A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma
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| ClinicalTrials.gov Identifier: NCT05259839 |
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Recruitment Status :
Recruiting
First Posted : March 2, 2022
Last Update Posted : March 28, 2024
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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-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed.
ABBV-383 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. ABBV-383 co-administered with Pd, Rd, Dd, or Niro will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of ABBV-383, followed by a dose expansion phase to confirm the dose. Approximately 270 adult participants with R/R MM will be enrolled in the study in approximately 45 sites worldwide.
Participants will receive intravenous (IV) ABBV-383 co-administered with oral/IV Pd, oral/IV Rd, oral/IV/subcutaneous (SC) Dd, or oral/IV Niro 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, questionnaires and side effects.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsed/Refractory Multiple Myeloma | Drug: ABBV-383 Drug: Dexamethasone Drug: Lenalidomide Drug: Pomalidomide Drug: Nirogacestat Drug: Daratumumab | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 270 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Dose Escalation and Expansion Study of ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma |
| Actual Study Start Date : | October 20, 2022 |
| Estimated Primary Completion Date : | November 29, 2028 |
| Estimated Study Completion Date : | July 21, 2031 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A (ABBV-383 with Pomalidomide and Dexamethasone)
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive ABBV-383 with Pomalidomide and Dexamethasone.
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Drug: ABBV-383
Intravenous (IV) Infusion Drug: Dexamethasone Oral; Tablet or IV Infusion Drug: Pomalidomide Oral; Capsule |
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Experimental: Arm B (ABBV-383 with Lenalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Lenalidomide and Dexamethasone.
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Drug: ABBV-383
Intravenous (IV) Infusion Drug: Dexamethasone Oral; Tablet or IV Infusion Drug: Lenalidomide Oral; Capsule |
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Experimental: Arm C (ABBV-383 with Daratumumab and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Daratumumab and Dexamethasone.
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Drug: ABBV-383
Intravenous (IV) Infusion Drug: Dexamethasone Oral; Tablet or IV Infusion Drug: Daratumumab Subcutaneous Injection (SC) |
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Experimental: Arm D (ABBV-383 with Nirogacestat)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Nirogacestat.
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Drug: ABBV-383
Intravenous (IV) Infusion Drug: Nirogacestat Oral; Tablet |
- Number of Participants with Dose Limiting Toxicities (DLT) of ABBV-383 [ Time Frame: Up to approximately 28 Days ]DLT events as described in the protocol will be assessed.
- Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately 3 Years ]An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
- Overall Response Rate (ORR) [ Time Frame: Up to Approximately 3 Years ]ORR is defined as partial response(PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR); proportion of participants who achieved a PR or better.
- Progression-Free Survival (PFS) [ Time Frame: Up to Approximately 3 Years ]PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.
- Duration of Response (DOR) [ Time Frame: Up to Approximately 3 Years ]DOR will be defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first.
- Time-to-Progression (TTP) [ Time Frame: Up to Approximately 3 Years ]TTP is defined as the number of days from the date of first dose to the date of earliest disease progression.
- Percentage of Participants with Minimal Residual Disease Negativity (MRD) [ Time Frame: Up to Approximately 3 Years ]MRD is defined as the percentage of participants with assessment of the minimal residual disease.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
- Must have confirmed diagnosis of Relapsed/Refractory (R/R) Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
- Must have measurable disease as outlined in the protocol.
- Must be naïve to treatment with ABBV-383 and must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
- Has received prior MM treatment in Arms A, B, C, and D.
Exclusion Criteria:
- Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatment.
- Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancer therapy.
- Known central nervous system involvement Multiple Myeloma (MM).
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Has any of the following conditions:
- Nonsecretory MM.
- Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 10^9L circulating plasma cells by standard differential.
- Waldenstrom's macroglobulinemia.
- Light chain amyloidosis.
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
- Major surgery within 4 weeks prior to first dose or planned study participation.
- Acute infections within 14 days prior to first dose of study drug requiring therapy (antibiotic, antifungal or antiviral).
- Uncontrolled diabetes or hypertension within 14 days prior to first dose.
- Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose.
- Known active infection of evidence of active hepatitis B, evidence of active hepatitis C, human immunodeficiency virus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05259839
| Contact: ABBVIE CALL CENTER | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
Show 49 study locations
| Study Director: | TeneoOne Inc | TeneoOne Inc. |
| Responsible Party: | TeneoOne Inc. |
| ClinicalTrials.gov Identifier: | NCT05259839 |
| Other Study ID Numbers: |
M22-947 2021-005587-22 ( EudraCT Number ) |
| First Posted: | March 2, 2022 Key Record Dates |
| Last Update Posted: | March 28, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Relapsed/Refractory Multiple Myeloma Pomalidomide Dexamethasone Lenalidomide |
Daratumumab Nirogacestat ABBV-383 Cancer |
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone |
Lenalidomide Daratumumab Pomalidomide Nirogacestat Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |