Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting

  • STATUS
    Recruiting
  • End date
    May 1, 2025
  • participants needed
    156
  • sponsor
    Celgene
Updated on 16 April 2020
Investigator
Associate Director Clinical Trial Disclosure
Primary Contact
Bay Area Cancer Research Group, LLC (3.1 mi away) Contact
+47 other location
vasectomy
measurable disease
bone marrow procedure
dexamethasone
lenalidomide
daratumumab
refractory multiple myeloma
pomalidomide

Summary

This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy.

This trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide.

This trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide.

This trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of >60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.

Description

A phase 2, multicenter, multi-cohort, open-label study of pomalidomide in combination with low-dose dexamethasone or pomalidomide in combination with low-dose dexamethasone and daratumumab in subjects with relapsed or refractory multiple myeloma following lenalidomide based therapy in the first or second line setting.

This trial will assess, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), Duration of Response (DoR), Time to Response (TTR), Time to Progression(TTP) and safety.

Details
Treatment Pomalidomide, Dexamethasone, Daratumumab
Clinical Study IdentifierNCT01946477
SponsorCelgene
Last Modified on16 April 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Lymphoproliferative disorders or Lymphoproliferative Disorder or Multiple Myeloma?
Subjects must satisfy the following criteria to be enrolled in the study
Adults (age 18 years at the time of signing the ICD) with documented diagnosis of MM and measurable disease (serum M-protein 0.5 g/dL or urine M-protein 200 mg/24 hours)
Subjects enrolling in Cohort A (POM+LD-dex) must have received 2 prior treatment lines of anti-myeloma therapy. Subjects enrolling in Cohort B and Cohort C (POM+DARA+LD-dex) must have received 1 or 2 prior treatment lines of anti-myeloma therapy
All subjects must have received prior treatment with LEN or a LEN-containing regimen for at least 2 consecutive cycles as the most recent treatment regimen
All subjects must have documented disease progression during or after their last antimyeloma therapy
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Subjects must understand and voluntarily sign an ICD prior to any study related assessments/procedures being conducted
Subjects must be able to adhere to the study visit schedule and other protocol requirements
All subjects must provide an adequate bone marrow sample at screening that definitively evaluates the presence or absence of myelodysplastic changes
Females with child-bearing potential (FCBP) must agree to use 2 reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including during dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe. For subjects enrolled in Cohort B and Cohort C, pregnancy prevention and testing will continue until 3 months after last dose of daratumumab
Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation. Female subjects enrolled in Cohort B and Cohort C must agree to abstain from breastfeeding and donating eggs during study participation and until 3 months after last dose of daratumumab
Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy. Male subjects enrolled in Cohort B and Cohort C must agree to use a latex condom during any sexual contact with FCBP while participating in the study and until 3 months after last dose of daratumumab
Males must also agree to refrain from donating semen or sperm during the treatment phase and for 28 days after discontinuation from this study treatment. Male subjects enrolled in Cohort B and Cohort C must also agree to refrain from donating semen or sperm during the treatment phase and until 3 months after last dose of daratumumab
All subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment
All subjects must agree not to share medication

Exclusion Criteria

The presence of any of the following will exclude a subject from study
enrollment
Any of the following laboratory abnormalities
Absolute neutrophil count < 1,000/L
Platelet count < 75,000/L for subjects in whom < 50% of bone marrow nucleated
cells are plasma cells; or a platelet count < 30,000/L for subjects in whom
% of bone marrow nucleated cells are plasma cells
Severe renal impairment (Creatinine Clearance [CrCl] < 30 mL/min) requiring
dialysis
Corrected serum calcium > 11.5 mg/dL (> 2.8 mmol/L)
Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior red blood cell transfusion or recombinant human erythropoietin use is permitted)
Serum SGOT/AST or SGPT/ALT > 3.0 x the upper limit of normal (ULN)
Serum total bilirubin > 2.0 mg/dL (34.2 mol/L); or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinemia 2\. Prior history of malignancies, other than MM, unless the subject has been free of the disease for more than 5 years. Allowed exceptions include the following
Basal or squamous cell carcinoma of the skin
Carcinoma in situ of the cervix or breast
Incidental histological finding of prostate cancer (TNM [tumor, nodes
metastasis] stage of T1a or T1b)
\. Previous therapy with pomalidomide or daratumumab
\. Hypersensitivity to thalidomide, LEN, or dex (this includes Grade 3 rash
during prior thalidomide or LEN therapy)
\. Subjects who received an allogeneic bone marrow or allogeneic peripheral
blood stem cell transplant less than 12 months prior to initiation of study
treatment and who have not discontinued immunosuppressive treatment for at
least 4 weeks prior to initiation of study treatment and are currently
dependent on such treatment
\. Subjects with any one of the following
Congestive heart failure (NY Heart Association Class III or IV)
Myocardial infarction within 12 months prior to starting study treatment
Unstable or poorly controlled angina pectoris, including Prinzmetal's variant angina pectoris 7\. Subjects who received any of the following within 14 days of initiation of study
treatment
Major surgery (kyphoplasty is not considered major surgery)
Use of any anti-myeloma drug therapy
\. Use of any investigational agents including for the treatment of multiple
myeloma within 28 days or 5 half-lives (whichever is longer) of treatment
unless approved by the sponsor
\. Incidence of gastrointestinal disease that may significantly alter the
oral absorption of Pomalidomide
\. Subjects unable or unwilling to undergo antithrombotic prophylactic
treatment
\. Any serious medical condition, laboratory abnormality, or psychiatric
illness, that would preclude participation in the study, or interfere with
interpretation of the study results
\. Pregnant or breastfeeding females
\. Known human immunodeficiency virus (HIV) positivity; active infectious
hepatitis A, B, or C; or chronic hepatitis B or C
All subjects will be tested for hepatitis B surface antigen (HBsAg), hepatitis
B surface antibody (antiHBs), and hepatitis B core antibody (antiHBc)
Subjects with the following serological testing are considered not eligible
HBsAg positive
HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA
Note
Subjects who are HBsAg negative, anti-HBs positive, and/or anti-HBc positive, viral DNA negative are eligible. For these subjects, DNA monitoring and prophylactic medication for HBV reactivation are recommended per local practice
Subjects who are seropositive because of hepatitis B virus vaccination are eligible (anti-HBs positive, anti-HBc negative, and HBsAg negative)
All subjects will be tested for hepatitis C antibody. Subjects are not
eligible if known seropositive for hepatitis C virus
Note
Subjects who are hepatitis C antibody positive but show no detectable viral
RNA for 6 months prior to initiation of study treatment are eligible
\. For subjects enrolling in Cohort B and Cohort C - Subject has known
allergies, hypersensitivity to mannitol, corticosteroids, monoclonal
antibodies or human proteins, or their excipients (refer to the Daratumumab
IB), or known sensitivity to mammalian-derived products
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet