A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma

Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:18 - Any
Start Date:September 25, 2017
End Date:September 2020
Contact:Ola Landgren, MD, PhD

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Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Newly-Diagnosed Multiple Myeloma: A Clinical and Correlative Phase II Study

This is a study to test the safety and effectiveness of the study drug, daratumumab in
combination with carfilzomib, lenalidomide and dexamethasone. The purpose of this study is to
test whether giving daratumumab along with the other drugs (carfilzomib, lenalidomide and
dexamethasone) is safe for patients.

Inclusion Criteria:

- Newly diagnosed patients with histologically confirmed MM based on the following

- Clonal plasma cells in the bone marrow

- Measurable disease within the past 4 weeks defined by any one of the following:

- Serum monoclonal protein ≥ 1.0 g/dL

- Urine monoclonal protein >200 mg/24 hour

- Involved serum immunoglobulin free light chain > 10 mg/dL AND abnormal
kappa/lambda ratio

- Evidence of underlying end organ damage and/or myeloma defining event attributed to
underlying plasma cell proliferative disorder meeting at least one of the following:

- Hypercalcemia: serum calcium >0.25 mmol/L (> 1 mg/dL) above upper limit of normal
or ≥ 2.75 mmol/L (11 mg/dL)

- Anemia: hemoglobin value <10 g/dL or > 2 g/dL below lower limit of normal

- Bone disease: ≥ 1 lytic lesions on skeletal X-ray, CT, or PET-CT. For patients
with 1 lytic lesion, bone marrow should demonstrate ≥10% clonal plasma cells

- Clonal bone marrow plasma cell percentage ≥60%

- Involved/un-involved serum free light chain ratio ≥100 and involved free light
chain >100 mg/L.

- 1 focal lesion on magnetic resonance imaging study (lesion must be >5 mm) in

- Creatinine Clearance ≥ 60 ml/min. CrCl can be measured or estimated using
Cockcroft-Gault method, MDRD, or CKD-EPI formulae

- Age ≥ 18 years at the time of signing the informed consent documentation

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Absolute neutrophil
count (ANC) ≥ 1.0 K/uL, hemoglobin ≥ 8 g/dL, and platelet count ≥ 75 K/uL, unless if
cytopenias are deemed to be due disease at discretion of clinical investigator.
Transfusions and growth factors are permissible.

- Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 3.0 x

- All study participants must be able to tolerate one of the following
thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin
(coumadin) or alternative anti-coagulant.

- All study participants must be registered into the mandatory eREMS® program, and be
willing and able to comply with the requirements of REMS®.

- Females of childbearing potential (FCBP)† must have a negative serum or urine
pregnancy test within 10 - 14 days and again within 24 hours prior to prescribing
lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either
commit to continued abstinence from heterosexual intercourse or begin TWO acceptable
methods of birth control, one highly effective method and one additional effective
method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP
must also agree to ongoing pregnancy testing. Men must agree to use a latex condom
during sexual contact with a FCBP even if they have had a successful vasectomy.

- A female of childbearing potential is a sexually mature female who: 1) has not
undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal for at least 24 consecutive months (i.e., has had menses at any
time in the preceding 24 consecutive months).

Exclusion Criteria:

- Patients receiving >1 cycle of prior treatment or concurrent systemic treatment for
multiple myeloma

- Treatment of hypercalcemia or spinal cord compression or aggressively progressing
myeloma with current or prior corticosteroids is permitted

- Bisphosphonates are permitted

- Concurrent or prior treatment with corticosteroids for indications other than
multiple myeloma is permitted

- Prior treatment with radiotherapy is permitted

- Prior treatment for smoldering myeloma is permitted with a washout period of 2
weeks from last dose. Smoldering patients previously treated with carfilzomib are

- Patients with measurable disease who received up to one cycle of any therapy
within 60 days with a washout period of 2 weeks from last dose (on a trial or
outside a trial) are eligible

- Plasma cell leukemia

- POEMS syndrome

- Amyloidosis

- Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1
second (FEV1) <50% of predicted normal (note that FEV1 testing is required for
subjects suspected of having chronic obstructive pulmonary disease and subjects must
be excluded if FEV1 <50% of predicted normal).

- Pregnant or lactating females. Because there is a potential risk for adverse events
nursing infants secondary to treatment of the mother with carfilzomib in combination
with lenalidomide. These potential risks may also apply to other agents used in this

- Uncontrolled hypertension or diabetes Active hepatitis B or C infection

- Known or suspected HIV or serologically positive

- Has significant cardiovascular disease with NYHA Class III or IV symptoms, EF<40% or
hypertrophic cardiomyopathy, or restrictive cardiomyopathy, or myocardial infarction
within 6 months prior to enrollment, or unstable angina, or unstable arrhythmia as
determined by history and physical examination. Echocardiogram will be performed
during screening evaluation.

- Pulmonary hypertension

- Has refractory GI disease with refractory nausea/vomiting, inflammatory bowel disease,
or bowel resection that would prevent absorption of oral agents

- Uncontrolled intercurrent illness including but not limited to active infection or
psychiatric illness/social situations that would compromise compliance with study

- Significant neuropathy ≥Grade 3 or Grade 2 neuropathy with pain at baseline

- Contraindication to any concomitant medication, including antivirals or

- Major surgery within 3 weeks prior to first dose
We found this trial at
Middletown, New Jersey 07748
Phone: 212-639-5126
Middletown, NJ
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
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Basking Ridge, NJ
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Commack, New York 11725
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Commack, NY
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500 Westchester Avenue
Harrison, New York 10604
Phone: 212-639-5126
Harrison, NY
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225 Summit Avenue
Montvale, New Jersey 07645
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Montvale, NJ
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Ola Landgren, MD,PhD
Phone: 212-639-5126
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
New York, NY
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Rockville Centre, New York 11570
Phone: 212-639-5126
Rockville Centre, NY
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