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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma

Clinicaltrials.gov identifier NCT03590652

Recruitment Status Recruiting

First Posted July 18, 2018

Last update posted January 9, 2020

Study Description

Brief summary:

The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone.

  • Condition or Disease:Relapsed/Refractory Multiple Myeloma
  • Intervention/Treatment: Drug: Ixazomib
    Drug: Pomalidomide
    Drug: Dexamethasone
    Drug: Daratumumab
  • Phase: Phase 2
Detailed Description

The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone. The drugs being used in this study are daratumumab ixazomib, pomalidomide, and dexamethasone. Ixazomib may stop the growth of cancer by interfering with proteasomes (the protein breakdown mechanism in the cells). Pomalidomide, and dexamethasone are standard drugs that can change and regulate the immune system and may stop cancer cells from growing. Both Ixazomib and Daratumumab are approved for use in Multiple Myeloma, but not in this combination.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 46 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Phase II Study of the Combination of Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma A University of California Hematologic Malignancies Consortium Protocol (UCHMC1809)
  • Actual Study Start Date: October 2018
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: October 2021
Arms and interventions
Arm Intervention/treatment
Experimental: ixazomib, daratumumab, pomalidomide and dexamethasone
Daratumumab will be administered at 16mg/kg IV weekly x 8 weeks, biweekly x 8 weeks, then monthly. Pomalidomide 4mg will be administered orally daily for days 1-21. Patients ≤ age 75 will receive a 40mg dose of dexamethasone, and those over the age of 75 may receive a 20mg dose of dexamethasone orally on days 1, 8, 15, and 22 (weekly). Ixazomib will be administered 4mg orally on days 1, 8 and 15.
Drug: Ixazomib
4mg PO days 1,8,15 on 28-day cycle

Drug: Pomalidomide
4mg days PO 1-21/28 days

Drug: Dexamethasone
40mg** PO weekly ** starting dose for age >75 may be 20mg

Drug: Daratumumab
16mg/kg IV weekly x 8 weeks, biweekly x 8 doses, then monthly
Outcome Measures
  • Primary Outcome Measures: 1. Overall Response Rate [ Time Frame: 2 years ]
  • 2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 2 years ]
    Treatment-emergent Grade 2-5 adverse events (AEs) will be assessed using NCI CTCAE v4.03 toxicity criteria
  • Secondary Outcome Measures: 1. Clinical benefit rate [ Time Frame: 2 years ]
    CBR: minimal response +ORR
  • 2. Progression free survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Progression-free survival (PFS) is defined as the duration of time from start of treatment until objective tumor progression or death
  • 3. Time to progression [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Time to progression is defined as the duration of time from start of treatment until objective tumor progression.
  • 4. Overall survival (OS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Overall survival is defined as the duration of time from start of treatment to death
  • 5. Minimal Residual Disease (MRD) [ Time Frame: 1 year ]
  • 6. Quality of life (QOL) scores [ Time Frame: 2 years ]
    Cancer Therapy Satisfaction Questionnaire and EORTC QLQ-MY20
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- All 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.

- Confirmed diagnosis of Multiple Myeloma having received 1 and 3 prior lines of
treatment

- Relapsed and/or refractory disease

- Measurable disease

- Life expectancy of more than 3 months

- ECOG performance status of 0, 1, or 2

- No prior progression on pomalidomide

- All pts must have received prior lenalidomide therapy and been determined to be
relapsed and/or refractory.

- Adequate hepatic function

- Adequate renal function

- Additional Laboratory Requirements

1. ANC ≥1.0 x 10^9/L, Hgb ≥8 g/dL (transfusion permitted)

2. Platelet count ≥75 x 10^9/L (≥ 50x10^9/L if bone marrow plasma cells are ≥50% of
cellularity)

- Women of child-bearing potential and men with partners of child-bearing potential must
agree to use 2 methods of birth control or be surgically sterile or abstain from
heterosexual activity from the time of signing the informed consent for through 120
days after the last dose of study medication.

