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VOB560-MIK665 - Part 2a for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Yale University School of Medicine Smilow Cancer Hospital, New Haven, CTMultiple Myeloma+2 MoreMIK665 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trialwill test if VOB560 and MIK665 can safely be given together and if it can help treat NHL, MM or AML.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Multiple Myeloma
  • Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 15 Secondary · Reporting Duration: at month 18

Day 21
Apparent volume of distribution (Vz) of MIK665
Apparent volume of distribution (Vz) of VOB560
Area Under Curve (AUC) of MIK665
Area Under Curve (AUC) of VOB560
Clearance (CL) of MIK665
Clearance (CL) of VOB560
Maximum Plasma Concentration (Cmax) ok MIK665
Maximum Plasma Concentration (Cmax) ok VOB560
Terminal elimination half-life (T1/2) of MIK665
Terminal elimination half-life (T1/2) of VOB560
at month 18
Best Overall Response (BOR)
Complete Response (CR) rate (and rate of CR or sCR in R/R MM)
Dose intensities
Duration Of Response (DOR)
Frequency of dose interruptions
Frequency of dose reductions
Incidence and severity of AEs and SAEs, including changes in lab values, vital signs, and ECGs
Incidence of Dose Limiting Toxicities (DLTs) during the first cycle of treatment with VOB560 and MIK665 in combination
Overall Response Rate (ORR)
Progression Free Survival (PFS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
[68Ga]-Pentixafor
1
RO7425781
1
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Trial Design

6 Treatment Groups

VOB560-MIK665 - Part 2a
1 of 6
VOB560-MIK665 - Part 2b
1 of 6
VOB560-MIK665 - Part 1b
1 of 6
VOB560-MIK665 - Part 1a
1 of 6
VOB560-MIK665 - Part 2d
1 of 6
VOB560-MIK665 - Part 2c
1 of 6

Experimental Treatment

170 Total Participants · 6 Treatment Groups

Primary Treatment: VOB560-MIK665 - Part 2a · No Placebo Group · Phase 1

VOB560-MIK665 - Part 2aExperimental Group · 2 Interventions: MIK665, VOB560 · Intervention Types: Drug, Drug
VOB560-MIK665 - Part 2bExperimental Group · 2 Interventions: MIK665, VOB560 · Intervention Types: Drug, Drug
VOB560-MIK665 - Part 1bExperimental Group · 2 Interventions: MIK665, VOB560 · Intervention Types: Drug, Drug
VOB560-MIK665 - Part 1aExperimental Group · 2 Interventions: MIK665, VOB560 · Intervention Types: Drug, Drug
VOB560-MIK665 - Part 2dExperimental Group · 2 Interventions: MIK665, VOB560 · Intervention Types: Drug, Drug
VOB560-MIK665 - Part 2cExperimental Group · 2 Interventions: MIK665, VOB560 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MIK665
2017
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at month 18

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,738 Previous Clinical Trials
3,544,044 Total Patients Enrolled
38 Trials studying Multiple Myeloma
2,459 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

What are the goals of this clinical research?

"The primary goal of this clinical trial is to assess the incidence of dose-limiting toxicities (DLTs) during the first cycle of treatment with VOB560 and MIK665 in combination. Secondary outcomes include apparent volume of distribution (Vz) of VOB560, overall response rate (ORR), and area under curve (AUC) of MIK665." - Anonymous Online Contributor

Unverified Answer

Are there harmful effects to taking VOB560-MIK665 - Part 2a?

"This medication, VOB560-MIK665 - Part 2a, is still in Phase 1 of clinical trials. This limits the available data regarding both its safety and efficacy, thus it was given a score of 1." - Anonymous Online Contributor

Unverified Answer

How many candidates are being enrolled in this study?

"That is correct. The website clinicaltrials.gov has the most recent information about this study, which began recruiting on 6/23/2021. As of 10/21/2022, the trial is still recruiting and looking for 170 participants from 1 location." - Anonymous Online Contributor

Unverified Answer

Are there any available positions for patients in this trial?

"The trial is currently active and looking for participants, with the most recent update on 10/21/2022. 170 patients are needed from 1 medical site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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