

  7. Clinical benefit response (CBR)

    CBR is the combination of the ORR and minimal response (MR) i.e. this includes sCR, CR, VGPR, PR, and MR.

    Measured: up to 24 months

  8. Progression free survival (PFS)

    PFS is defined as the duration of time from start of treatment to the first occurrence of disease progression or death on study from any cause, whichever occurs earlier.

    Measured: up to 24 months

  9. Overall survival (OS)

    OS is defined as the time from the first dose of study treatment to the date of death (whatever the cause).

    Measured: up to 24 months

Timeline

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

  1. First posted27 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completion7 May 2019
  4. Study completion7 May 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02176213
Sponsor's protocol ID
GCO 14-0825
Other IDs
PO-CL-MM-PI-002404
Status last verified
Jun 2019
First submitted
25 Jun 2014
Last updated
18 Jun 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pomalidomide, Cyclophosphamide and Dexamethasone in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Ajai Chari 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 24 inclusion and 11 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 18 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?

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?

Best overall response rate (ORR) (time frame: up to 24 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 NCT02176213.

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 18 Jun 2019.

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