RESEARCH STUDY

Were you diagnosed with Relapsed or Refractory Multiple Myeloma? Has the disease come back, even after multiple treatments?

Explore your options. Consider participating in the Kilimanjaro study.

About
relapsed or refractory multiple myeloma

Multiple myeloma is a cancer that affects a type of white blood cell, called a plasma cell, that helps the immune system fight infections. Sometimes, cancer will respond to treatment but then become resistant to the treatment and start growing again. When this happens with multiple myeloma, it is called Relapsed or Refractory Multiple Myeloma 1.

Currently, there are few treatment options for people with relapsed or refractory multiple myeloma. Approved treatments may include medications that can slow how fast the myeloma cells multiply, medications that block how fast myeloma can grow and medications that can help the immune system fight the myeloma 1.

 1 Watson, S. (2021, April 21). Refractory multiple myeloma. WebMD. Retrieved October 13, 2022, from https://www.webmd.com/cancer/multiple-myeloma/refractory-multiple-myeloma

Our Study

An investigational drug combination is being studied for use in patients who have relapsed or refractory multiple myeloma. The investigational drug is not approved by the United States Food and Drug Administration (FDA), or any other global regulatory agency and the safety and activity are under evaluation.

Our investigational drug, called ABBV-383, is being studied in patients with relapsed or refractory multiple myeloma to determine if it is safe and effective when given via an intravenous infusion with standard of care anti-myeloma treatments.

The purpose of the Kilimanjaro study is to compare the investigational drug in various dosages, when combined with other approved treatments for multiple myeloma, to determine if anti-tumor activity seen with these medications is enhanced with ABBV-383. In the Kilimanjaro study, participants will be assigned to receive the investigational drug in combination with either a standard anti-multiple myeloma therapy or another investigational therapy. Study participants will be followed closely with clinic visits and tests.

There are important criteria that you must meet to be eligible to participate in Kilimanjaro. The following highlights a few key eligibility criteria:

To determine if you meet all eligibility criteria and may be a candidate to participate in Kilimanjaro, you will need to be evaluated by a study physician (principal investigator).

Locations

The Kilimanjaro study is being conducted at approximately 49 sites across 7 countries. There are approximately 16 sites in the United States.
If you do not see a location near you, please visit clinicaltrials.gov for a complete list of study locations.

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin

University of Washington

Seattle, Washington

Huntsman Cancer Institute

Salt Lake City, Utah

University of Texas Southwestern Medical Center

Dallas, Texas

Levine Cancer Institute

Charlotte, North Carolina

Memorial Sloan Kettering Cancer Center

New York, New York

Rutenberg Cancer Center 

New York, New York

The Valley Hospital

Paramus, New Jersey

University of Michigan Comprehensive Cancer Center Michigan Medicine

Ann Arbor, Michigan

University of Massachusetts – Worcester

Worcester, Maryland

Dana-Farber Cancer Institute

Boston, Massachusetts

University of Maryland School of Medicine

Baltimore, Maryland

Moffitt Cancer Center

Tampa, Florida

Sylvester Comprehensive Cancer Center

Miami, Florida

University of Arkansas for Medical Sciences

Little Rock, Arkansas

University of Arkansas for Medical Sciences
Little Rock, Arkansas

Sylvester Comprehensive Cancer Center
Miami, Florida

Moffitt Cancer Center
Tampa, Florida

University of Maryland School of Medicine
Baltimore, Maryland

Dana-Farber Cancer Institute
Boston, Massachusetts

University of Massachusetts - Worcester
Worcester, Massachusetts

University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan

The Valley Hospital
Paramus, New Jersey

Rutenberg Cancer Center 
New York, New York

Memorial Sloan Kettering Cancer Center
New York, New York

Levine Cancer Institute
Charlotte, North Carolina

University of Texas Southwestern Medical Center
Dallas, Texas

Huntsman Cancer Institute
Salt Lake, Utah

University of Washington
Seattle, Washington

Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin

Do I Qualify?

In order to see if you might be eligible, we need to ask you some quick questions. If you pre-qualify, you can submit your contact information to the local study center. The study coordinator will then contact you to tell you more about the study, answer your questions and possibly schedule a visit to the research center.

If you are answering these questions on behalf of the person with multiple myeloma, please provide responses from their perspective (i.e., provide their date of birth, etc.)

Frequently Asked Questions

A clinical research study is medical research to learn more about investigational new drugs or unapproved new drugs. Clinical research studies help us understand safety and effectiveness of the investigational medication being researched.

Patients have different reasons for participating in clinical research, including:

  • Contributing to the advancement of science
  • Gaining access to investigational medications or study procedures that otherwise would be unavailable options.

You will first go through a screening process at the study site. If you are eligible for the Kilimanjaro study, you will be assigned to receive one of the following treatment options:

  • ABBV-383 + pomalidomide-dexamethasone
  • ABBV-383 + lenalidomide-dexamethasone
  • ABBV-383 + daratumumab-dexamethasone 
  • ABBV-383 + nirogacestat (Another investigational agent)

Post-treatment information will be collected every 12 weeks for approximately 1 year post study completion.

You may qualify to participate if you meet the following requirements:

  • You must be 18 years of age or older
  • You must have been diagnosed with relapsed or refractory multiple myeloma
  • You must have tried at least 3 courses of treatment for your multiple myeloma in the past
  • You do not need chemotherapy to treat other forms of cancer
  • You do not have an active, systemic infection including COVID-19, HIV, Hepatitis B or Hepatitis C
  • You are not currently enrolled in another clinical study

Additional study criteria will apply.

Study participants are expected to attend all clinic visits and complete all study procedures according to the study doctor’s instructions to ensure we can understand how the treatment is working.  You may receive reimbursement for study-related costs and expenses. The study team can provide more details if you do qualify and are considering participation.

Your participation in the study is voluntary—you can stop participating at any time for any reason without any penalty or loss of benefits to which you may otherwise be entitled.