RESEARCH STUDY
Do you have a patient with Relapsed or Refractory Multiple Myeloma (R/R MM)?
Consider referring your patients to the Kilimanjaro (M22-947) Study.
Our Study
The Kilimanjaro (M22-947) study is an open label phase 1b, dose escalation and expansion study designed to evaluate the safety profile, tolerability, preliminary efficacy, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-383 in combination with the following anti-myeloma regimens:
- ABBV-383 + pomalidomide-dexamethasone
- ABBV-383 + lenalidomide-dexamethasone
- ABBV-383 + daratumumab-dexamethasone
- ABBV-383 + nirogacestat
Bispecific T-cell engaging antibodies represent a new class of therapeutic agents that combine the target specificity and safety profile of mAbs with the potency of T-cell mediated cellular cytotoxicity. B-cell maturation antigen (also called TNFRSF17) is a member of the tumor necrosis factor receptor superfamily, with preferential expression occurring on mature B lymphocytes. B-cell maturation antigen is emerging as a key target in MM due to its highly selective expression in malignant plasma cells. Gamma secretase mediates protein cleavage to modulate membrane-bound BCMA (mbBCMA) and release a soluble BCMA (sBCMA) component that may lower the availability of the target for binding and preclinical data have shown that a GS-inhibitor (GSI) can prevent cleavage of mbBCMA and shedding of sBCMA.
ABBV-383 (previously referred to as TNB-383B) is a gene recombinant product (biopharmaceuticals) manufactured via Chinese hamster ovary cell line. ABBV-383 is a fully human bispecific antibody that targets BCMA on the surface of MM cells and CD3 on the surface of T-cells, resulting in T-cell activation and selective destruction of BCMA-positive MM cells. Preliminary results from first-in-human Phase 1 study of ABBV-383 monotherapy suggest that ABBV-383 monotherapy is active in R/R MM
(D’Souza A, Shah N, Rodriguez C, et al. A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen x CD3 Bispecific T-Cell Redirecting Antibody, in Patients with Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2022 Aug27; JCCO2201504. DOI: 10.1200/JCO.22.01504. Online ahead of print.).
Inclusion/Exclusion Criteria
Kilimanjaro is a Phase 1b clinical study of an investigational drug combination that is not approved by the US FDA or any other global health authorities in R/R MM. Safety and efficacy have not been established in R/R MM.
To determine if your patient may be eligible to participate in the study, they must meet all criteria found in the study protocol. The following highlights key eligibility criteria for the Kilimanjaro study:
- Adult male or female, at least 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance of ≤ 2.
- Subjects must have confirmed diagnosis of R/R MM with documented evidence of progression during or after the subject’s last treatment regimen based on the investigator’s determination of the IMWG criteria:
• Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma
• Refractory defined as disease that is nonresponsive (failure to achieve minimal response [MR] or development of progressive disease) while on primary or salvage therapy, or progresses within 60 days of last therapy
1. History of other active malignancies, including myelodysplastic syndrome within the past 3 years with the following exceptions:
- Adequately treated in situ carcinoma of the cervix uteri or the breast;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen levels off treatment;
- Previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
2. Evidence of an active Hepatitis B, Hepatitis C or human immunodeficiency virus infection.
3. Evidence of an active, severe SARS-CoV-2 infection.
Additional study criteria will apply.
Locations
The Kilimanjaro study is being conducted at approximately 49 sites across 7 countries. There are approximately 16 sites in the United States.
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 CenterÂ
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 CenterÂ
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
Connect
If you would like to learn more about the Kilimanjaro study and speak to a Principal Investigator to find out if your patients may be eligible, please complete the form below and you will be contacted by a member of the research team. Thank you for your interest.