NCT01541332

Brief Summary

The purpose of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of a combination of three different drugs, pomalidomide, pegylated liposomal doxorubicin, and dexamethasone when used to treat relapsed (the disease came back) or refractory (the disease did not respond to past treatment) multiple myeloma. Different dosages (amount of study drug) of pomalidomide are first being tested to determine if there are any side effects or risks associated with combining this study drug with the other two listed. Once the optimal dose is decided on, the study will change its focus to determining the effectiveness of the study drug in this combination.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline
Completed

Started Feb 2012

Typical duration for phase_1 multiple-myeloma

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

4.8 years

First QC Date

February 20, 2012

Last Update Submit

March 8, 2016

Conditions

Multiple Myeloma

Keywords

relapsed refractorymultiple myelomapomalidomideDoxildexamethasoneOncotherapeutics

Outcome Measures

Primary Outcomes (2)

  • MTD of Pomalidomide

    Phase 1: To establish the MTD of pomalidomide in combination with dexamethasone and pegylated liposomal doxorubicin

    12 months

  • Overall Response Rate

    Phase 2: To determine efficacy as evidenced by the best overall response rate (CR + VGPR + PR + MR) following treatment with pomalidomide, dexamethasone and pegylated liposomal doxorubicin

    24 months

Secondary Outcomes (6)

  • Number of Patients with Adverse Events

    24 months

  • Time to Progression

    24 Months

  • Progression-free Survival

    24 Months

  • Time to First Response

    24 Months

  • Duration of Response

    24 Months

  • +1 more secondary outcomes

Study Arms (1)

Pomalidomide + PLD + Dexamethasone

EXPERIMENTAL

Pomalidomide + Pegylated Liposomal Doxorubicin + Dexamethasone in an open label, dose escalation study

Drug: PomalidomideDrug: Pegylated Liposomal Doxorubicin (PLD)Drug: Dexamethasone

Interventions

PomalidomideDRUG

Pomalidomide administered to 3 cohorts of subjects at escalating doses of 2 (cohort 1), 3 (cohort 2) and 4 mg/dose (cohort 3) per orem (PO). Doses are to be administered once-a-day, for the first 21 days, as part of a 28-day treatment cycle, followed by a 7-day rest period.

Also known as: CC-4047
Pomalidomide + PLD + Dexamethasone
Pegylated Liposomal Doxorubicin (PLD)DRUG

Dexamethasone will be given at a dose of 40 mg/dose IV. Doses are to be administered on days 1, 4, 8, and 11 of the 28-day cycle. PLD will be given at a dose of 5.0 mg/m2 as a 60 minute IV infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle.

Also known as: Doxil
Pomalidomide + PLD + Dexamethasone
DexamethasoneDRUG

Dexamethasone will be given at a dose of 40 mg/dose IV. Doses are to be administered on days 1, 4, 8, and 11 of the 28-day cycle.

Also known as: Decadron
Pomalidomide + PLD + Dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of MM based on standard criteria (Durie 1986)
  • Currently has MM with measurable disease, defined as:
  • a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g/dL and/or
  • urine monoclonal protein levels of at least 200 mg/24 hours
  • for patients without measurable serum and urine M-protein levels, an abnormal free light chain ratio (normal value: 0.26 - 1.65)
  • Currently has progressive MM that has relapsed or is refractory, defined as:
  • For the phase 1: Relapsed following stabilization or a response to at least one anti-myeloma regimen or refractory defined as progressed while receiving an anti-myeloma treatment
  • For the phase 2: Refractory to lenalidomide as demonstrated by progressive disease while on lenalidomide or that relapsed within 8 weeks of the last dose of lenalidomide either as a single agent or in combination.
  • Prior treatment with four days or less of a total of 400 mg of prednisone (or an equivalent potency of another steroid) for MM will not be considered a regimen
  • Able to adhere to the study visit schedule and other protocol requirements
  • ECOG performance status of 2 or greater at study entry
  • Life-expectancy of greater than 3 months
  • Lab tests within study ranges at study entry:
  • Absolute neutrophil count \> 1.5 x 109/L
  • Platelet count \> 75 x 109/L
  • +7 more criteria

You may not qualify if:

  • POEMS syndrome
  • Plasma cell leukemia
  • Primary amyloidosis
  • Non-hematologic malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
  • Impaired cardiac function or clinically significant cardiac diseases
  • Severe hypercalcemia
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF
  • 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
  • Undergone major surgery within 28 days prior enrollment or has not recovered from side effects of such therapy (Kyphoplasty is not considered to be a major surgery; however, the investigator is to discuss enrollment of a subject with a recent history of kyphoplasty with the medical monitor)
  • Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)
  • Received the following prior therapy:
  • Pomalidomide
  • Chemotherapy within 3 weeks of study drugs (6 wks for nitrosoureas)
  • Corticosteroids (\>10 mg/day prednisone or equivalent) within 3 weeks of study drugs
  • Immunotherapy or antibody therapy as well as thalidomide, lenalidomide, arsenic trioxide or bortezomib within 21 days before study drugs
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Roy and Patricia Disney Family Cancer Center

Burbank, California, 91505, United States

Location

California Cancer Associates for Research and Excellence

Encinitas, California, 92024, United States

Location

Hematology Oncology Medical Group

Fresno, California, 93720, United States

Location

Pacific Cancer Care

Salinas, California, 93901, United States

Location

Cancer Center of Santa Barbara

Santa Barbara, California, 93105, United States

Location

Mission Hope Cancer Center

Santa Maria, California, 93454, United States

Location

James R Berenson, MD, Inc.

West Hollywood, California, 90069, United States

Location

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pomalidomideliposomal doxorubicinDexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • James R Berenson, MD

    Oncotherapeutics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2012

First Posted

February 29, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 10, 2016

Record last verified: 2016-03

Locations

US(8)