- Women of childbearing potential have negative pregnancy test within 72 hours of
initiating study drug dosing.

- Male subjects must agree to use a latex condom during sexual contact with females of
childbearing potential even if they have had a successful vasectomy starting with the
first dose of study therapy through 120 days after the last dose of study therapy.

- All subjects must be counseled at a minimum of every 28 days about pregnancy
precautions and risks of fetal exposure.

- Females of reproductive potential must adhere to the scheduled pregnancy testing as
required in the POMALYST REMS program.

- Subjects must agree to take enteric-coated aspirin 81 mg orally daily, or if history
of prior thrombotic disease, must be fully anticoagulated with warfarin (INR 2-3) or
be treated with full-dose, low molecular weight heparin, as if to treat deep venous
thrombosis (DVT)/pulmonary embolism (PE) at the investigator's discretion.

Exclusion Criteria:

- Current or anticipated use of other investigational agents.

- Prior daratumumab or ixazomib use

- Patients who are refractory to pomalidom

- Non-secretory or hyposecretory multiple myeloma defined as:

- Plasma cell leukemia (>2.0 x 10 9/L circulating plasma cells by standard differential)

- Waldenström's macroglobulinemia or IgM myeloma

- Known central nervous system involvement by multiple myeloma

- Radiotherapy to multiple sites or immunotherapy within 2 weeks before enrollment
(localized radiotherapy to a single site at least 1 week before start is permissible)

- Participation in an investigational therapeutic study within 3 weeks or within 5 drug
half-lives (t1/2) prior to first dose, whichever time is greater. Non-interventional
trials (i.e. observational trials) are permitted at any time point

- Female patients who are lactating or have a positive serum pregnancy test during the
screening period.

- Major surgery within 3 weeks prior to first dose

- Myocardial infarction within 6 months prior to enrollment, NYHA (New York Heart
Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled
ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active
conduction system abnormalities

- Acute active infection requiring systemic antibiotics, antivirals, or antifungals
within two weeks prior to first dose

- Systemic treatment, within 14 days before the first dose of ixazomib, with strong
CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin,
phenobarbital), or use of St. John's wort.

- Known or suspected HIV infection, known HIV seropositivity

- Active hepatitis infection

- Diagnosed or treated for another malignancy within 2 years before study enrollment or
previously diagnosed with another malignancy and have any evidence of residual
disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are
not excluded if they have undergone complete resection.

- Subjects with known or suspected light chain amyloidosis of any organ.

- Known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human
proteins, Daratumumab, or its excipients. or known sensitivity to mammalian-derived
products.

- Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1
second (FEV1) <50% of predicted normal - Has known moderate or severe persistent asthma within the past 2 years per asthma guidelines - Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance of ixazomib or pomalidomide, including difficulty swallowing

Contacts and Locations
Contacts

Contact: Caitlin Costello, MD 858-822-6600 ccostello@ucsd.edu

Contact: Elaine Eng e1eng@ucsd.edu

Locations

United States, California
UCSD Moores Cancer Center
La Jolla

Sponsors and Collaborators

Caitlin Costello, MD

Celgene

Takeda

Janssen, LP

Investigators

Principal Investigator: Caitlin Costello, MD University of California, San Diego

More Information
  • Responsible Party: Caitlin Costello, MD
  • ClinicalTrials.gov Identifier: NCT03590652 History of Changes
  • Other Study ID Numbers: 180638
  • First Posted: July 18, 2018 Key Record Dates
  • Last Update Posted: January 9, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Caitlin Costello, MD: Dexamethasone
    Daratumumab
    Pomalidomide
    Ixazomib
    cancer
    Phase 2
    Darzalex
    Pomalyst
    Ninlaro
    Decadron
    multiple myeloma
    relapsed/refractory multiple myeloma
  • Additional relevant MeSH terms: Multiple Myeloma Neoplasms, Plasma Cell