For Patients with Relapsed or Refractory Multiple Myeloma

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Trial Summary

Official Title

Phase 1, Open-Label, Dose Escalation Study of I-131-CLR1404 in Patients With Relapsed or Refractory Multiple Myeloma

Status

Recruiting

Condition

Multiple Myeloma

Actual Start Date

February 2015

Estimated Primary Completion Date

September 2018

About the Trial

Dose Escalation Study of CLR 131 (also known as I-131-CLR1404) in Patients with Relapsed or Refractory Multiple Myeloma

Multiple myeloma (MM) is an incurable, monoclonal proliferation of plasma cells. Approximately 80,000 Americans are affected by MM with approximately 22,000 new cases diagnosed and 11,000 deaths each year. The introduction of newer therapies in the past twenty years, such as autologous stem cell transplantation and novel agents such as proteasome inhibitors and immune modulating drugs has improved outcomes, with current median overall survival estimates of 3-10 years depending on a number of patient-, disease- and treatment-related factors. However, despite these innovations, myeloma relapse is inevitable. Therefore, there is a clear need for improved therapies for MM and, in particular, for relapsed disease.

CLR 131 is a radioiodinated therapeutic that exploits the selective uptake and retention of phospholipid ethers (PLEs) by malignant cells. Cellectar Biosciences' novel cancer-targeted small-molecule compound (CLR 131) is radiolabeled with the isotope iodine-131 (I-131). Radioiodinated CLR 131 has been evaluated in over 60 xenograft and spontaneous (transgenic) tumor models. In all but two cases of hepatocellular carcinoma, CLR 131 demonstrated selective cancer cell uptake and retention. In various rodent tumor models, CLR 131 has also demonstrated tumor growth delay and prolongation of survival.

Detailed Info

Brief Summary

The primary objective of the study is to determine the safety and tolerability of I-131-CLR1404 as a single or multiple dose, with and without concurrent weekly dexamethasone, in patients with relapsed or refractory multiple myeloma who have previously been treated with, or are intolerant of, an immunomodulator and a proteasome inhibitor.

Study Phase

Phase 1

Estimated Enrollment

33

Estimated Primary Completion Date

September 2018

Study Type

Interventional

Interventions
  • Drug: I-131-CLR1404
  • Drug: dexamethasone
  • Drug: I-131-CLR1404
Sponsor

Cellectar Biosciences, Inc.

Eligibility

Gender

Male & Female

18+

Age

18 years and older

0-2

Eastern Cooperative Oncology Group Performance Status

>28

Last Bone Marrow Biopsy

At least 28 days

Inclusion Criteria

  • Histologically or cytologically confirmed multiple myeloma
  • Prior treatment with or intolerance to proteasome inhibitor and immunomodulator
  • Bone marrow biopsy within 28 days of study drug infusion demonstrating at least 5% plasma cell involvement
  • Progressive disease defined by any of following:
    • 25% increase in serum M-protein from lowest response value during (or after) last therapy and/or absolute increase in serum M-protein of > or equal to 0.5 g/dL; 25% increase in urine M-protein from lowest response value during (or after) last therapy and/or absolute increase in urine M-protein of > or equal to 200 mg/24h; 25% increase in bone marrow plasma cell percentage from lowest response value during (or after) last therapy - absolute bone marrow plasma cell percentage must be > or equal to 10% unless prior complete response when absolute bone marrow plasma cell percentage must be > or equal to 5%; new onset hypercalcemia > 11.5 mg/dL
  • Measurable disease defined by any of following: Serum M-protein > 1 g/dL; Urine M-protein > 200 mg/24h; Serum free light chain (FLC) assay: involved FLC level > or equal to 10 mg/dL provided serum FLC ratio is abnormal; subjects who are non-secretors will be considered on a case-by-case basis
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • Life expectancy of at least 6 months
  • Have initiative and means to be compliant with protocol and within geographical proximity to make required study visits as judged by Investigator
  • Subject or legal representative has ability to read, understand and provide written informed consent for study related procedures
  • Women of childbearing potential must have negative pregnancy test within 24 hours of enrollment
  • Women of childbearing potential and men who are able to father a child, must agree to use an effective contraception method during study and for 12 months following study drug administration

Exclusion Criteria

  • Grade 2 or greater toxicities due to previous therapies, subject to laboratory abnormalities listed below. Stable, tolerable Grade 2 adverse events may be allowed at discretion of Investigator
  • Prior external beam radiation therapy resulting in greater than 20% total bone marrow receiving greater than 20 Gy
  • Prior radioisotope therapy
  • Prior total body or hemi-body irradiation
  • Extradural tumor in contact with the spinal cord or tumor located where swelling in response to therapy may impinge upon spinal cord
  • Subject has any of following laboratory abnormalities: WBC < 3000/uL; ANC < 1500/uL; Hemoglobin < 8 g/dL; Estimated glomerular filtration rate < 30 mL/min/1.73 m2; ALT > 3 x ULN ; Bilirubin > 1.5 x ULN
  • Platelet count < 100,000/uL without full-dose anticogulation therapy
  • Platelet count < 150,000/uL with ongoing full-dose anticoagulation therapy
  • Clinically significant bleeding event, as judged by investigator, within prior 6 months
  • Chronic immunosuppressive therapy
  • Anti-platelet therapy, except low-dose aspirin for cardioprotection
  • PTT > 1.3 x ULN
  • INR > 1.3
  • Radiation therapy, chemotherapy, immunotherapy, investigational therapy or corticosteroid use within 2 weeks of or after eligibility-defining bone marrow biopsy. Bisphosphonates and denosumab are permitted if subject has been receiving for at least 90 days
  • History of hypersensitivity to iodine
  • Any other concomitant serious illness or organ system dysfunction in opinion of Investigator would either compromise subject safety or interfere with test drug safety evaluation
  • Major surgery within 6 weeks of enrollment
  • Known history of HIV, hepatitis C or hepatitis B infection
  • Pregnancy or breast-feeding

Enrollment

For more information on enrollment into the current CLR 131 trial, please contact us or visit clinicaltrials.gov for location information.

Contact Us Visit ClinicalTrials.gov

Frequently Asked Questions

Clinical trials are research studies that involve people. Through clinical trials, doctors find new ways to improve treatments and the quality of life for people with disease.

Researchers design cancer clinical trials to test new ways to:

  • Treat cancer
  • Find and diagnose cancer
  • Prevent cancer
  • Manage symptoms of cancer and side effects from its treatment

Clinical trials are the final step in a long process that begins with research in a lab. Before any new treatment is used with people in clinical trials, researchers work for many years to understand its effects on cancer cells in the lab and in animals. They also try to figure out the side effects it may cause.

Any time you or a loved one needs treatment for cancer, clinical trials are an option to think about. Trials are available for all stages of cancer. It is a myth that they are only for people who have advanced cancer that is not responding to treatment.

Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the trial, called a protocol. The protocol explains what will be done during the trial. It also contains information that helps the doctor decide if this treatment is right for you. The protocol includes information about:

  • The reason for doing the trial
  • Who can join the trial (called “eligibility criteria”)
  • How many people are needed for the trial
  • Any drugs or other treatments that will be given, how they will be given, the dose, and how often
  • What medical tests will be done and how often
  • What types of information will be collected about the people taking part3

Clinical Trial Phases and Their Purpose(s)

Phase 1

  • Find a safe dose
  • Decide how the treatment/medicine should be administered
  • Determine how the new treatment may impact the people who take it

Phase 2

  • Determine if the treatment has an effect on certain cancers or cancer types
  • Determine how the new treatment may impact the people who take it

Phase 3

  • Compare and contrast the treatment with the current standard treatment

Phase 4

  • Monitor and further asses the long-term safety and efficacy of the treatment
  • According to the National Cancer Institute, clinical trials are finding and creating new ways of treating, diagnosing and even preventing cancer so that ultimately, care and quality of life for people with cancer can improve.1
  • In addition to testing new ways of treating and diagnosing cancer, clinical trials are also used to determine the best uses and combinations of existing therapies to combat cancer and to improve patient care and quality of life for cancer patients both during and after their treatments.1
  • Ultimately, thousands of people have volunteered over the years for clinical trials and it is because of those patients, and dedicated medical and research personnel that we now have so many breakthroughs in disease and cancer prevention within the last 50 years.2

Myth #1: Patients who are involved in clinical trials are treated like guinea pigs

FACT: Clinical trial patients often report that they have been treated with the utmost care, compassion and respect during their clinical trial treatment(s). Also, clinical trials are highly regulated and many safeguards have been put into place to protect patients and their best interest.6


Myth #2: Some patients receive placebos and some receive the real treatments

FACT: All patients who enroll in a clinical trial will receive the best treatment available to treat their type and stage of cancer. Placebos are very rarely used in cancer clinical trials and if they are, they are given in addition to the current standard of care and the patient is told that it is happening.4


Myth #3: Clinical trials are unaffordable and/or not covered by insurance

FACT: Volunteers for clinical trials rarely have to pay any costs related to participating in the trial. There are two types of costs associated with a clinical trial: research costs and patient care costs. Research costs are those associated with conducting the trial, such as data collection and management, research physician and nurse time, analysis of results, and tests performed purely for research purposes. These costs are usually covered by the sponsoring organization, such as the biopharmaceutical company, and are not the patient's responsibility. Patient care costs are costs that are not covered by the research sponsors doing the clinical trial, such as the costs for routine care including doctor visits, hospital stays, clinical laboratory tests, x-rays and other clinical trial-related activities that would be done even if you were not in the trial. Many health insurance carriers will cover patient care costs, but you should ask the clinical trial research team which costs will be your responsibility and also check with your health insurance carrier about the coverage they provide for clinical trial participants before making the decision about participating in a clinical trial.6


Myth #4: Clinical trials are only for people who have tried all other treatments and have run out of options.

FACT: Understanding the phases described above can help to answer this question. In some cases the answer may be yes – if nothing else is working a Phase 1 trial may help you further research for others with your disease (and has a small chance of making a difference for you as well.) But usually, people participate in clinical trials for other reasons. Cancer clinical trials are available for people at all stages of their disease.5


Myth #5: Once a patient agrees to be involved in a clinical trial, they are required to follow through to the end.

FACT: Clinical trials rely on voluntary participation. You are free to leave a clinical trial at any time, even after you have signed an informed consent and received the investigational drug or placebo. However, you should always let the clinical trial team know before you decide to leave the trial because some medicines cannot be stopped safely without a doctor’s help.6


Myth #6: If there is a clinical trial available that might help me, my doctor will definitely tell me about it.

FACT: Your doctor may not know about all available clinical trials that might benefit you. The National Institutes of Health has an online database that you, your family or doctor can search to find appropriate trials: www.clinicaltrials.gov. Alternatively, it’s often worth making contact with a patient advocacy organization to help you navigate the process. Many of them have tailored services that can help you with your search and help you understand the options.

 If you are thinking about participating in a clinical trial and have additional questions, you should talk to your doctor or a patient advocacy organization for your disease or condition.6

National and international regulations and policies have been developed to help ensure that research involving people is conducted according to strict scientific and ethical principles. In these regulations and policies, people who participate in research are usually referred to as "human subjects."

Clinical trials are reviewed by the country's regulatory department. For example, in the US, clinical trials are reviewed by the U.S. Food and Drug Administration (FDA) and in Canada, that review is done by Health Canada.

In addition, each hospital that conducts a clinical trial must have the study reviewed and approved by an Institutional Review Board (IRB). The IRB reviews all aspects of a clinical trial to make sure that the rights, safety, and well-being of trial participants will be protected. The IRB must also review ongoing trials at least yearly and, based on those reviews, can decide whether the trial should continue as initially planned or if changes should be made to improve participant protection. An IRB can stop a clinical trial if the researchers are not following the protocol or if the trial appears to be causing unexpected harm to the study participants.

An IRB must have at least five members, including one scientist, one person who is not a scientist, and one person who is not affiliated with the institution where the trial is taking place and who is not an immediate family member of someone who is affiliated with that institution. The nonscientist and the nonaffiliated member can be the same person. IRBs can also include doctors, nurses, social workers, chaplains, patient advocates, and other health care or community professionals. All members of an IRB are required to be educated about the IRB's purpose, functions, and responsibilities, as outlined in federal regulations. Trials taking place at multiple locations can involve multiple IRBs.

Clinical trials also may use a Data and Safety Monitoring Board (DSMB) or a safety monitoring committee to monitor the safety and progress of the trials.

A DSMB is a committee of doctors, statisticians, and others who are independent of the people, organizations, and institutions that are sponsoring, organizing, and conducting the clinical trial. Similar to IRBs, DSMBs review the progress of a clinical trial and participant safety, but they also review data on the effectiveness of the trial interventions. DSMB members are experts in clinical research and clinical trials. They ensure that trial data are complete, and they can stop a trial early if safety concerns arise or if an answer to the main research question is obtained earlier than expected. Stopping a trial early because the main research question has been answered may make it possible for people who are not in the trial to get access to an effective intervention sooner. DSMBs have scheduled meetings to review clinical data, and their meeting minutes or recommendations are forwarded to the IRBs.7

References:

  1. "Clinical Trials." National Cancer Institute. National Institutes of Health. http://www.cancer.gov/research/areas/clinical-trials
  2. "The Importance of Clinical Trials - Policy and Medicine." Policy and Medicine. Policy and Medicine Online. http://www.policymed.com/2010/05/the-importance-of-clinical-trials.html
  3. "What Are Clinical Trials?" National Cancer Institute. National Institutes of Health. http://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials
  4. "Placebo." National Cancer Institute. National Institutes of Health. http://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials/placebo
  5. "Top 10 Myths About Clinical Trials for Cancer." https://www.verywell.com/myths-about-clinical-trials-for-cancer-2249004
  6. "Debunking Common Myths About Clinical Trials." Debunking Common Myths About Clinical Trials. Catalyst Pharma. http://catalyst.phrma.org/debunking-common-myths-about-clinical-trials
  7. "Cancer Clinical Trials."National Cancer Institute, National Institutes of Health. http://www.cancer.gov/research/areas/clinical-trials

The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.