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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Testing the Addition of Daratumumab-Hyaluronidase to Enhance Therapeutic Effectiveness of Lenalidomide in Smoldering Multiple Myeloma, The DETER-SMM Trial

Multiple Myeloma

This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab-hyaluronidase in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as dexamethasone lower the bodys immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab-hyaluronidase is a monoclonal antibody, daratumumab, that may interfere with the ability of cancer cells to grow and spread, and hyaluronidase, which may help daratumumab work better by making cancer cells more sensitive to the drug. Giving lenalidomide and dexamethasone with daratumumab-hyaluronidase may work better in treating patients with smoldering myeloma.
Multiple Myeloma
III
Baljevic, Muhamed
NCT03937635
ECOGPCLEAA173

Testing the Addition of a New Drug, Daratumumab/rHuPH20, to the Usual Treatment (Lenalidomide) as Post-stem Cell Transplant Treatment for Multiple Myeloma, DRAMMATIC Study

Multiple Myeloma

This phase III trial compares the effect of usual treatment (lenalidomide) to using daratumumab/rHuPH20 plus the usual treatment after stem cell transplantation in patients with multiple myeloma. This drug combination may help patients live longer after their stem cell transplant. Another purpose of this study is to learn if the presence and amount of minimal residual disease (MRD) can help doctors predict when a patients multiple myeloma will get worse. MRD is the name for the small number of cancer cells that remain in the patient even after their multiple myeloma has been treated and they have no symptoms of the disease. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with daratumumab/rHuPH20, may induce changes in bodys immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and daratumumab/rHuPH20 may work better in treating patients with multiple myeloma compared to lenalidomide alone.
Multiple Myeloma
III
Baljevic, Muhamed
NCT04071457
VICC-NTPCL23369

Testing the Use of Combination Therapy in Adult Patients with Newly Diagnosed Multiple Myeloma, the EQUATE Trial

Multiple Myeloma

This phase III trial compares the combination of four drugs (daratumumab-hyaluronidase, bortezomib, lenalidomide and dexamethasone) to the use of a three-drug combination (daratumumab-hyaluronidase, lenalidomide and dexamethasone) in patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab-hyaluronidase is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the bodys immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab-hyaluronidase, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on a combination of daratumumab-hyaluronidase, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma.
Multiple Myeloma
III
Baljevic, Muhamed
NCT04566328
ECOGPCLEAA181

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets

Multiple Cancer Types

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma
cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of
ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change
in disease activity will be assessed.

ABBV-453 is an investigational drug being developed for the treatment of R/R MM. Part 1 will
be a monotherapy dose escalation phase to determine the best dose of ABBV-453. In Part 2,
participants are placed in 1 of 3 groups called treatment arms. Each group receives a
different treatment. Approximately 28 to 48 adult participants in Part 1 and 150 to 312 adult
participants in Part 2 with R/R MM will be enrolled in the study in approximately 70 sites
worldwide.

In Part 1 and the Japan Cohort, Participants will receive oral ABBV-453 tablets once daily
(QD) in 28-day cycles. In Part 2, Arm 1, participants will receive continuous doses of oral
ABBV-453 tablets QD in combination with oral dexamethasone tablets once weekly in 28-day
cycles. In Part 2, Arm 2, participants will receive continuous doses of oral ABBV-453 tablets
QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks and oral
dexamethasone tablets once weekly in, 28-day cycles. In Part 2, Arm 3, participants will
receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous
injections of daratumumab every 1 to 4 weeks, oral lenalidomide capsules QD on Days 1-21, and
oral dexamethasone tablets once weekly, in 28-day cycles.

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked by
medical assessments, blood tests, and side effects.
Multiple Myeloma, Phase I
I
Baljevic, Muhamed
NCT05308654
VICCHEMP2230

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Multiple Cancer Types

The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination
with talquetamab or teclistamab, and to characterize the safety and tolerability of
talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.
Multiple Myeloma, Phase I
I
Baljevic, Muhamed
NCT05338775
VICCHEMP2253

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