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Also known as Daratumumab Injection
Daratumumab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort A: ATZ (Run-In) | EXPERIMENTAL | Cohort A will involve a safety run-in to evaluate atezolizumab administered as a single agent in participants with relapsed or refractory MM who have received up to 3 lines of prior treatment. NOTE: This cohort has been completed. |
| Cohort B1: ATZ + LEN (Dose Escalation) | EXPERIMENTAL | Cohort B1 will involve a dose escalation to evaluate atezolizumab administered in combination with ascending-dose lenalidomide in participants with relapsed or refractory MM who have received up to 3 lines of prior treatment. NOTE: This cohort has been completed. |
| Cohort C: ATZ + LEN (Post-ASCT): | EXPERIMENTAL | Cohort C will evaluate atezolizumab administered in combination with lenalidomide in participants with MM who have measureable disease after ASCT. NOTE: This cohort is closed to enrollment. |
| Cohort D1: ATZ + DAR (Run-in) | EXPERIMENTAL | Cohort D1 will involve a safety run-in to evaluate atezolizumab administered in combination with daratumumab in participants with relapsed or refractory MM who have received up to 3 lines of prior treatment. |
| Cohort D2: ATZ + DAR (Expansion) | EXPERIMENTAL | Cohort D2 will involve an expansion to evaluate atezolizumab administered in combination with daratumumab in participants with relapsed or refractory MM who have received 2 but no more than 3 lines of prior treatment that must have included a PI and IMiD and are refractory to the last line of treatment. |
| Cohort D3: ATZ + DAR (Progressed) | EXPERIMENTAL | Cohort D3 will involve an expansion to evaluate atezolizumab in combination with daratumumab in participants with relapsed or refractory MM who have received 2 or more lines of prior treatment and have progressed with an anti-cluster of differentiation (CD) 38 monoclonal antibody, either alone or in combination, and are refractory to both a proteasome inhibitor (PI) and immunomodulatory drug (IMiD). |
| Cohort E1: ATZ + DAR + LEN (Dose Escalation) | EXPERIMENTAL | Cohort E1 will involve a dose escalation to evaluate atezolizumab administered in combination with daratumumab and ascending-dose lenalidomide in participants with relapsed or refractory MM who have received up to 3 lines of prior treatment. NOTE: This cohort is closed to enrollment. |
| Cohort E2: ATZ + DAR + LEN (Expansion) | EXPERIMENTAL | Cohort E2 will involve an expansion to evaluate atezolizumab administered in combination with daratumumab and the maximum tolerated dose (MTD) of lenalidomide determined in Cohort E1 in participants with relapsed or refractory MM who have received up to 3 lines of prior treatment. NOTE: This cohort is closed to enrollment. |
| Cohort F1: ATZ + DAR + POM (Dose Escalation) | EXPERIMENTAL | Cohort F1 will involve a dose escalation to evaluate atezolizumab administered in combination with daratumumab and ascending-dose pomalidomide in participants with relapsed or refractory MM who have received 4 or more lines of prior treatment and are refractory to the last line of treatment. NOTE: This cohort has been completed. |
| Cohort F2: ATZ + DAR + POM (Expansion) | ACTIVE_COMPARATOR | Cohort F2 will involve an expansion to evaluate atezolizumab administered in combination with daratumumab and the MTD of pomalidomide determined in Cohort F1 in participants with relapsed or refractory MM who have received 4 or more lines of prior treatment and are refractory to the last line of treatment. NOTE: This cohort is randomized. |
| Cohort F3: DAR + POM + Dexamethasone | ACTIVE_COMPARATOR | Cohort F3 is an expansion control arm for cohort F2. Participants will receive daratumumab in combination with pomalidomide at the MTD and dexamethasone. NOTE: This cohort is randomized. |
| Name | Type | Description |
|---|---|---|
| Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody | DRUG | Participants will receive intravenous (IV) atezolizumab until loss of clinical benefit, withdrawal, or study end. Cohorts A to C will receive 1200 milligrams (mg) on Day 1 of each 21-day cycle. Cohorts D to F (combination with daratumumab) will receive 840 mg on Days 2 and 16 of Cycle 1 and on Days 1 and 15 of each 28-day cycle thereafter. |
| Daratumumab | DRUG | Participants will receive 16 milligrams per kilogram (mg/kg) IV daratumumab until loss of clinical benefit, withdrawal, or study end. Treatment will be per the U.S. Package Insert and given on Days 1, 8, 15, 22 of Cycles 1 and 2; on Days 1 and 15 of Cycles 3 to 6; and on Day 1 of each 28-day cycle thereafter. |
| Lenalidomide | DRUG | Lenalidomide will be administered orally (PO) until loss of clinical benefit, withdrawal, or study end. Cohort B1 will receive 10, 15, or 25 mg, ascending-dose lenalidomide, on Days 1-14 of each 21-day cycle. Cohort C will receive 10 mg on Days 1-14 of each 21-day cycle, beginning in Cycle 4. Cohort E (combination with daratumumab) will receive 10, 15, or 25 mg on Days 1-21 of each 28-day cycle. Participants in Cohort E1 will receive ascending-dose lenalidomide, and those in Cohort E2 will receive lenalidomide at the MTD as determined in Cohort E1. |
| Pomalidomide | DRUG | Pomalidomide will be administered PO until loss of clinical benefit, withdrawal, or study end. Cohort F (combination with daratumumab) will receive 2 or 4 mg on Days 1-21 of each 28-day cycle. Participants in Cohort F1 will receive ascending-dose pomalidomide, and those in Cohort F2 will receive pomalidomide at the MTD as determined in Cohort F1. |
| Dexamethasone | DRUG | Participants will receive either 20mg or 40mg of dexamethasone PO every 7 days from Day 1 of each cycle. |
Inclusion Criteria: * Previous diagnosis of MM with objective evidence of measurable disease * Willing and able to undergo bone marrow aspiration and biopsy tissue sample collection during screening and on study * Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal...
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Daratumumab is an investigational drug being studied for the treatment of Multiple Myeloma. It is currently in Phase 1 clinical development. The drug is being evaluated in combination with other therapies, including atezolizumab and an immunomodulatory drug, to assess its safety and efficacy in patients with this condition.
Daratumumab is a monoclonal antibody, classified as a -mab (antibody) modality. It is designed to target specific proteins involved in the progression of Multiple Myeloma. The drug is being investigated for its ability to bind to these targets and potentially inhibit cancer cell growth, though detailed target information is not specified.
Daratumumab is being developed by Roche Holding AG, a biopharmaceutical company. The company's stock is traded under the ticker symbol RHHBY. Roche is conducting clinical trials to evaluate the safety and efficacy of Daratumumab in patients with Multiple Myeloma.
Daratumumab is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for the treatment of Multiple Myeloma, with one completed Phase 1 trial involving 85 participants.
Daratumumab has been studied in one clinical trial, identified as NCT02431208. This Phase 1 trial, titled 'A Study of Atezolizumab Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Participants With Multiple Myeloma,' was completed in the United States. The trial enrolled 85 participants and was active-controlled.
Yes, Daratumumab is also known as Daratumumab Injection. Both names refer to the same investigational drug being developed by Roche Holding AG for the treatment of Multiple Myeloma. The drug is currently in Phase 1 clinical development and has been evaluated in a completed clinical trial.