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Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00558896

CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis

A Phase 2 study testing dexamethasone and pomalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 3 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

RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with dexamethasone may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
dexamethasone and pomalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
378 participants
Where
3 sitesUnited States
Study dates
Nov 2007to 25 Oct 2017
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Symptomatic multiple myeloma
  • Previously treated disease meeting one of the following criteria:
  • Have light-chain amyloidosis that has been treated with at least one prior regimen
  • Symptomatic (relapsed or refractory) multiple myeloma
  • Patients must have received 1-3 treatment regimens
  • Induction therapy followed by autologous stem cell transplantation and consolidation considered one regimen
  • Measurable disease, as defined by 1 of the following:
  • Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
  • More than 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
  • Serum immunoglobulin free light chain (FLC) > 10 mg/dL and an abnormal FLC ratio
  • Measurable soft tissue plasmacytoma, not previously irradiated
  • More than 30% plasma cells in bone marrow
  • At least 10% plasma cells as measured by bone marrow aspirate, bone marrow biopsy, or labeling index
  • No monoclonal gammopathy of undetermined significance (not applicable for patients with amyloid)
  • No smoldering myeloma (not applicable for patients with amyloid)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0, 1, or 2
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 75,000/μL
  • Creatinine ≤ 2.5 mg/dL
  • Not pregnant or nursing
  • Women must refrain from breastfeeding during study participation and for at least 28 days after discontinuation of study drug
  • Negative pregnancy test
  • Fertile female patients must use two reliable forms of contraception simultaneously at least 28 days before beginning, during, and at least 28 days after completion of study drug
  • The two methods of reliable contraception must include one highly effective method (i.e., intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, or partner's vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, or cervical cap)
  • Fertile male patients must use a latex condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment
  • Men must agree to abstain from donating semen or sperm during study participation and for 28 days after discontinuation of study drug
  • Willing to abstain from donating blood during study participation and for 28 days after discontinuation of study drug
  • No uncontrolled infection
  • No other active malignancy
  • No New York Heart Association class III or IV cardiac disease (all patients)
  • Serum troponin T > 0.10 ng/mL (amyloid patients only)
  • No known positivity for HIV or active hepatitis infection
  • No active deep vein thrombosis or pulmonary embolism that has not been therapeutically anticoagulated
  • No condition, including the presence of laboratory abnormalities, that places the patient at unacceptable risk for participating in the study or confounds the ability to interpret data from the study
  • No known hypersensitivity to thalidomide or lenalidomide including development of erythema nodosum if characterized by a desquamating rash
  • No peripheral neuropathy > grade 2

PRIOR CONCURRENT THERAPY:

  • All previous cancer therapy, including chemotherapy and investigational agents, must have been discontinued ≥ 2 weeks prior to study registration
  • No radiotherapy ≤ 14 days prior to study registration
  • No other concurrent anti-myeloma therapy
  • No concurrent radiotherapy, except for palliation of a single painful bone lesion or fracture
  • Routine concurrent bisphosphonate therapy allowed for patients with myeloma bone disease
  • Willing and able to take aspirin or alternate prophylactic anticoagulation

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259-5499

Other trials in United States

About this study

Official title: A Phase II Trial of CC-4047 Plus Dexamethasone in Patients With Relapsed of Refractory Multiple Myeloma or Amyloidosis

RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with dexamethasone may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.

Read the detailed description

OBJECTIVES:

  • To assess the response rate and duration of remission with low-dose CC-4047 plus dexamethasone in patients with relapsed or refractory multiple myeloma or amyloidosis.
  • To assess the toxicity of CC-4047 plus dexamethasone in this patient population.
  • To assess in an expansion cohort the response rate with an increase in CC-4047 dose among patients who fail to respond adequately to the initial starting dose following the first 2 courses of treatment.
  • To assess the response rate and duration of remission with CC-4047 plus dexamethasone in patients with lenalidomide resistant or refractory multiple myeloma.
  • To assess the response rate and duration of remission with CC-4047 plus dexamethasone in patients with previously treated light chain amyloidosis.
  • To assess the response rate and duration of remission with low- and high-dose CC-4047 plus dexamethasone in patients with lenalidomide and bortezomib refractory multiple myeloma.
  • To assess the response rate and duration of remission with high-dose CC-4047 plus dexamethasone in patients with relapsed or refractory myeloma who received ≤ 3 treatment regimens.

OUTLINE: Patients are grouped according to disease status (relapsed/refractory myeloma [closed to accrual as of 8/5/2008] vs lenalidomide resistant/refractory myeloma [closed to accrual as of 4/2/2009] vs previously treated light chain amyloidosis vs lenalidomide and bortezomib resistant/refractory myeloma {low-dose/day}[closed to accrual as of 11/20/09] vs lenalidomide and bortezomib resistant/refractory myeloma (high-dose/day) vs relapsed/refractory myeloma {high-dose/day}).

Patients receive oral CC-4047 on days 1-28 and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks and then at 6 months.

Keywords
stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

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

  • dexamethasoneDrug

    40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.

  • pomalidomideDrug

    Also called CC-4047

    2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).

Study groups in NCT00558896
Study groupRoleWhat they receive
Relapsed Myeloma (<4 Prior Regimens)ExperimentalPomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
Receives: Drug: dexamethasone; Drug: pomalidomide
Lenalidomide Refractory MyelomaExperimentalPomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
Receives: Drug: dexamethasone; Drug: pomalidomide
Bortezomib/Lenalidomide Refractory/Relapsed MyelomaExperimentalPomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
Receives: Drug: dexamethasone; Drug: pomalidomide
Bortezomib/Lenalidomide Relapsed/Refractory MyelomaExperimentalPomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
Receives: Drug: dexamethasone; Drug: pomalidomide
Relapsed Myeloma (< 4 Prior Regimens)ExperimentalPomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
Receives: Drug: dexamethasone; Drug: pomalidomide
Relapsed/Refractory MyelomaExperimentalPomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
Receives: Drug: dexamethasone; Drug: pomalidomide
Relapsed AmyloidosisExperimentalPomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
Receives: Drug: dexamethasone; Drug: pomalidomide

What is being measured

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

  1. The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)

    Response that was confirmed on 2 consecutive evaluations

    • Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.
    • Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow.
    • Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels.

    Measured: Duration of study (up to 3 years)

Secondary outcomes (2)

  1. Progression Free Survival (PFS)

    PFS was defined as the time from registration to progression or death due to any cause. PFS was analyzed using Kaplan Meier method.

    Progression was defined as any one or more of the following:

    • 25% increase in serum M-component (absolute increase >= 0.5g/dl)
    • 25% increase in urine M-component (absolute increase >= 200mg/24hour
    • 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)
    • 25% increase in bone marrow plasma cell percentage (absolute increase of >=10%)
    • Definite development of new bone lesion or soft tissue plasmacytomas

    Measured: Duration of study (up to 5 years)

  2. Duration of Response

    Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. Kaplan Meier method was used to compute this outcome.

    Measured: Duration of study (up to 5 years)

Timeline

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

  1. First posted15 Nov 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionSep 2012
  4. Study completion25 Oct 2017

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00558896
Sponsor's protocol ID
CDR0000574742
Other IDs
P30CA015083, 07-003064, NCI-2009-01283, MC0789
Status last verified
Mar 2018
First submitted
14 Nov 2007
Last updated
18 Apr 2018
Data monitoring committee
Yes

Publications

  • Dispenzieri A, Buadi F, Laumann K, LaPlant B, Hayman SR, Kumar SK, Dingli D, Zeldenrust SR, Mikhael JR, Hall R, Rajkumar SV, Reeder C, Fonseca R, Bergsagel PL, Stewart AK, Roy V, Witzig TE, Lust JA, Russell SJ, Gertz MA, Lacy MQ. Activity of pomalidomide in patients with immunoglobulin light-chain amyloidosis. Blood. 2012 Jun 7;119(23):5397-404. doi: 10.1182/blood-2012-02-413161. Epub 2012 Apr 4.

    PubMed 22493299

  • Lacy MQ, Allred JB, Gertz MA, Hayman SR, Short KD, Buadi F, Dispenzieri A, Kumar S, Greipp PR, Lust JA, Russell SJ, Dingli D, Zeldenrust S, Fonseca R, Bergsagel PL, Roy V, Stewart AK, Laumann K, Mandrekar SJ, Reeder C, Rajkumar SV, Mikhael JR. Pomalidomide plus low-dose dexamethasone in myeloma refractory to both bortezomib and lenalidomide: comparison of 2 dosing strategies in dual-refractory disease. Blood. 2011 Sep 15;118(11):2970-5. doi: 10.1182/blood-2011-04-348896. Epub 2011 Jun 20.

    PubMed 21690557

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dexamethasone and pomalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 3 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?

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 Apr 2018. 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 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 5 Jun 2014). 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?

The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response) (time frame: Duration of study (up to 3 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 NCT00558896, 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 18 Apr 2018.

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