Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma
Status: | Active, not recruiting |
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Conditions: | Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 3/6/2019 |
Start Date: | August 29, 2016 |
End Date: | January 25, 2022 |
Phase 2, Randomized, Open-Label Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma Eligible for High-Dose Chemotherapy and Autologous Stem Cell Transplantation
The purpose of this study is to determine if the addition of daratumumab to
lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants
achieving stringent complete response (sCR), as defined by the International Myeloma Working
Group (IMWG) criteria, by the time of completion of post autologous stem cell transplantation
(ASCT) consolidation treatment, compared with RVd alone.
lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants
achieving stringent complete response (sCR), as defined by the International Myeloma Working
Group (IMWG) criteria, by the time of completion of post autologous stem cell transplantation
(ASCT) consolidation treatment, compared with RVd alone.
Inclusion Criteria:
- Considered by the investigator to be eligible for high-dose chemotherapy (HDT) and
autologous stem cell transplantation (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
- Has not had prior systemic therapy for multiple myeloma. An emergency course of
steroids (defined as no greater than 40 milligram [mg] of dexamethasone, or equivalent
per day for a maximum of 4 days (that is, 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
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Woman of childbearing potential must have 2 negative highly sensitive serum
(beta-human chorionic gonadotropin [b-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
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study (including during dose interruptions), and for 4 weeks
following discontinuation of lenalidomide, and if receiving daratumumab, for 3 months
after the last dose
Exclusion Criteria:
- Diagnosed or treated for malignancy other than multiple myeloma, except: a) Malignancy
treated with curative intent and with no known active disease present for more than
equal to (>= )3 years before randomization; b) Adequately treated non-melanoma skin
cancer, lentigo maligna or in situ malignancies (including but not limited to,
cervical, breast) with no evidence of disease
- Exhibiting clinical signs of or has a known history of meningeal or central nervous
system involvement by multiple myeloma
- Known chronic obstructive pulmonary disease with a forced expiratory volume in 1
second (FEV1) less than (<)50 percent (%) of predicted normal
- Known moderate or severe persistent asthma within the past 2 years or currently has
uncontrolled asthma of any classification
- Known to be seropositive for human immunodeficiency virus, known to have hepatitis B
surface antigen positivity, or known to have a history of hepatitis C. Participants
who completed treatment for hepatitis C at least 6 months prior to screening and have
no detectable circulating hepatitis C virus (HCV) at screening, may participate in the
study. Such participants will be required to undergo regular assessment for HCV
reactivation during their participation in the study. Participants who test positive
for HCV at any time during these assessments will be withdrawn from the study
We found this trial at
36
sites
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