A Phase 1/2 interventional study of Bendamustine in Multiple Myeloma, sponsored by Loyola University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-10.
Sponsored by Loyola University · Phase 1/2, Interventional, and Treatment
The purpose of the study is to determine the safety and efficacy of the use of bendamustine in combination with a commonly used combination chemotherapy to treat relapsed and refractory multiple myeloma. The study will be conducted in two phases. Participants in phase I will receive 1 of 4 escalating doses of bendamustine. Once the maximum tolerated dose of bendamustine is determined, phase II of this trial will begin. Participants in phase II will receive the maximum tolerated dose of bendamustine in combination with standard of care chemotherapy.
Multiple myeloma is a multi-organ neoplastic disorder caused by the clonal proliferation of plasma cells. It has an incidence of about 4.5/100,000 per year in the U.S., making it the second most common hematologic malignancy. For many years, alkylating agents have been the backbone of treatment. The combination of melphalan and prednisone was, for many years, the standard of care for patients who were not candidates for autologous transplantation. Melphalan continues to be the primary conditioning agent for autologous transplant,and cyclophosphamide has also gained a foothold in the treatment of this disease.
The introduction of novel agents has fundamentally changed the landscape of treating this disease, although the true effects on survival are not yet known. Immunomodulatory agents and proteosome inhibitors, including thalidomide, lenalidomide and bortezomib have been used in both newly diagnosed and relapsed patients. Currently, there is intense clinical research on the optimal way to combine these novel agents with the traditional backbones of treatment - including alkylators, with one another and, eventually, with the subsequent iterations of these classes of drugs. However, despite the therapeutic excitement surrounding this disease, most patients will relapse and a cure remains an elusive goal.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 3 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Loyola University is the lead sponsor of 132 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bendamustine is combined with standard chemotherapy.
Drug: Bendamustine
The first group of three patients to enter the study will receive a 25 mg/m\^2 dose of bendamustine. If this dose is found to be safe, the next three patients will receive 50 mg/m\^2. Using a modified Fibonacci dose-escalation design, the dose will continue to increase at a rate of 25 mg/m\^2 until the highest safe dose of bendamustine is found. The maximum dose will be 125 mg/m\^2. Bendamustine and bortezomib will be given through a catheter twice a week every 21 days. Dexamethasone and lenalidomide will be given orally. In general, a cycle of chemotherapy will last 21 days.
Also known as: Treanda
Number of Patients Experiencing a Toxicity
The number of patients experiencing at least one toxicity at the lowest dose of bendamustine. A toxicity is defined as one or more of the following: Upper respiratory infection; anemia; thrombocytopenia; neutropenia; shortness of breath on exertion; decreased appetite; nausea; neuropathy; anxiety; arthritis; and hypercalcemia.
Time frame: 21 days
Participants were recruited from May 2011 through April 2014 (36 months) from the Cardinal Bernardin Cancer Center at Loyola University Medical Center
| Milestone | Bendamustine |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
The number of patients experiencing at least one toxicity at the lowest dose of bendamustine. A toxicity is defined as one or more of the following: Upper respiratory infection; anemia; thrombocytopenia; neutropenia; shortness of breath on exertion; decreased appetite; nausea; neuropathy; anxiety; arthritis; and hypercalcemia.
| Participants | Bendamustine |
|---|---|
| Experienced no toxicities | 0 |
| Experienced at least one toxicity | 3 |
Collected over Adverse event data were collected from November 2011 through June 2014 (32 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bendamustine | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Bendamustine |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 2/3 |
| Shortness of Breath on ExertionRespiratory, thoracic and mediastinal disorders | 2/3 |
| Upper respiratory infectionInfections and infestations | 1/3 |
| AnemiaBlood and lymphatic system disorders | 1/3 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/3 |
| Decreased appetiteGastrointestinal disorders | 1/3 |
| NauseaGastrointestinal disorders | 1/3 |
| NeuropathyNervous system disorders | 1/3 |
| AnxietyPsychiatric disorders | 1/3 |
| ArthritisEndocrine disorders | 1/3 |
The baseline analysis population comprises all participants who signed an informed consent document
| Age, Categorical(Participants) | Bendamustine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Bendamustine |
|---|---|
| Female | 1 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Bendamustine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Bendamustine |
|---|---|
| United States | 3 |
Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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