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Protocol No.16102GCCPrincipal InvestigatorBadros, Ashraf
PhasePhase II
Age GroupAdult
Title16102GCC: Phase 2, Randomized, Open-Label Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Patients With Newly Diagnosed Multiple Myeloma Eligible for High-Dose Chemotherapy and Autologous Stem Cell Transplantation
DescriptionThe study is being done primarily to look at whether or not adding daratumumab to standard of care treatment — Revlimid® (lenalidomide), Velcade® (bortezomib), and dexamethasone (RVd) — will help patients with newly diagnosed Multiple Myeloma achieve a better response after receiving treatment with RVd, with or without daratumumab, and an autologous stem cell transplant (ASCT). A better response is a treatment outcome where there are ≤ 5% plasma cells in the bone marrow and no evidence of myeloma proteins in your serum or urine by lab testing. The study will examine whether adding daratumumab to RVd treatment affects the effectiveness of treatment, compared to RVd alone.
TreatmentAdding daratumumab to standard of care treatment — Revlimid® (lenalidomide), Velcade® (bortezomib), and dexamethasone (RVd)
Key EligibilityInclusion Criteria
Each potential subject must satisfy all of the following criteria to be enrolled in the study:
1. 18 to 70 years of age, inclusive.
2. considered by the investigator to be eligible for HDT and ASCT according to the
institution’s criteria based on age, medical history, cardiac and pulmonary status,
overall health and condition, co-morbid condition(s), physical examination, and
laboratory studies.
3. have documented multiple myeloma as defined by the criteria below:
a. Monoclonal plasma cells in the bone marrow 10% or presence of a biopsy proven
b. Evidence of end organ damage that can be attributed to the underlying plasma cell
proliferative disorder, specifically (1 or more of the following):
i. Hypercalcemia: serum calcium >1 mg/dL higher than the upper limit of
normal (ULN) or >11 mg/dL
ii. Renal insufficiency: CrCl <40 mL/min (measured or estimated by validated
equations; Attachment 2) or serum creatinine >177 μmol/L (>2 mg/dL)
iii. Anemia: hemoglobin value of >2.0 g/dL below the lower limit of normal, or a
hemoglobin value <10.0 g/dL
iv. Bone lesions: 1 or more osteolytic lesions on skeletal radiography, computed
tomography (CT), magnetic resonance imaging (MRI) or positron emission
tomography (PET)-CT
c. Measurable disease as defined by any of the following:
i. Serum M-protein level 1.0 g/dL or urine M-protein level 200 mg/24 hours.
Note: All attempts should be made to determine eligibility of the subject based
on the central laboratory results of screening blood and urine M-protein
measurements. In exceptional circumstances, the local laboratory results of
blood and urine M-protein measurements may be used to determine eligibility,
but only if the results are clearly (eg, 25% or more) above the thresholds for
measurability; or
ii. IgA, IgD, IgE, or IgM multiple myeloma: serum M-protein level 0.5 g/dL or
urine M-protein level 200 mg/24 hours; or
iii. Light chain multiple myeloma without measurable disease in the urine: serum
Ig FLC 10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio.
4. has not had prior systemic therapy for multiple myeloma. An emergency course of
steroids (defined as no greater than 40 mg of dexamethasone, or equivalent per day for
a maximum of 4 days (ie, a total of 160 mg) is permitted. In addition, radiation therapy
is permitted prior to study entry, during screening, and during Cycles 1-2 of study
treatment as needed for lytic bone disease.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
(refer to Attachment 3).
6. woman of childbearing potential must have 2 negative highly sensitive serum
(-human chorionic gonadotropin [-hCG]) during screening, the first one within
10 to 14 days prior to the first dose of any component of study treatment and the
second within 24 hours prior to the first dose of any component of study treatment.
7. before randomization, a woman must be either:
a. Not of childbearing potential defined as:
o postmenopausal
A postmenopausal state is defined as no menses for 12 months without
an alternative medical cause. A high follicle stimulating hormone level
(>40 IU/L or mIU/mL in the postmenopausal range may be used to
confirm a postmenopausal state in women not using hormonal
contraception or hormonal replacement therapy, however in the absence
of 12 months of amenorrhea, a single follicle stimulating hormone
measurement is insufficient.
o permanently sterile
Permanent sterilization methods include hysterectomy, bilateral
salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral
b. Of childbearing potential and
o practicing 2 highly effective user-independent methods of contraception (failure rate of <1% per year when used consistently and correctly

Applicable Disease SitesMultiple Myeloma
Therapies InvolvedImmunotherapy
Drugs InvolvedBortezomib
PS-341 (Bortezomib)
Velcade (Bortezomib)
Treatment TypeTreatment
ContactGreenebaum Cancer Center Sherri Bauman, R.N. Phone:410-328-1561
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