Status:
WITHDRAWN
Study of Combination POM, BTZ, Low-Dose DEX, and DARA (PVD-DARA) in Patients With RRMM
Lead Sponsor:
Alliance Foundation Trials, LLC.
Collaborating Sponsors:
Janssen, LP
Celgene
Conditions:
Relapsed or Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase II clinical trial design with a safety run-in period will be used to assess the rate of VGPR or better for the combination PVD-Dara in the treatment of RRMM.
Detailed Description
A phase II clinical trial design, including an initial safety run-In period, will be used to assess the rate of VGPR or better for the combination PVD-Dara in the treatment of relapsed or refractory m...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed diagnosis of symptomatic multiple myeloma.
- Evidence of disease progression or refractoriness to 1 to 3 prior lines of therapy by IMWG standard criteria.
- Prior exposure to lenalidomide and a proteasome inhibitor is mandatory.
- Daratumumab naïve patients or Daratumumab exposed patients who are not refractory to weekly or bi-weekly daratumumab.
- Measurable disease:
- Serum M protein ≥ 0.5 g/dL
- Urine M protein ≥ 200 mg/24 hours
- Involved serum free light chains ≥ 10 mg/dL AND an abnormal serum free light chain ratio
- ECOG Status 0-2 ≤ 14 days prior to registration
- Adequate organ function including ≤ 14 days prior to registration defined as:
- ANC ≥ 1.0 x 10\^9/L. (Patients cannot have received G-CSF or GM-CSF within 1 week of screening or pegfilgrastim within 2 weeks of screening)
- Platelets ≥ 75 x 10\^9/L
- Calculated Creatinine Clearance ≥ 30 mL/min
- Total Bilirubin ≤ 1.5 x ULN except for patients with a history of elevated total bilirubin, such as in Gilbert's
- AST, AP, ALT ≤ 3 x ULN
- Hepatic Child-Pugh score at worse A (eligible for the phase 2 part but not for the Run-in-Period).
- Adequate cardiac function within 8 weeks prior to registration defined as LVEF ≥ 40%.
- Key
Exclusion
- Disease refractory to weekly or bi-weekly daratumumab therapy.
- Female patients who are lactating or have a positive serum pregnancy test ≤ 14 days from registration during the screening period.
- Failure to have fully recovered from the reversible effects of prior anti-cancer therapy.
- Major surgery within 14 days before registration.
- Focal radiation therapy within 14 days prior to randomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma.
- Disease-related central nervous system involvement.
- Plasma cell leukemia, AL amyloidosis, or POEMS syndrome.
- The subject has uncontrolled significant intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled congestive heart failure, New York Heart Association Class III-IV, unstable angina pectoris, stroke, myocardial infarction, uncontrolled cardiac arrhythmias \< 6 months prior to registration, or uncontrolled hypertension.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Known GI disease or GI procedure that could interfere with the oral absorption of study medication including difficulty swallowing.
- Concurrent malignancy except for treated non-melanoma skin cancer, cervical carcinoma in situ and low-risk prostate CA being monitored without treatment.
- Grade 2 and higher peripheral neuropathy on clinical examination ≤ 14 days prior to registration.
- Chemotherapy ≤ 14 days prior to registration.
- Exposure to an investigational drug (including investigational vaccine) or invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic half-lives, whichever is longer.
- Patients with known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal; moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note.
- Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate.
- Patients who have a contraindication to the use of any form of anticoagulation or antiplatelet agents.
- Patient who are on a strong CYP34A or CYP1A2 inducer or inhibitors
- Patients with Hepatic Child-Pugh score B and C. Note that Hepatic Child-Pugh score A are excluded from the Run-in-Period of the trial
- Patient is:
- seropositive for human immunodeficiency virus (HIV).
- seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
- seropositive for hepatitis C (except in the setting of a sustained virologic response \[SVR\], defined as aviremia at least 12 weeks after completion of antiviral therapy).
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05408026
Start Date
October 1 2022
End Date
February 1 2026
Last Update
January 27 2023
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