A Study of Daratumumab With Pomalidomide, Dexamethasone, and All-Transretinoic Acid in Patients With Multiple Myeloma

Stopped early · Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to test the safety and efficacy of the study drug daratumumab, when given together with Pomalidomide, Dexamethasone, and All-Transretinoic Acid (ATRA).

Key facts

Study ID

NCT04700176

Run by

Hackensack Meridian Health

People needed

1

Starts

2022-05-02

Expected to finish

2023-11-15

Last updated by the study team

2025-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented multiple myeloma
• For cohort A, patients must have been previously exposed to Dara+Len+Dex and must have achieved at least stable disease to this combination.
• For cohort B, patients must have been exposed to Dara + Pom + Dex and must have achieved at least stable disease to this combination.
• Histologically confirmed and relapsed multiple myeloma with measurable disease, defined by at least one of the following:
• Serum monoclonal protein ≥0.5 g/dL;
• Monoclonal protein in the urine on 24-hour electrophoresis ≥200 mg;
• Serum immunoglobulin free light chain (FLC) ≥10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal;
• New of progressing biopsy proven plasmacytoma on exam or imaging; or
• Bone marrow plasma cells ≥20%;
• Cycle 1 day 1 of study treatment must be within 3 months of last exposure to Daratumumab.
• Life expectancy >3 months
• ECOG PS 0-2
• Age ≥18
• Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within the Screening Period, defined as:
• Absolute neutrophil count (ANC) ≥1,000/μL;
• Platelet count ≥50,000/μL, (≥30,000/μL if bone marrow plasma cells are ≥50% of cellularity);
• Hemoglobin ≥7.5g/dL;
• Creatinine clearance ≥60 mL/min (assessed as glomerular filtration rate using the Cockcroft-Gault formula);
• Alanine aminotransferase or aspartate aminotransferase <3 x upper limit of normal (ULN);
• Total bilirubin <2 x ULN (except for patients with Gilbert's syndrome confirmed by UGT1A1 mutation);
• Left ventricular ejection fraction ≥50% as assessed by echocardiography or multi-gated acquisition (MUGA) scan; and
• Must have a minimum level of pulmonary reserve defined as Grade <2 dyspnea and pulse oxygenation ≥92% on room air;
• Prior to first dose of study drug, a woman must be either:
• Not of childbearing potential: premenarchal; postmenopausal (>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone level >40 IU/L or mIU/mL]); permanently sterilized (eg, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
• Of childbearing potential and practicing a highly effective method of birth control for 4 weeks before initiating study treatment that is consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject) Note: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche)

You may not qualify if…

• Major concurrent illness or organ dysfunction
• Active GVHD requiring systemic corticosteroids in a subject who previously received allogeneic-SCT.
• Cord compression or CNS involvement
• Recent/Prior active malignancy requiring active therapy 2 years prior to enrollment excluding non-melanoma skin cancer.
• Prior life-threatening hypersensitivity to daratumumab or an IMiD
• Plasma cell leukemia
• Pregnant or lactating females
• Men donating sperm during study
• 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)
• Chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal

Where it is running

• John Theurer Cancer Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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